A Phase 1/2 interventional study of Silk fibroin with bioactive coating layer dressing and Bactigras wound dressing in Late Complication From Skin Graft, Infection of Skin Donor Site and Impaired Wound Healing, sponsored by Chulalongkorn University. Completed at 1 site in Thailand. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2016-11-03.
Sponsored by Chulalongkorn University · Phase 1/2, Interventional, and Treatment
A split-thickness skin graft (STSG) is used for a large wounds or wounds that cannot be closed by primary and secondary wound closure. Accelerated re-epithelialization rate and minimizing pain and infection are main goals of donor care. Traditionally dressings are inexpensive but adhere to the wound surface and cannot absorb exudates. Thus, we have developed a new biomaterial based on Thai silk for wound dressing application. Silk fibroin and silk sericin were selected to produce wound dressing in this study. The objective of this study is to compare wound dressing containing silk fibroin with bioactive coating layer with standard dressing (medicated paraffin gauze dressing; Bactigras®), with regard to healing time, patients' pain intensity, skin's transepidermal water loss after healing and evidence of infection in the treatment of split-thickness skin graft donor sites. The study design is a randomized, controlled, self paired clinical trial. Patients age 18 to 60 years and undergo STSG at thigh in Department of Surgery, King Chulalongkorn Memorial Hospital will be recruited in the study. The exclusion criteria are donor sites other than thigh area or located at high risk of infection. Patients who are immunocompromised or diabetes mellitus or psychiatric disorders or low serum albumin level (less than 3.0 g/dL) or known allergic to SS or SF or paraffin or chlorhexidine acetate are also excluded. All subjects sign the informed consents after discussion the protocol, benefits and risks. The donor site will be divided into two equal halves, each site will be randomized to receive the tested material or the medicated paraffin gauze dressing. The donor site wounds will be observed daily. The dressings will not be changed, except when they are fully soaked with exudates and easily fell off or any sign of infection. Healing time will be recorded when the dressing separate completely from the donor site, no exudates and no pain when the donor site is exposed to air. The patient's pain level will be evaluated with the visual analogue scale and the donor site wounds will be observed daily for signs of infection. On the day of the wound is recorded for healing time and 1 weeks, 1, 2, 3, 4 and 5 months after that, the skin barrier function (TEWL) of each site will be measured using a Tewameter. Blood sample will be collected from patients pre- and postoperatively (within day 3) for hepatic and renal function analysis.
86 studies on the registry are indexed under Skin Diseases, Infectious; 4 are open to participants now.
This study's enrollment of 29 is below the median of 161 across 74 interventional studies indexed under Skin Diseases, Infectious.
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Exclusion Criteria:
Silk fibroin coated with bioactive layer, apply once only
Device: Silk fibroin with bioactive coating layer dressing
Bactigras wound dressing, apply once only
Device: Bactigras wound dressing
Clinical efficacy of of wound dressing containing silk fibroin with bioactive coating layer dressing in the treatment of split-thickness skin graft donor sites
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.
Time frame: Within 14 days after operation
Clinical safety of wound dressing containing silk fibroin with bioactive coating layer dressing in the treatment of split-thickness skin graft donor sites
Percentage of wound infection
Time frame: Within 14 days after operation
Clinical safety of wound dressing containing silk fibroin with bioactive coating layer dressing in the treatment of split-thickness skin graft donor sites
Pain assessment is evaluated by patients themselves
Time frame: Within 14 days after operation
Clinical safety of wound dressing containing silk fibroin with bioactive coating layer dressing in the treatment of split-thickness skin graft donor sites
Laboratory measurement such as CBC, blood glucose, electrolyte, hepatic and renal function will be analyzed to find any changes or any systemic effect after treatment
Time frame: Within 14 days after operation
Clinical safety of wound dressing containing silk fibroin with bioactive coating layer dressing in the treatment of split-thickness skin graft donor sites
Transepidermal water loss (TEWL) measurement will be analyzed to find improvement in the rate of reestablishment of skin barrier function
Time frame: Within 14 days after operation
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Chulalongkorn University