Efficacy and Safety of Silk Fibroin With Bioactive Coating Layer Dressing
Condition: Late Complication From Skin Graft; Infection of Skin Donor Site; Impaired Wound Healing; Pain, Intractable
MeSH terms: Skin Diseases, Infectious; Pain, Intractable
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      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.
    

Detailed description: 
      1. To compare the healing times of the split-thickness skin graft donor site under wound
           dressing containing silk fibroin woven fabric with bioactive coating layer and medicated
           paraffin gauze dressing.

        2. To compare the patients' pain levels of the split-thickness skin graft donor site under
           wound dressing containing silk fibroin woven fabric with bioactive coating layer and
           medicated paraffin gauze dressing.

        3. To compare the chance of infections of the split-thickness skin graft donor site under
           wound dressing containing silk fibroin woven fabric with bioactive coating layer and
           medicated paraffin gauze dressing.

        4. To determine the complications with the use of wound dressing containing silk fibroin
           woven fabric with bioactive coating layer.
    

Intervention name(s): Silk fibroin with bioactive coating layer dressing; Bactigras wound dressing
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Silk fibroin with bioactive coating layer dressing; Wound healing; Skin graft donor