Clinical Evaluation of the Efficacy and Tolerability of Fitostimoline Plus Gauze and Spray vs Gold Standards in Post-Bariatric Surgery. Multicentric Randomized Controlled Pilot Study

Background: Bariatric surgery, while highly effective for severe obesity, frequently leads to significant excess skin, necessitating reconstructive plastic surgery (body contouring). Post-operative complications, including prolonged wound healing, infection, and suboptimal scarring, are common due to factors like chronic inflammation and extensive surgical sites. Effective wound management is crucial for favorable outcomes. Fitostimoline® Plus, a product known for its soothing and regenerative properties, offers a promising therapeutic option to promote tissue repair. Objective:This multicentric randomized controlled pilot study aimed to evaluate the efficacy and tolerability of Fitostimoline® Plus gauze and spray compared to a gold standard (non-adherent vaseline gauze) in promoting rapid wound healing, reducing infection risk, and enhancing scar quality in patients undergoing post-bariatric body contouring surgery. Methods:Conducted across three clinical centers, patients were sequentially assigned to either Fitostimoline® Plus (gauze and peri-lesional spray on the right side of the wound) or the control (vaseline gauze on the left side). Key parameters including wound healing progression, inflammatory response, skin condition, and complication rates (e.g., dehiscence, infection, hypertrophic scarring) were assessed at 7,15,30, and 90 days post-surgery. Statistical analysis compared outcomes between the two treatment sides. Results:Preliminary findings indicate significantly faster wound healing, reduced inflammation (redness, swelling), and improved skin elasticity on the Fitostimoline® Plus treated sides compared to the control. The incidence of complications such as infection and hypertrophic scarring was notably lower in the Fitostimoline® Plus group. No significant adverse effects related to Fitostimoline® Plus were observed. Conclusion: Fitostimoline® Plus demonstrates significant positive effects on post-surgical wound healing in bariatric patients, improving tissue recovery, reducing inflammation, and potentially lowering complication rates. These findings support its beneficial role as an adjunct in complex post-bariatric surgery patient care. Further large-scale studies are warranted to confirm these preliminary results.