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Effects of polyphenols extracted from Moringa oleifera leaves to heal split-thickness skin graft donor site wounds

Effectiveness of polyphenols extracted from Moringa oleifera leaves in split-thickness skin graft donor site wound healing: a double-blind randomized control trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17883369
Enrollment
122
Registered
2024-05-07
Start date
2025-11-03
Completion date
Unknown
Last updated
2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Split-thickness skin graft donor site wound healing Skin and Connective Tissue Diseases

Interventions

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 an

Sponsors

Université de Goma
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Current primary outcome(s) as of 01/04/2026: Mean time to complete wound epithelialization assessed using a sterile transparent plastic measuring guide from the Medline brand and the Bates-Jensen Wound Assessment Tool (BWAT) on Days 7, 10, 13, 16, 20, 24 and 28 _____ Previous primary outcome(s): Time to complete wound epithelialization assessed using a sterile transparent plastic measuring guide from the Medline brand and the Bates-Jensen Wound Assessment Tool (BWAT) on Days 7, 10, 13, 16, 20, 24 and 28

Secondary

MeasureTime frame
Current key secondary outcome(s) as of 01/04/2026: 1. Wound-related background pain measured using visual analogue scale (VAS) and the Wong-Baker Scale on days 3, 5, 7, 10, 14, 17, 21, and 28. 2. Rate of wound infection measured using culture and sensitivity of wound swab whenever clinical sign of infection is suspected _____ Previous key secondary outcome(s): 1. Wound-related background pain measured using visual analogue scale (VAS) and the Wong-Baker Scale on days 7, 10, 13, 16, 20, 24 and 28 2. Rate of wound infection measured using culture and sensitivity of wound swab whenever clinical sign of infection is suspected 3. Quality of scar measured using the Patient and Observer Scar Assessment Scale (POSAS) at day 28 4. The economic value of the dressing material measured using the Incremental Cost-Effectiveness Ratio (ICER) at complete wound epithelialization

Countries

Congo, Democratic Republic

Contacts

Public ContactTshimbila Kabangu
jmtkab@unigom.ac.cd+243 (0)976764798

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 17, 2026