Clinical Study on Silk Sericin Wound Dressing for Split-thickness Skin Graft Donor Sites Treatment
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01539980|
Recruitment Status : Completed
First Posted : February 28, 2012
Results First Posted : April 2, 2015
Last Update Posted : April 2, 2015
- Silk sericin wound dressing may reduce time for complete epithelialisation of split-thickness skin graft donor sites compared to Bactigras®.
- Silk sericin wound dressing may reduce pain level at split-thickness skin graft donor sites compared to Bactigras® .
- Silk sericin wound dressing may not cause split-thickness skin graft donor sites infection as compared to Bactigras®.
- Split-thickness skin graft donor sites which treat by silk sericin wound dressing may not cause significant adverse events.
|Condition or disease||Intervention/treatment||Phase|
|Late Complication From Skin Graft Infection of Skin Donor Site Impaired Wound Healing Pain, Intractable||Device: Sericin scaffold||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Clinical Efficacy of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||April 2014|
|Experimental: Sericin scaffold||
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
- Clinical Efficacy of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment [ Time Frame: Within 14 days after operation ]Time for complete epithalization is duration between finishing surgical procedure and the dressing spontaneously peeling off from donor sites without causing pain. The wounds completely close and without fluid leakage and are able to exposed to the environment without pain. This duration should not exceed than 14 days.
- Clinical Safety of Wound Dressing Containing Silk Sericin for Split-thickness Skin Graft Donor Site Treatment [ Time Frame: Within 14 days after operation ]Number of patients with infected wound
- Pain Levels of Wounds [ Time Frame: Within 14 days after operation ]Pain may occur on operation wounds. Visual analog scale is used by patients themselves for monitoring the pain level with 0 = no pain, 10 = worst possible pain.
- Proinflammatory Cytokines (IL) [ Time Frame: Within 14 days after operation ]The proinflammatory cytokines from wound exudate will be measured for predicting the inflammatory level. ELISA kit is used.
- Liver Enzyme (AST) [ Time Frame: Within 14 days after operation ]Large, open wound may absorb some materials from wound dressing. If those materials are toxic, liver enzyme (a major organ for elimination of any toxicities) will be increased.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01539980
|Bangkok, Thailand, 10330|