CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Sericin scaffolddevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01539980
NCT01539980Phase 2Completed

Clinical Efficacy of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment

Chulalongkorn University·interventional·Posted Feb 28, 2012·Updated Apr 2, 2015

In Brief

A Phase 2 clinical trial evaluating Sericin scaffold for Late Complication From Skin Graft and 3 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesThailand
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedFeb 28, 2012
Enrollment StartAug 1, 2012
Primary CompletionMar 1, 2014
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 14.3 years ago

Interventions

Sericin scaffolddevice

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