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Clinical Study on Silk Sericin Wound Dressing for Split-thickness Skin Graft Donor Sites Treatment

NCT01539980 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-04-02

Study results available
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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.

Conditions

  • Late Complication From Skin Graft
  • Infection of Skin Donor Site
  • Impaired Wound Healing
  • Pain, Intractable

Interventions

DEVICE

Sericin scaffold

Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith\&Nephew, London, UK) are applied on the other half of the skin graft donor site

Sponsors & Collaborators

  • Chulalongkorn University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-03-31
Completion
2014-04-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01539980 on ClinicalTrials.gov