ABSTRACT
Background Oncological surgeries pose an elevated risk of surgical site infections (SSIs) due to their complexity and various associated treatments, impacting patient outcomes and healthcare costs. This has prompted a focus on advanced wound dressings that provide microbial protection, exudate absorption, and improved product performance, enhancing patient satisfaction. Our study aimed to compare the efficacy and safety of Theruptor NXT with the current standard of care (SOC) practice involving cotton/povidone/micropore dressings in the postoperative wound management of oncological surgeries. Methodology A total of 102 patients who underwent oncological surgeries in the Department of Surgical Oncology, Vydehi Institute of Medical Sciences and Research Centre, Bengaluru, India between May and September 2023 were randomized to Theruptor NXT and SOC dressing groups (51 patients each). The incidence of SSIs, wound pain score, cosmetic appearance of the wound, and adverse events were assessed in the two groups at various intervals, i.e., post-surgery day 2 ± 1, day of discharge, and post-surgery day 30 ± 7. Further, the subject satisfaction and product usage were evaluated on post-surgery day 2 ± 1. Results The baseline characteristics were found to be comparable in both groups, i.e., Theruptor NXT and SOC groups. Further, the SSI rates, scar outcomes, and physiological parameters were also similar between the Theruptor NXT and SOC groups, indicating a similar safety profile of both dressings (p > 0.05). However, the product usage assessment revealed statistically significant differences, favoring Theruptor NXT in terms of superior ease of application, stretchability, exudate management, breathability, and non-adherence properties (p < 0.05). Conclusions Our findings suggest that Theruptor NXT wound dressing is a promising, effective, and user-friendly alternative to SOC wound dressing in diverse clinical settings.
ABSTRACT
Introduction Incisional hernia is a common complication of midline laparotomy that may develop even after several years of surgery. Abdominal fascia closure with ideal suture material reduces the incidence of incisional hernia. This study compared the clinical equivalence of PD Synth (Healthium Medtech Limited) and PDS (Ethicon, Johnson & Johnson) slowly absorbed polydioxanone suture with respect to the occurrence of incisional hernia, following elective/emergency midline laparotomy. Methods Eighty-eight subjects undergoing elective/emergency midline laparotomy were randomized to PD Synth (n=45) and PDS (n=43) groups of this prospective, multicenter, randomized (1:1), single-blind, two-arm, parallel-group study (December 2020-May 2023). Primary endpoint was incidence of incisional hernia, occurring within six and 12 months of surgery. Secondary endpoints included incidence of fascial dehiscence, surgical site infection (SSI), suture sinus, seroma, hematoma, scar tenderness, and re-suturing, and evaluation of operative data, hospital stay, intra-operative suture handling, pain, time to return to normal day-to-day activities and work, overall patient satisfaction score, and adverse events. Results One subject in both PD Synth and PDS groups (p>0.05) developed incisional hernia at umbilicus 12 months post-laparotomy. In PDS group, one subject each had incidences of SSI on day 2, day 7, and one month, two subjects developed seroma on day seven, and one subject had readmission on one month; two subjects in PD Synth group developed superficial SSI (one month). Findings of other secondary endpoints were comparable between the groups. Conclusion Primary and secondary outcomes manifested that PD Synth and PDS slowly absorbed polydioxanone sutures are clinically equivalent, and can be used for abdominal fascial closure following midline laparotomy.
