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

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: 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.