Bariatric Surgery, Abdominoplasty, Collagen Synthesis, Skin Physiology, Randomized Controlled Trial, Tissue Remodeling
Conditions
Keywords
bariatric surgery, collagen supplement, plastic surgery, abdominoplasty, skin, skin quality
Brief summary
This study aims to evaluate the effects of oral collagen supplementation on dermal collagen content in skin biopsies of patients undergoing abdominoplasty. Using a randomized controlled trial (RCT) design, participants from metabolic bariatric surgery (MBS) and plastic surgery groups will receive either collagen supplements or a placebo for several weeks. Biopsies will be collected pre-intervention and during surgery to compare collagen levels between groups and to baseline. The primary objective is to determine if collagen supplementation significantly enhances dermal collagen deposition compared to placebo and initial levels.
Interventions
DIETARY_SUPPLEMENTCollagen hydrolyzed peptides
bovine collagen peptides
DIETARY_SUPPLEMENTStarch
Starch placebo
Sponsors
General Committee of Teaching Hospitals and Institutes, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients aged 18-75 years after metabolic bariatric surgery. * Patients will be randomly selected from the hospital's electronic patient system.
Exclusion criteria
* 1\. Allergies or Sensitivities: * Patients with known allergies or hypersensitivity to collagen or any components of the collagen supplements (e.g., bovine, marine sources). 2\. 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. 3\. 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. 4\. 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. 5\. 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. 6\. Pregnancy or Lactation: * Pregnant or breastfeeding women should be excluded due to the physiological changes during pregnancy and lactation that could affect collagen metabolism. 7\. 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. 8\. Smoking: * Smokers or individuals who have recently quit smoking, as smoking is known to reduce collagen synthesis and impair skin healing. 9\. Chronic Illnesses: * Patients with chronic illnesses such as diabetes, liver disease, or kidney disease, which could impair collagen metabolism or affect skin health. 10\. 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. 11\. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Wound Healing Parameters vascularity | 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 | 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 | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Parameters hydroxyproline | biopsy during surgery | Total serum hydroxyproline, a marker of collagen degradation and turnover, will be measured in both the collagen supplement and placebo groups using the colorimetric method. This well-established technique provides accurate quantification of hydroxyproline levels, which will be used to infer collagen metabolism. Hydroxyproline levels will be compared between the groups using appropriate statistical tests to determine the impact of collagen supplementation on systemic collagen turnover. Potential confounding factors, such as dietary gelatin intake and conditions like hepatic fibrosis, which can influence hydroxyproline levels, will be carefully controlled for. These factors will be considered exclusion criteria to ensure the reliability of the serum hydroxyproline measurements |
Countries
Egypt
Contacts
PRINCIPAL_INVESTIGATORMohamed Hany Ashour, professor, MD
Alexandria University
Outcome results
None listed