Journal of Clinical and Diagnostic Research, ISSN - 0973 - 709X

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On Sep 2018




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Prof. Somashekhar Nimbalkar
Head, Department of Pediatrics, Pramukhswami Medical College, Karamsad
Chairman, Research Group, Charutar Arogya Mandal, Karamsad
National Joint Coordinator - Advanced IAP NNF NRP Program
Ex-Member, Governing Body, National Neonatology Forum, New Delhi
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On Sep 2018




Dr. Kalyani R

"Journal of Clinical and Diagnostic Research is at present a well-known Indian originated scientific journal which started with a humble beginning. I have been associated with this journal since many years. I appreciate the Editor, Dr. Hemant Jain, for his constant effort in bringing up this journal to the present status right from the scratch. The journal is multidisciplinary. It encourages in publishing the scientific articles from postgraduates and also the beginners who start their career. At the same time the journal also caters for the high quality articles from specialty and super-specialty researchers. Hence it provides a platform for the scientist and researchers to publish. The other aspect of it is, the readers get the information regarding the most recent developments in science which can be used for teaching, research, treating patients and to some extent take preventive measures against certain diseases. The journal is contributing immensely to the society at national and international level."



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Professor and Head
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Saraswati Dental College
Lucknow
On Sep 2018




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MD, DM (Clinical Pharmacology)
Assistant Professor
Department of Pharmacology
Calcutta National Medical College & Hospital , Kolkata




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Best regards,
C.S. Ramesh Babu,
Associate Professor of Anatomy,
Muzaffarnagar Medical College,
Muzaffarnagar.
On Aug 2018




Dr. Arundhathi. S
"Journal of Clinical and Diagnostic Research (JCDR) is a reputed peer reviewed journal and is constantly involved in publishing high quality research articles related to medicine. Its been a great pleasure to be associated with this esteemed journal as a reviewer and as an author for a couple of years. The editorial board consists of many dedicated and reputed experts as its members and they are doing an appreciable work in guiding budding researchers. JCDR is doing a commendable job in scientific research by promoting excellent quality research & review articles and case reports & series. The reviewers provide appropriate suggestions that improve the quality of articles. I strongly recommend my fraternity to encourage JCDR by contributing their valuable research work in this widely accepted, user friendly journal. I hope my collaboration with JCDR will continue for a long time".



Dr. Arundhathi. S
MBBS, MD (Pathology),
Sanjay Gandhi institute of trauma and orthopedics,
Bengaluru.
On Aug 2018




Dr. Mamta Gupta,
"It gives me great pleasure to be associated with JCDR, since last 2-3 years. Since then I have authored, co-authored and reviewed about 25 articles in JCDR. I thank JCDR for giving me an opportunity to improve my own skills as an author and a reviewer.
It 's a multispecialty journal, publishing high quality articles. It gives a platform to the authors to publish their research work which can be available for everyone across the globe to read. The best thing about JCDR is that the full articles of all medical specialties are available as pdf/html for reading free of cost or without institutional subscription, which is not there for other journals. For those who have problem in writing manuscript or do statistical work, JCDR comes for their rescue.
The journal has a monthly publication and the articles are published quite fast. In time compared to other journals. The on-line first publication is also a great advantage and facility to review one's own articles before going to print. The response to any query and permission if required, is quite fast; this is quite commendable. I have a very good experience about seeking quick permission for quoting a photograph (Fig.) from a JCDR article for my chapter authored in an E book. I never thought it would be so easy. No hassles.
Reviewing articles is no less a pain staking process and requires in depth perception, knowledge about the topic for review. It requires time and concentration, yet I enjoy doing it. The JCDR website especially for the reviewers is quite user friendly. My suggestions for improving the journal is, more strict review process, so that only high quality articles are published. I find a a good number of articles in Obst. Gynae, hence, a new journal for this specialty titled JCDR-OG can be started. May be a bimonthly or quarterly publication to begin with. Only selected articles should find a place in it.
An yearly reward for the best article authored can also incentivize the authors. Though the process of finding the best article will be not be very easy. I do not know how reviewing process can be improved. If an article is being reviewed by two reviewers, then opinion of one can be communicated to the other or the final opinion of the editor can be communicated to the reviewer if requested for. This will help one’s reviewing skills.
My best wishes to Dr. Hemant Jain and all the editorial staff of JCDR for their untiring efforts to bring out this journal. I strongly recommend medical fraternity to publish their valuable research work in this esteemed journal, JCDR".



Dr. Mamta Gupta
Consultant
(Ex HOD Obs &Gynae, Hindu Rao Hospital and associated NDMC Medical College, Delhi)
Aug 2018




Dr. Rajendra Kumar Ghritlaharey

"I wish to thank Dr. Hemant Jain, Editor-in-Chief Journal of Clinical and Diagnostic Research (JCDR), for asking me to write up few words.
Writing is the representation of language in a textual medium i e; into the words and sentences on paper. Quality medical manuscript writing in particular, demands not only a high-quality research, but also requires accurate and concise communication of findings and conclusions, with adherence to particular journal guidelines. In medical field whether working in teaching, private, or in corporate institution, everyone wants to excel in his / her own field and get recognised by making manuscripts publication.


Authors are the souls of any journal, and deserve much respect. To publish a journal manuscripts are needed from authors. Authors have a great responsibility for producing facts of their work in terms of number and results truthfully and an individual honesty is expected from authors in this regards. Both ways its true "No authors-No manuscripts-No journals" and "No journals–No manuscripts–No authors". Reviewing a manuscript is also a very responsible and important task of any peer-reviewed journal and to be taken seriously. It needs knowledge on the subject, sincerity, honesty and determination. Although the process of reviewing a manuscript is a time consuming task butit is expected to give one's best remarks within the time frame of the journal.
Salient features of the JCDR: It is a biomedical, multidisciplinary (including all medical and dental specialities), e-journal, with wide scope and extensive author support. At the same time, a free text of manuscript is available in HTML and PDF format. There is fast growing authorship and readership with JCDR as this can be judged by the number of articles published in it i e; in Feb 2007 of its first issue, it contained 5 articles only, and now in its recent volume published in April 2011, it contained 67 manuscripts. This e-journal is fulfilling the commitments and objectives sincerely, (as stated by Editor-in-chief in his preface to first edition) i e; to encourage physicians through the internet, especially from the developing countries who witness a spectrum of disease and acquire a wealth of knowledge to publish their experiences to benefit the medical community in patients care. I also feel that many of us have work of substance, newer ideas, adequate clinical materials but poor in medical writing and hesitation to submit the work and need help. JCDR provides authors help in this regards.
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Indexation and online availability: Indexation transforms the journal in some sense from its local ownership to the worldwide professional community and to the public.JCDR is indexed with Embase & EMbiology, Google Scholar, Index Copernicus, Chemical Abstracts Service, Journal seek Database, Indian Science Abstracts, to name few of them. Manuscriptspublished in JCDR are available on major search engines ie; google, yahoo, msn.
In the era of fast growing newer technologies, and in computer and internet friendly environment the manuscripts preparation, submission, review, revision, etc and all can be done and checked with a click from all corer of the world, at any time. Of course there is always a scope for improvement in every field and none is perfect. To progress, one needs to identify the areas of one's weakness and to strengthen them.
It is well said that "happy beginning is half done" and it fits perfectly with JCDR. It has grown considerably and I feel it has already grown up from its infancy to adolescence, achieving the status of standard online e-journal form Indian continent since its inception in Feb 2007. This had been made possible due to the efforts and the hard work put in it. The way the JCDR is improving with every new volume, with good quality original manuscripts, makes it a quality journal for readers. I must thank and congratulate Dr Hemant Jain, Editor-in-Chief JCDR and his team for their sincere efforts, dedication, and determination for making JCDR a fast growing journal.
Every one of us: authors, reviewers, editors, and publisher are responsible for enhancing the stature of the journal. I wish for a great success for JCDR."



Thanking you
With sincere regards
Dr. Rajendra Kumar Ghritlaharey, M.S., M. Ch., FAIS
Associate Professor,
Department of Paediatric Surgery, Gandhi Medical College & Associated
Kamla Nehru & Hamidia Hospitals Bhopal, Madhya Pradesh 462 001 (India)
E-mail: drrajendrak1@rediffmail.com
On May 11,2011




Dr. Shankar P.R.

"On looking back through my Gmail archives after being requested by the journal to write a short editorial about my experiences of publishing with the Journal of Clinical and Diagnostic Research (JCDR), I came across an e-mail from Dr. Hemant Jain, Editor, in March 2007, which introduced the new electronic journal. The main features of the journal which were outlined in the e-mail were extensive author support, cash rewards, the peer review process, and other salient features of the journal.
Over a span of over four years, we (I and my colleagues) have published around 25 articles in the journal. In this editorial, I plan to briefly discuss my experiences of publishing with JCDR and the strengths of the journal and to finally address the areas for improvement.
My experiences of publishing with JCDR: Overall, my experiences of publishing withJCDR have been positive. The best point about the journal is that it responds to queries from the author. This may seem to be simple and not too much to ask for, but unfortunately, many journals in the subcontinent and from many developing countries do not respond or they respond with a long delay to the queries from the authors 1. The reasons could be many, including lack of optimal secretarial and other support. Another problem with many journals is the slowness of the review process. Editorial processing and peer review can take anywhere between a year to two years with some journals. Also, some journals do not keep the contributors informed about the progress of the review process. Due to the long review process, the articles can lose their relevance and topicality. A major benefit with JCDR is the timeliness and promptness of its response. In Dr Jain's e-mail which was sent to me in 2007, before the introduction of the Pre-publishing system, he had stated that he had received my submission and that he would get back to me within seven days and he did!
Most of the manuscripts are published within 3 to 4 months of their submission if they are found to be suitable after the review process. JCDR is published bimonthly and the accepted articles were usually published in the next issue. Recently, due to the increased volume of the submissions, the review process has become slower and it ?? Section can take from 4 to 6 months for the articles to be reviewed. The journal has an extensive author support system and it has recently introduced a paid expedited review process. The journal also mentions the average time for processing the manuscript under different submission systems - regular submission and expedited review.
Strengths of the journal: The journal has an online first facility in which the accepted manuscripts may be published on the website before being included in a regular issue of the journal. This cuts down the time between their acceptance and the publication. The journal is indexed in many databases, though not in PubMed. The editorial board should now take steps to index the journal in PubMed. The journal has a system of notifying readers through e-mail when a new issue is released. Also, the articles are available in both the HTML and the PDF formats. I especially like the new and colorful page format of the journal. Also, the access statistics of the articles are available. The prepublication and the manuscript tracking system are also helpful for the authors.
Areas for improvement: In certain cases, I felt that the peer review process of the manuscripts was not up to international standards and that it should be strengthened. Also, the number of manuscripts in an issue is high and it may be difficult for readers to go through all of them. The journal can consider tightening of the peer review process and increasing the quality standards for the acceptance of the manuscripts. I faced occasional problems with the online manuscript submission (Pre-publishing) system, which have to be addressed.
Overall, the publishing process with JCDR has been smooth, quick and relatively hassle free and I can recommend other authors to consider the journal as an outlet for their work."



Dr. P. Ravi Shankar
KIST Medical College, P.O. Box 14142, Kathmandu, Nepal.
E-mail: ravi.dr.shankar@gmail.com
On April 2011
Anuradha

Dear team JCDR, I would like to thank you for the very professional and polite service provided by everyone at JCDR. While i have been in the field of writing and editing for sometime, this has been my first attempt in publishing a scientific paper.Thank you for hand-holding me through the process.


Dr. Anuradha
E-mail: anuradha2nittur@gmail.com
On Jan 2020

Important Notice

Original article / research
Year : 2022 | Month : December | Volume : 16 | Issue : 12 | Page : QC27 - QC32 Full Version

Trushield NXT Non Adherent Wound Dressing versus Standard of Care Dressing among Women Undergoing Obstetric and Gynaecological Surgeries: A Randomised Clinical Study


Published: December 1, 2022 | DOI: https://doi.org/10.7860/JCDR/2022/59719.17350
Rathindranath Ray, Rehana Sarkar, Subhalaxmi Gupta, Tirna Halder

1. Assistant Professor, Department of Obstetrics and Gynaecology, Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital, Kolkata, West Bengal, India. 2. Assistant Professor, Department of Microbiology, Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital, Kolkata, West Bengal, India. 3. Postgraduate Resident, Department of Microbiology, Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital, Kolkata, West Bengal, India. 4. Director, Department of Clinical Research, Vita Eternia Clinical Solutions Pvt. Ltd., Kolkata, West Bengal, India.

Correspondence Address :
Dr. Rathindranath Ray,
Assistant Professor, Department of Obstetrics and Gynaecology, Institute of Post Graduate Medical Education and Research and SSKM Hospital, Kolkata, West Bengal, India.
E-mail: rathindra24@yahoo.com

Abstract

Introduction: Surgical Site Infection (SSI) is the most frequently reported postsurgical wound complication worldwide. Trushield NXT is a non adherent dressing with a unique non leaching physical mechanism of action antimicrobial property, whereas the Standard of Care (SOC) dressing is made with cotton, povidone, and leucoplast which is primarily used as a barrier dressing.

Aim: To compare the effectiveness of Trushield NXT non adherent wound dressing over SOC dressing (cotton+povidone+leucoplast) in postoperative wound management of obstetric and gynaecological surgeries.

Materials and Methods: This was an investigator-initiated, single-centre, prospective, two-arm, parallel-group, randomised (1:1) clinical study conducted in the Department of Obstetrics and Gynaecology, Institute of Post-Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital, Kolkata, West Bengal, India, between 7th February 2022 and 18th May 2022. A total of 114 patients were screened but finally 111 were selected for the study and randomised to Trushield NXT non adherent wound dressing (n=56) and SOC (n=55) groups. Women in the age group of 18-65 years, undergoing obstetric and/or gynaecological surgeries at the site were enrolled in the study after fulfilling the inclusion and exclusion criteria. Patients underwent surgery (caesarean section/hysterectomy) as per the standard institutional practice and were followed-up on day 3±1, day 8±1, day 42±7. The primary endpoint was the evaluation of SSI using the Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria and Stay (ASEPSIS) scoring system, along with dressing time and the number of dressing changes. The secondary endpoints include assessment of pain using a Visual Analog Scale (VAS), and pain during dressing removal, evaluation of ease of application/usage/removal of the dressing, modified Hollander wound score scale, wound healing score, and patient satisfaction of wound dressing and wound healing. Statistical analysis was done using Student’s t-test or Mann-Whitney U test for continuous variables or Moses’ test for extreme reaction. A p-value of ≤0.05 was considered significant.

Results: The mean age of participants in the Trushield NXT and SOC group was 28.38±4.97 and 27.28±6.03, respectively. Statistically significant difference favouring Trushield NXT was observed between the two groups of Trushield NXT and SOC in terms of ASEPSIS scoring (6.97±0.63 vs. 7.04±0.61; p-value <0.0001), dressing time (39.16 vs 101.07 secs; p-value <0.0001), pain score (3.28 vs 3.82; day 8), pain during dressing removal (30.63 vs 59.2; p-value <0.0001) and patient satisfaction (3.71 vs 3.24; p-value <0.0001).

Conclusion: Trushield NXT was found to be superior to SOC for postoperative wound management in obstetric and gynaecological surgeries.

Keywords

ASEPSIS score, Cotton dressing, Pain, Surgical site infection

The Centre for Disease Control and Prevention (CDC) defines Surgical Site Infection (SSI) as an infection related to a surgical procedure that occurs near the surgical site within 30 days following surgery (or up to 90 days following surgery where an implant is involved) (1). Among hospital-acquired infections in lower-income and middle-income countries, SSI is the most frequently reported one, accounting for approximately 11.8% cases (2),(3). For postoperative morbidity and mortality, SSI is one of the major contributors in India, and the range varies from 1.6-3.8% depending on the surgery type, hospital setting, administration of the perioperative or prophylactic antibiotics, and patient co-morbidities (4),(5). A meta-analysis emphasises the explicit relationship between wound dressing and SSI. As a surgical incision site is at high risk of microbial colonisation, in such cases, a wound dressing with additional infection-preventing properties may prevent such infections and protect the wound from microbial contamination (6).

Trushield NXT non adherent wound dressing is a 3-Dimensional (3D) knitted hydrocellular textile substrate made of Polyethylene Terephthalate (PET) and Polyurethane (PU), which is permanently bound and cross polymerised, cross-linked with “Dimethyl Tetradecyl {3-(trimethoxysilyl) propyl} Ammonium Chloride” (DTAC) that is immobilised on the substrate and does not leach out of the dressing (7). It is already a marketed product with evidence of comparative benefits, generated based on the the oretical properties and personal experience of its use by surgeons. Standard of Care (SOC) dressing includes povidone-iodine solution and cotton gauze which is secured in place by a leucoplast adhesive pad. An in-vitro study conducted to assess the antimicrobial properties of the Trushield NXT dressing, suggests that it shields against a wide range of microorganisms over a time period of one minute to 28 days thus supporting effective and significant wound healing (8). Till now, there is no randomised clinical trial conducted with Trushield NXT non adherent wound dressing, Hence, there is a need to generate robust, unbiased evidence on Trushield NXT over SOC in routine practice.

The primary objective of the study was to evaluate the effectiveness of Trushield NXT non adherent wound dressing over the standard of care dressing in postoperative wound management of obstetric and gynaecological surgeries. The secondary objectives include evaluation of the pain scores via a Visual Analog Scale (VAS) as well as the comfort and ease, cosmetic appearance of the wound using a modified Hollander wound score scale (9), wound healing using photographs using Early Wound Healing Scale (EHS) (10), patient satisfaction on wound dressing and wound healing and evaluation of material problems and other Adverse Events (AE) among the two groups.

The aim of the present study was to compare the effectiveness of Trushield NXT non adherent wound dressing over SOC dressing (cotton+povidone+leucoplast) in postoperative wound management of obstetric and gynaecological surgeries. The exploratory objective of the present study was to evaluate different bacterial species in the wound site after the removal of first dressing.

Material and Methods

This was an investigator-initiated, single-centre, prospective, two-arm, parallel-group, randomised (1:1), study conducted in the Department of Obstetrics and Gynaecology, Institute of Post-Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial (IPGMER and SSKM) Hospital, between 7th Feb 2022 and 18th May 2022. The study was approved by the Institutional Ethics Committee. Prior to randomisation, written informed consent was obtained from every subject who participated in the study. The study was conducted in accordance with the Declaration of Helsinki and prospectively registered on 21/12/2021 in the Clinical Trial Registry of India with Ref No. CTRI/2021/12/038800. The study findings are reported as per Consolidated Standards of Reporting Trials (CONSORT).

A total of 114 women were screened between 7th Feb, 2022 and 31st March 2022, and were randomly assigned to two groups Trushield NXT and SOC arm. Three women were excluded from the study due to the appearance of exclusion criteria postconsenting and they did not receive any study intervention. The follow-up of the last recruited subject was completed on 18th May, 2022. Hence, 111 subjects were randomised into two groups; 56 subjects in Trushield NXT arm and 55 subjects in SOC (Table/Fig 1).

Inclusion criteria: Women aged 18-65 years undergoing uncomplicated obstetric and gynaecological surgeries {caesarean section (n=107)/hysterectomy (n=4)}, with haemoglobin more than/equal to 7 gm/dL, and ready to provide written informed consent were included in the study.

Exclusion criteria: Women based on the presence of condition/comorbidity that could compromise wound healing, including varicose eczema, peripheral vascular disease, receiving immunosuppressive medications, corticosteroid abuse, and having uncontrolled diabetes, a systemic infection not controlled by suitable antibiotic treatment, an active neoplastic condition, being treated by radiotherapy, chemotherapy, hormone therapy or immunosuppressant agents, treated for a chronic disease requiring high doses of systemic corticosteroids (≥40 mg/day of prednisolone or equivalent), a severe illness that might lead to premature withdrawal from the trial, or women participating in another clinical trial less than 30 days before participation in this trial or based on Investigator’s discretion were excluded from the study.

Sample size calculation: In a study, hydro fibre dressing was found to be 5.8 times more effective than traditional dressing with an adhesive border (11). Based on this evidence, superiority trial sample size calculation formula was used for the study with a power of 80%, and two-sided α of 0.1, and the sample size was estimated to be 94. Considering randomisation failure and loss to follow-up of 20%, sample size was increased to 114 with 57 subjects in each group.

Study Procedure

Trushield NXT non adherent wound dressing (Intervention group): 3-D Spacer fabric made of PET (90% w/w) and Polyurethane (10% w/w)+1% w/w of DTAC; Dimethyl Tetradecyl {3-(trimethoxysilyl) propyl} ammonium chloride (non leaching, permanently bound). The DTAC enables infection control by continuously inhibiting the growth of pathogens without depletion of the kill mechanism (without a decrease in the quantity of DTAC), since DTAC is permanently bound to the dressing fabric without leaching out in the skin or out of the dressing (8).

Mechanism of action: Trushield NXT non adherent wound dressing consists of cationic sites bound to it permanently. The cationic sites are present in all directions and attract negatively charged pathogens. The cationic sites attract pathogen cells and bind rapidly to the cellular envelope and physically disrupt the cell wall structures. This leads to lysis and disruption of cells leading to the killing of pathogens (7),(8),(12).

Standard of care dressing (Comparator group): Dressing used in SOC group is povidone-iodine solution, cotton gauze pad and a leucoplast adhesive pad to secure the cotton gauze pad.

All subjects who participated in the study underwent designated surgeries as per the standard institutional practice. After skin closure, either Trushield NXT or SOC dressing was used as per the randomisation. Randomisation was done to avoid bias while assigning the dressings. Initially, the patient was blinded as they came to know about the type of dressing used postsurgery only. The dressing was changed on day 3 as per hospital practice.

Randomisation

All women who participated in the study were randomly assigned in a 1:1 ratio to either Trushield NXT non adherent dressing or SOC dressing. The randomisation sequence was created independently using computer-generated randomisation (blocks of 4,6 and 8 was used). The randomisation code and the study arm details were concealed in opaque envelope which was opened on Day 0 when the patients were taken to the operation theatre for surgery.

Study Endpoints

Primary endpoints: The primary endpoints for the study were dressing application time, the number of dressing change, and evaluation of SSI using the Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and stay as an inpatient prolonged over 14 days (ASEPSIS) scoring system on day 3±1, day 8±1 and day 42±7. The score is calculated based on the percentage of the wound affected by serous exudate (0-5), erythema (0-5), purulent exudate (0-5), and separation of deep tissues (0-5). If none of the mentioned daily wound characteristics is present in a wound, then the scores for all four parameters are zero. In case the proportion of wounds affected is 20% then the score is 1, 20-39% then the score is 2, and similarly, a score of 3, 4, and 5 respectively for 40-59%, 60-79%, and >80% proportion of wound affected. Additional ten points each are awarded for antibiotic treatment, debridement of the wound under general anaesthesia, and isolation of bacteria whereas five points each are awarded for drainage of pus under local anaesthesia and stay as an inpatient for prolonged over 14 days (13).

Secondary endpoints: The secondary endpoints included pain scores on the VAS on day 0, 3±1, day 8±1, day 42±7, pain during dressing removal, evaluation of ease of application, usage, removal of the dressings using a product usage assessment scale (with a score of 1 to 5, where a score of 5 being excellent, and a score of 1 being poor) (14). Cosmetic appearance assessed using modified Hollander wound score on day 8±1, day 42±7, evaluation of wound healing score on day 8 using wound photograph by an independent assessor on day 8±1 (15). Patient satisfaction of wound dressing and wound healing was assessed using 5 point scale on day 8±1, day 42±7. The end of study visit was conducted on day 42±7 where the patient’s vitals, pain score, ASEPSIS score, Modified Hollander score, patient satisfaction on wound healing were evaluated apart from clinical investigation of the wound. The scoring for modified Hollander score is given as zero (absence) or one (presence) for characteristics of the wound like step-off borders, contour irregularities, margin separation, edge inversion, excessive distortion, and overall appearance. A total score of zero is best and score 6 is worst. The exploratory endpoint was the comparison of the presence of different bacterial species in the wound swab collected from the wound site while first dressing change in both groups. Occurrence of any Adverse Effects (AE)/Serious Adverse Events (SAE) were also recorded.

The patient demographics, vitals, medical, surgical history, and physical examination data were recorded on the screening visit. Participants were interviewed for dressing removal and re-application on day 3 and day 8. A wound swab was collected for isolation of bacteria from the wound site on day 3. Also, an image of the stitch line was captured for all patients irrespective of study arm during dressing change for each patient on day 8, and later wound healing score was given for each photograph by a surgeon who is independent of the study. To secure an unbiased assessment of the wound healing score, the surgeon who evaluated the photographs was blinded to the treatment allocation. Patients of both arms were discharged from the hospital on day 8 after the removal of the dressing.

Statistical Analysis

Continuous variables were assessed using Student’s t-test or Mann-Whitney U test or Moses’ test for extreme reaction and results were given as mean, and standard deviation as appropriate. Categorical variables were assessed using Pearson’s Chi-square test. Calculations were performed with a confidence interval of 95% wherever applicable and a p-value ≤0.05 was considered statistically significant. All statistical analysis was performed using Statistical Package for the Social Sciences (SPSS) software version 28.0.

Results

Baseline demographics (age, weight and height) and vital characteristics (temperature, blood pressure, pulse rate and respiratory rate) were comparable between the two groups (Table/Fig 2).

Primary Endpoint Analysis

SSI using ASEPSIS score: Superficial serous discharge was observed in one patient (1.78%) of the Trushield NXT group whereas Standard of care dressing group reported 13 (23.6%) cases, among which one sample from Trushield NXT and two samples from SOC tested positive for the presence of a microorganism. The mean ASEPSIS score for Trushield NXT and SOC was 6.97±0.63 vs. 7.04±0.61 which was found to have statistically significant p-value <0.0001 via moses test for extreme reaction. Trushield NXT group has 21.4% of patients with ASEPSIS score of more than 10, while SOC had 27.3% of patients with score more than 10 (Table/Fig 3).

Time required for application of dressing: The mean time of dressing was 39.16 seconds vs 101.07 seconds in Trushield NXT and SOC, respectively (p-value <0.0001) (Table/Fig 4).

Number of dressing changes: Patients in both groups needed two dressing changes on day 3 and day 8, respectively postsurgery. Only four SOC patients needed three dressing changes on day 3, day 6 and day 9, respectively. The results were not statistically significant for the number of dressing changes (p-value=0.68). Trushield NXT outperformed SOC in the primary endpoint analysis parameters for SSI and dressing application time, and the values were statistically significant.

Secondary Endpoints Analysis

Intraoperative profile: A total of 107 of the 111 study participants had caesarean deliveries, three had hysterectomies, and one had a laparoscopic hysterectomy. All patients who were enrolled received spinal anaesthesia and antimicrobial prophylaxis, which are standard procedures at the site (p-value=1.00). No dressing related challenges were reported for dressings used in the study. As shown in (Table/Fig 4), Trushield NXT was discovered to be more stretchable and easier to apply than SOC.

Postoperative profile: The postoperative pain started between 2-3 hours postsurgery. The intensity of pain can be seen to decrease with each follow-up visit along with the number of analgesics used as represented in (Table/Fig 3). Wound healing score was 82.57±8.83 vs 73.36±7.56 in Trushield NXT and SOC, respectively with statistically significant p-value of <0.0001 by Mann-Whitney U Test (Table/Fig 5).

In case of usability assessment also Trushield NXT performed better than SOC as summarised in (Table/Fig 4). The patient’s comfort in application, usage and pain during removal are summarised in (Table/Fig 6). Trushield NXT was observed to have more comfort and less pain with statistically significant p-values. The average patient satisfaction score on wound healing was 3.71±0.52 in Trushield NXT arm and 3.34±0.70 in SOC arm (p-value <0.0001).

The average modified Hollander score was 0.07±0.29 vs 0.13±0.3 in Trushield NXT and SOC, respectively with p-value <0.0001 by Moses’ test of extreme reaction, once again establishing Trushield NXT to be more effective than SOC in postoperative wound healing, management and cosmesis. The details of dressing removal parameters with significant p-value indicating Trushield NXT to be superior to SOC. The pain during dressing removal was significantly less in Trushield NXT arm than that in SOC (Table/Fig 6).

Exploratory Endpoint Analysis

As a part of exploratory outcome bacterial analysis from wound swab was performed on day 3. Enterobacter cloacae, Acinetobacter baumanni and Proteus mirabillis organism was reported in swab collected from three patients, one in Trushield NXT arm and two in SOC arm. This result was not statistically significant (p-value=1.000 calculated using Mann-Whitney U Test). The number of adverse events reported in Trushield NXT group was 4 (Fever, cough, cold and headache) and that in SOC was 5 (Fever, cough, cold, headache and stomach infection). All adverse events reported were not related to the dressings used. There were no SAE reported during the study.

Discussion

For SSI prevention, early detection of risk factors like diabetes, obesity, and immunosuppression is beneficial whereas for management of SSI, it is suggested by CDC that the incision site should remain covered by sterile dressing for at least 24-48 hours postsurgery (16). National Institute for Health and Care Excellence (NICE) guidelines updates team reports that in obstetric and gynaecological surgeries wound complications account for 2-30% (17). Another study reports the clinical safety and effectiveness of new antimicrobial dressings designed to manage exudate, which shows a lower rate of infection when compared to that of SOC (18). An ongoing study assessing the effectiveness of Dialkyl Carbamoyl Chloride (DACC) coated dressing versus SOC (the dressing trial) considered ASEPSIS score <10 to be indicative of satisfactory wound healing while that between 10-21 indicates impaired wound healing (13). In the present randomised control trial, Trushield NXT had more percentage of patients with <10 ASEPSIS score than SOC, once again establishing the effectiveness of Trushield NXT over SOC. It was also noted that all patient’s wound was completely healed on Day 42±7 and their ASEPSIS and pain scores were calculated as 0.00.

The observed evidence of 1.78% vs 23.6% superficial serous discharge in Trushield NXT and SOC, respectively is similar to results (2.8% vs 9.8%) observed in a pilot study, efficacy and cost-effectiveness of DAAC dressing over standard surgical dressing in managing SSI in a randomised controlled trial conducted on cesarean delivery patients, which emphasises the need for advanced dressings to prevent and manage SSI in postsurgical wound management (19). The result of the present study also indicates the same.

A study on chlorhexidine containing antimicrobial bandage highlighted the importance of antimicrobial bandage for postoperative wound management which is in terms with the results shown by our study while comparing Trushield NXT and SOC (20). The patient satisfaction score analysis in the current study study shows Trushield NXT performed better than SOC (3.71 vs 3.24; p-value <0.0001) which matches with the findings of randomised control trial on antimicrobial dressings versus SOC dressing with a patient satisfaction score of 52 vs 49 (p-value=0.002), respectively in obese women undergoing caesarean delivery (21). Evidence from a meta-analysis suggests hydro fibre dressings have fewer wound complications which was also witnessed in the current study with a relatively lower number of SSI in Trushield NXT than that of SOC (22),(23).

The basic parameters for an effective postoperative wound healing like ASEPSIS score <10, application, usability and removal satisfaction from patient and provider along with less pain score, pain during removal and dressing time make Trushield NXT non adherent wound dressing a more potent choice of dressing than SOC in obstetric and gynaecological surgeries.

Limitation(s)

The study was performed in a single-centre with a relatively small patient population. If it was performed across different hospitals with varied settings and patient pools, the results would have been more enriching and generalisable. Also, the surgical procedures conducted are clean surgeries with less incidence of SSI.

Conclusion

In obstetric and gynaecological surgery, it was found that Trushield NXT non adherent wound dressing performed better in postoperative wound management than SOC with not only superior provider and patient satisfaction but also in wound healing, ASEPSIS score, and pain management.

Acknowledgement

The authors are grateful to Healthium Medtech Limited for providing the Trushield NXT dressings and funding in the form of educational grant for conducting the study.

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DOI and Others

DOI: 10.7860/JCDR/2022/59719.17350

Date of Submission: Aug 18, 2022
Date of Peer Review: Sep 19, 2022
Date of Acceptance: Oct 26, 2022
Date of Publishing: Dec 01, 2022

AUTHOR DECLARATION:
• Financial or Other Competing Interests: None
• Was Ethics Committee Approval obtained for this study? Yes
• Was informed consent obtained from the subjects involved in the study? Yes
• For any images presented appropriate consent has been obtained from the subjects. Yes

PLAGIARISM CHECKING METHODS:
• Plagiarism X-checker: Aug 25, 2022
• Manual Googling: Oct 13, 2022
• iThenticate Software: Oct 17, 2022 (11%)

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