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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 111
- 试验地点
- 2
- 主要终点
- Dermal collagen area fraction in routinely excised skin
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18-65 years after metabolic bariatric surgery.
- •Patients will be randomly selected from the hospital's electronic patient system.
排除标准
- •Allergies or Sensitivities: Patients with known allergies or hypersensitivity to collagen or any components of the collagen supplements (e.g., bovine, marine sources).
- •Chronic Skin Conditions: Participants with skin disorders that could influence collagen production or degradation (e.g., psoriasis, eczema, scleroderma) should be excluded as these conditions might interfere with the study's outcomes.
- •Autoimmune or Connective Tissue Diseases: Patients with autoimmune diseases (e.g., lupus, rheumatoid arthritis) or connective tissue disorders (e.g., Ehlers-Danlos syndrome) might exhibit abnormal collagen metabolism and could confound the study's results.
- •Use of Collagen or Nutritional Supplements: Participants currently taking collagen supplements or other nutritional supplements (e.g., vitamin C, glucosamine, chondroitin) that could affect collagen synthesis or turnover should be excluded. A washout period may be required for those who have recently used such supplements.
- •Hormonal Treatments or Medications: Patients on treatments that could affect collagen metabolism (e.g., corticosteroids, hormone replacement therapy, anabolic steroids) should be excluded, as these could alter the body's collagen production or degradation.
- •Pregnancy or Lactation: Pregnant or breastfeeding women should be excluded due to the physiological changes during pregnancy and lactation that could affect collagen metabolism.
- •Major Surgeries or Trauma: Recent major surgeries or significant trauma within the last 6-12 months, especially those involving connective tissue repair, as these could alter collagen levels independently of supplementation.
- •Smoking: Smokers or individuals who have recently quit smoking, as smoking is known to reduce collagen synthesis and impair skin healing.
- •Chronic Illnesses: Patients with chronic illnesses such as diabetes, liver disease, or kidney disease, which could impair collagen metabolism or affect skin health.
- •Uncontrolled Metabolic Disorders: Participants with uncontrolled metabolic disorders (e.g., severe obesity, untreated hyperlipidemia) may have altered collagen metabolism and should be excluded unless specifically studied.
- •Participation in Other Clinical Trials: Patients currently enrolled in other clinical trials involving supplements, medications, or procedures that could interfere with the study outcomes should be excluded.
研究组 & 干预措施
Placebo (Food-grade starch)
Participants received 10 g of food-grade starch once daily in a pre-weighed opaque sachet dissolved in approximately 200 mL of water. The placebo contained negligible collagen. The placebo was packaged using the same opaque sachet format and dose weight as the active formulation.
干预措施: Starch (Dietary Supplement)
Collagen (Nutribites Collageen Naturel)
Participants received 10 g of the collagen-based formulation once daily in a pre-weighed sachet dissolved in approximately 200 mL of water. The formulation contained hydrolyzed bovine collagen peptides, vitamin C derived from acerola, and hyaluronic acid. Supplementation began 8 weeks before surgery; the recorded preoperative exposure was 56-59 days among participants with surgery. The trial tested the combined commercial formulation; the design does not permit attribution of the observed effects to collagen peptides alone.
干预措施: Collagen hydrolyzed peptides (Dietary Supplement)
结局指标
主要结局
Dermal collagen area fraction in routinely excised skin
时间窗: At the time of planned body-contouring surgery after approximately 8 weeks of preoperative supplementation; the recorded preoperative exposure was 56-59 days among participants with surgery.
The percentage of dermal area occupied by collagen in Picrosirius-red-stained sections from routinely excised breast and/or abdominal skin obtained during planned body-contouring surgery. Sections were examined using digital image analysis under polarized light according to predefined dermal regions of interest. The primary comparison was the adjusted between-group difference in dermal collagen area fraction between the collagen-based formulation and placebo groups.
Assessment of Wound Healing Parameters vascularity
时间窗: Biopsy during surgery
Wound healing will be evaluated using the single Vancouver Scar Scale (VSS), a validated tool for assessing scar quality. The VSS includes 1. vascularity with higher scores indicating more severe scar formation. This scale will allow for an objective evaluation of the appearance and functional quality of the wound healing in both the collagen supplement and placebo groups. The VSS has been widely used in clinical research for assessing scars in burn patients and offers a standardized approach to scar evaluation
Assessment of Wound Healing Parameters pigmentation
时间窗: Biopsy during surgery
Wound healing will be evaluated using the single Vancouver Scar Scale (VSS), a validated tool for assessing scar quality. The VSS includes 2. pigmentation, with higher scores indicating more severe scar formation. This scale will allow for an objective evaluation of the appearance and functional quality of the wound healing in both the collagen supplement and placebo groups. The VSS has been widely used in clinical research for assessing scars in burn patients and offers a standardized approach to scar evaluation
Assessment of Wound Healing Parameters thickness
时间窗: Biopsy during surgery
Wound healing will be evaluated using the single Vancouver Scar Scale (VSS), a validated tool for assessing scar quality. The VSS includes 3. thickness, with higher scores indicating more severe scar formation. This scale will allow for an objective evaluation of the appearance and functional quality of the wound healing in both the collagen supplement and placebo groups. The VSS has been widely used in clinical research for assessing scars in burn patients and offers a standardized approach to scar evaluation
Assessment of Wound Healing Parameters pliability
时间窗: Biopsy during surgery
Wound healing will be evaluated using the single Vancouver Scar Scale (VSS), a validated tool for assessing scar quality. The VSS includes 4. pliability with higher scores indicating more severe scar formation. This scale will allow for an objective evaluation of the appearance and functional quality of the wound healing in both the collagen supplement and placebo groups. The VSS has been widely used in clinical research for assessing scars in burn patients and offers a standardized approach to scar evaluation
次要结局
- Collagen I and collagen III area fractions(Baseline before supplementation and one day before planned body-contouring surgery, before surgical preparation.)
- Epidermal thickness(Baseline before supplementation and one day before planned body-contouring surgery, before surgical preparation.)
- TGF-β1 and MMP-1 expression(Baseline before supplementation and one day before planned body-contouring surgery, before surgical preparation.)
- Serum hydroxyproline(Baseline before supplementation and one day before planned body-contouring surgery, before surgical preparation.)
- Postoperative wound complications(assessed from the postoperative visit at approximately 2 weeks through the final follow-up.)
- Serum Parameters hydroxyproline(biopsy during surgery)
研究者
Mohamed Hany Ashour
Professor, surgeon
General Committee of Teaching Hospitals and Institutes, Egypt