To examine the efficacy and safety of sericin dressing with collagen in STSG donor site
      treatment comparing with Bactigras®. Around 30 patients will be enrolled in this study.

Clinical Efficacy of Silk Sericin Dressing With Collagen for Split-thickness Skin Graft Donor Site Treatment

Wound Heal

Wound Surgical

Donor Site Complication

Wounds are a public health problem found worldwide that associated with both clinical and
      economic burdens. Although several wound dressings are available, some limitations of those
      dressings still existed resulting in the need for new wound dressing development.

      The sericin dressing with collagen was developed to provide a moist environment and bioactive
      ingredients to the wound bed. To evaluate its efficacy and safety, the STSG donor sites of
      each patient will be divided into two equal areas. Each area will be randomly allocated into
      sericin dressing with collagen group or control group (Bactigras®). The outcomes will be
      collected to examine the efficacy and safety of sericin dressing with collagen in comparison
      with commercial dressing Bactigras®.

wound dressing application

The number of days since starting treatment until the primary dressing can spontaneously detach from wound with full re-epithelialization (at least 95% re-epithelialization) without any drainage.

Professor

Pain score evaluated by patient using visual analog scales (0-10)

The incidence of infection will be reported as "present" or "not present". Infection wound is wound which has purulent secretion or some of the inflammatory reactions (erythema, warmth, pain or tenderness, or induration) and has positive result from microbiological test.

Adverse effects on hepatic function, renal function, and other adverse effects resulted from dressing application will be reported as "present" or "not present".

Vancouver scar scale evaluated by clinician at 1, 3, and 6 months after complete wound healing

Patient scale of Patient and observer scar scale (POSAS) evaluated by patients 6 months after complete wound healing

Erythema level measured by using Mexameter® at 1, 3, and 6 months after complete wound healing

Melanin level measured by using Mexameter® at 1, 3, and 6 months after complete wound healing

TEWL measured by using Tewameter® at 1, 3, and 6 months after complete wound healing

Hydration level measured by using Corneometer® at 1, 3, and 6 months after complete wound healing

Elasticity parameters measured by using Cutometer® at 1, 3, and 6 months after complete wound healing

Clinical Efficacy of Silk Sericin Dressing With Collagen for Split-thickness Skin Graft Donor Site Treatment

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status