Clinical Study on Silk Sericin Wound Dressing for Split-thickness Skin Graft Donor Sites Treatment
Condition: Late Complication From Skin Graft; Infection of Skin Donor Site; Impaired Wound Healing; Pain, Intractable
MeSH terms: Skin Diseases, Infectious; Pain, Intractable; Wounds and Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Detailed description: 
      Split-thickness skin graft (STSG) is a surgical procedure to repair losses of skin by
      transferring of a section of healthy skin (donor site) to replace the damaged tissue in
      another area of the body (recipient site). However, the patients will have a new wound at
      donor sites which need appropriate wound dressing to increase healing and reduce
      complications. Since silk sericin can form a dressing which can accelerate wound healing
      process and protect wound from environment, the aim of this study is to investigate how well
      silk sericin wound dressing cures STSG donor sites by comparing to Bactigras® which is a
      commonly used paraffin-impregnated fine mesh gauze. Silk sericin wound dressing is a
      promising material which can shorten the treatment course and reduce pain for the patients
      who have donor sites. This study design is a single-center, randomized, open and paralleled
      positive control study.18-60- year-old patients of both genders who undergo STSG at
      anterolateral thigh in Division of plastic and reconstructive surgery, King Chulalongkorn
      Memorial Hospital from April 2012 to January 2013 will be recruited in the study. 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. The exclusion criteria are donor sites other than thigh or located at high
      risk of infection. Patients who are immunocompromised or mental defect, who are unlikely to
      comply with protocol or pregnant or lactating or known hypersensitivity to the
      investigational products are also excluded. All subjects sign the informed consents after an
      overall discussion of the protocol, its rationale and the potential risks. Donor sites are
      equally divided into 2 parts; upper and lower part of the leg. Using a random number table
      allocation, silk sericin wound dressing is randomly applied on one half and the other half
      will be covered by Bactigras®. Postoperatively, surgeons will observe all donor sites daily
      for treatment evaluation and any possible local adverse events without removing the primary
      dressings, except there is excessive fluid leakage or any sign of infection. Patients assess
      for pain level in every observations by using Visual Analog Scale. Time for complete
      epithelialisation is duration between finishing surgical procedure and the dressing
      spontaneously peeling off from donor sites without causing pain. If there is any sign of
      infection such as swelling, edema, purulent discharge, bad odor, a swab evaluation at the
      suspected area will be done to find an appropriate management. Blood sample will be collected
      from patients pre- and postoperatively (with in 24h, day3 and before patient discharge) for
      CBC, blood glucose, electrolyte, hepatic and renal function analysis and proinflammatory
      cytokine measurement. This study may show any possible adverse events, both local and
      systemic effect, caused by silk sericin dressing. Proinflammatory cytokines patterns of the
      patients underwent STSG will be revealed in this study which may be relate to clinical
      outcomes.
    

Intervention name(s): Sericin scaffold
Intervention type(s): Device
Intervention description(s): 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
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Sericin scaffold; Wound healing; Skin graft donor