Effectiveness of polyphenols extracted from Moringa oleifera leaves in split-thickness skin graft donor site wound healing: a double-blind randomized control trial
Split-thickness skin graft donor site wound healing
Current interventions as of 01/04/2026: Perioperative asepsis and sterility of instruments will be ensured. Participants will receive antibiotic prophylaxis with ampicillin 2 g IV one hour before anesthesia. Under spinal anesthesia, a 0.25 mm split-thickness skin graft will be harvested from the donor site using a manual dermatome after povidone-iodine disinfection and sterile draping. Hemostasis will be achieved using gauze soaked in adrenaline diluted 1:100,000. The harvested graft will be immediately placed in sterile normal saline. Participants will be randomized into experimental or control groups. At the donor site, the experimental group will receive paraffin gauze impregnated with either the polyphenolic extract or the total extracts (aqueous and methanolic) of Moringa oleifera leaves. The control group will receive non-impregnated paraffin gauze. In both groups, a secondary occlusive absorbent dressing will be applied. The extract is applied to the surface of the gauze in contact with the wound bed. At the recipient site, the graft will be fixed with 4/0 Vicryl after wound bed preparation and hemostasis. A primary dressing of non-impregnated paraffin gauze, followed by a secondary occlusive absorbent dressing, will be applied. No postoperative antibiotics will be administered. All participants will receive standardized analgesia: tramadol 100 mg every 8 hours plus paracetamol 1 g administered 4 hours after tramadol during the first three postoperative days. Pain (Visual Analogue Scale, at rest and on movement) and donor site healing (time to complete re-epithelialization) will be assessed on days 3, 5, 7, 10, 14, 17, 21, and 28. Donor site dressings will be changed at each assessment after cleaning with sterile saline, and wound measurements and photographs will be recorded. _____ Previous interventions: The researchers will conduct a double-blind clinical trial during which neither the assessor of completeness of donor site wound epithelialization no
Current key inclusion criteria as of 01/04/2026: 1. Aged 18 to 45 years 2. Requiring split-thickness skin graft 3. Clinically stable 4. Consented to the study 5. Extent of the donor site wound is less than 10% of the body surface area 6. Ability to be followed up until postoperative day 28 _____ Previous key inclusion criteria: 1. Aged 5 to 45 years old 2. Requiring split-thickness skin graft 3. Clinically stable 4. Consented to the study 5. Extent of the donor site wound is less than 10% of the body surface area
Current key exclusion criteria as of 01/04/2026: 1. Mental illness 2. Patients staying less than 6 months in the city 3. History of hypersensitivity reaction to Moringa oleifera derivatives 4. Immunodeficiency state 5. Pregnancy 6. Age below 18 years or over 45 years 7. Patient suffering from condition that may interfere with wound healing: diabetes, renal or hepatic insufficiency, malignant tumor, hypoalbuminemia (serum albumin <4 g/dL), malnutrition, smoking 8. Does not wish to participate in the study 9. Clinical condition deteriorates during the study 10. Decided to stop participating in the study 11. Discontinuation of treatment 12. Death during the study _____ Previous key exclusion criteria: 1. Mental illness 2. Patients staying less than 6 months in the city 3. History of hypersensitivity reaction to Moringa oleifera derivatives 4. Immunodeficiency state 5. Pregnancy 6. Age below 5 years or over 45 years 7. Patient suffering from condition that may interfere with wound healing: diabetes, renal or hepatic insufficiency, malignant tumor, hypoalbuminemia (serum albumin <4 g/dL), malnutrition, smoking 8. Does not wish to participate in the study 9. Clinical condition deteriorates during the study 10. Decided to stop participating in the study 11. Discontinuation of treatment 12. Death during the study