Clinical Research Directory

Effect of a Preoperative Oral Collagen-Based Formulation on Dermal Collagen Content, Wound Outcomes, and Scar Quality

This single-center, randomized, placebo-controlled trial evaluated whether approximately 8 weeks of preoperative supplementation with a 10-g daily collagen-based oral formulation affected dermal collagen content and postoperative outcomes in adults aged 18-65 years who had previously undergone metabolic/bariatric surgery and were scheduled for breast and/or abdominal body-contouring surgery. The active formulation contained hydrolyzed bovine collagen peptides, vitamin C from acerola, and hyaluronic acid; the comparator was 10 g of food-grade starch. Tissue was obtained only from skin routinely removed during the planned operation. The primary endpoint was dermal collagen area fraction measured in Picrosirius-red-stained excised skin. Secondary outcomes included collagen I and III immunohistochemical area fractions, epidermal thickness, TGF-β1 and MMP-1 expression, serum hydroxyproline, postoperative wound complications, and total Vancouver Scar Scale scores at 3 and 6 months. A total of 111 participants were randomized, 55 to the collagen-based formulation and 56 to placebo. Surgical and primary tissue assessments were completed on 15 December 2025, and final 6-month follow-up was completed on 20 May 2026.