Facility Name: The surgical department of Medical Research Institute Hospital, Alexandria University, Alexandria, Facility
Alexandria, Egypt
NCT Number: NCT06787924
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.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Alexandria, Egypt
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
bovine collagen peptides
Starch placebo
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
General Committee of Teaching Hospitals and Institutes, Egypt
Other Gov
Effect of Collagen Supplements on Dermal Collagen Content Within Skin Biopsies of Plastic Surgery and Metabolic Bariatric Surgery Patients
Acronym: COLLAGEN
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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