Phase 2
N=30
Clinical Study on Silk Sericin Wound Dressing for Split-thickness Skin Graft Donor Sites Treatment
Late Complication From Skin Graft · Infection of Skin Donor Site · Impaired Wound Healing · Pain, Intractable
Bottom Line
View on ClinicalTrials.gov: NCT01539980 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Apr 2015
Primary outcome: Primary: Clinical Efficacy of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment — 12 Days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sericin scaffold (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Chulalongkorn University
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Efficacy of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment |
12 | — |
| SECONDARY Clinical Safety of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment |
— | — |
| SECONDARY Pain Levels of Wounds |
2.60 | — |
| SECONDARY Proinflammatory Cytokines (IL) |
31.65 | — |
| SECONDARY Liver Enzyme (AST) |
19 | — |
Summary
1. Silk sericin wound dressing may reduce time for complete epithelialisation of split-thickness skin graft donor sites compared to Bactigras®.
2. Silk sericin wound dressing may reduce pain level at split-thickness skin graft donor sites compared to Bactigras® .
3. Silk sericin wound dressing may not cause split-thickness skin graft donor sites infection as compared to Bactigras®.
4. Split-thickness skin graft donor sites which treat by silk sericin wound dressing may not cause significant adverse events.
Eligibility Criteria
Inclusion Criteria
- Aged 18-60 years
- Patients who require STSG such as burn, trauma, venous ulcers, or surgical removal of cutaneous malignancies etc.
- Patients whom surgeons assess that ready for undergoing STSG
- Sufficient normal skin at anterolateral thigh area for 1 or more STSG donor sites
- The thickness of donor sites fall between 0.15-0.45 mm (0.006-0.018 inches) and their sizes are at least 100 cm2
- Patients who are willing to participate in the trial and to sign the informed consent form.
Exclusion Criteria
- Use others area for STSG donor sites other than thigh
- Donor sites are located at high risk of infection such as harvesting closed to current infective wound (excessive purulent discharge or bad odor)
- Patients who are immunocompromised or mental defect
- Patients who cannot or not willing to comply with the study protocol
- Known allergy or hypersensitivity reaction to silk sericin or chlorhexidine acetate
- Pregnancy or lactation
Data sourced from ClinicalTrials.gov (NCT01539980). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.