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COMPLETED
NCT06787924
NA

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

Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt

View on ClinicalTrials.gov

Summary

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.

Official title: Effect of a Preoperative Oral Collagen-Based Formulation on Dermal Collagen Content, Wound Outcomes, and Scar Quality in Post-Bariatric Body-Contouring Surgery: A Randomized, Placebo-Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

111

Start Date

2025-04-15

Completion Date

2026-05-20

Last Updated

2026-09-28

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Collagen hydrolyzed peptides

Collagen-based oral powder containing hydrolyzed bovine collagen peptides, vitamin C derived from acerola, and hyaluronic acid.

DIETARY_SUPPLEMENT

Starch

Food-grade starch in matched opaque sachets.

Locations (1)

Facility Name: The department of plastic and reconstructive surgery, Medical Research Institute Hospital, Alexandria University, Alexandria, Egypt

Alexandria, Egypt