Efficacy, Safety, and Cost-Effectiveness of Healthium Theruptor Versus 3M Tegaderm Versus Plain Gauze Dressing for Wound Dressings Used in Abdominal and Joint Surgeries: A Prospective, Multicentric, Randomized Study

• Published in: Curēus (Palo Alto, CA) CA), 2024-02, Vol.16 (2), p.e53947-e53947
• Main Authors: Rodrigues, Michael, Varthya, Shoban, Sunderasan, Vinoth, Ganapathy, Tharun, Balan, Sakthi, Sivakumar, Gayathri, Badkur, Mayank, Gothwal, Meenakshi, Ambwani, Sneha, Charan, Jaykaran, Vadakaluru, Uthpala, Kumar Moharana, Ashok, Siddabasavaiah, Deepak
• Format: Article
• Language: English
• Subjects: Abdomen; Abdominal surgery; Bone surgery; Double-blind studies; General Surgery; Infections; Joint surgery; Medical dressings; Obstetrics/Gynecology; Orthopedics; Pain; Patient satisfaction; Skin; Wound dehiscence; Wound healing
• ISSN: 2168-8184; 2168-8184
• DOI: 10.7759/cureus.53947

Background In the realm of surgical and postoperative care, the application of wound dressings is a standard practice to facilitate healing, minimize infection risks, and offer a protective barrier against pathogens for optimal recovery. For instance, Theruptor is an active advanced wound care product with patented microbicidal technology. In the present study, we conducted a randomized clinical trial to compare the clinical efficacy and safety of Healthium Theruptor, 3M Tegaderm, and plain gauze dressings in patients undergoing abdominal and joint surgeries. Methodology This was a multicenter, prospective, three-arm, randomized, double-blind study conducted between April and November 2022 at three different sites in India, viz., All India Institute of Medical Sciences, Jodhpur; Mahatma Gandhi Medical College and Research Institute, Puducherry; and SRM Institute of Science and Technology, Chennai. A total of 210 patients were randomized to receive either of the following three interventions: Theruptor, Tegaderm, and plain gauze dressing (n = 70 each) based on computer-generated randomization sequences using sequentially numbered, opaque, sealed envelopes. Demographic data and surgery details were obtained and recorded at baseline. Parameters such as rate of wound healing, incidence of surgical site infections (SSIs), adverse events, product performance, and pain score were assessed and compared during the weekly follow-up visits until 28 days. In addition, wound assessments using the Stony Brook Scar evaluation scale, Cardiff Wound Impact Questionnaire, and Modified Hollander Wound Evaluation Scale were conducted to provide additional insights on the efficacy of the dressings (days 3, 7, 14, and 28). Lastly, the cost of wound management was assessed at the end of the study. The statistical analysis of the data was performed using a one-way analysis of variance followed by a Bonferroni post-hoc test on GraphPad software. Results All three dressings were equally effective in healing the wound and reducing the incidence of SSIs. The median healing time was estimated to be seven days. Further, no significant difference was observed in wound dehiscence, wound pain, clinical wound parameters, cosmetic assessment, and quality of life among the three groups (p > 0.05) during the follow-up visits. However, the product performance of Theruptor and Tegaderm was significantly better than plain gauze dressing in terms of ease of application (82.87% and 84.13% vs. 71.7%