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

Study Overview
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Brief Summary
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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.

Detailed Description
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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®.

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

Conditions
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Wound Heal, Wound Surgical, Donor Site Complication

Intervention / Treatment
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* Other: wound dressing application


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have STSG donor site wounds on the thigh area Age more than 18 years old The split-thickness skin graft is harvested for the first time at the investigated area. Patients who are able to communicate with the Thai language Willingness to participate Exclusion Criteria: Patient with a mental disorder or immunocompromised diseases Patients who cannot or not willing to follow the protocol Known sensitivity or allergy to sericin, chlorhexidine, and collagen Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sericin dressing with collagen<br>Sericin dressing with collagen | Other: wound dressing application<br>* Sericin dressing with collagen or Bactigras will be used as a primary dressing for treating the STSG donor site.<br>|
| Active Comparator: Bactigras<br>Commercial dressing | Other: wound dressing application<br>* Sericin dressing with collagen or Bactigras will be used as a primary dressing for treating the STSG donor site.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to complete healing | 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. | 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Pain score evaluated by patient using visual analog scales (0-10) | 42 days | 
| Incidence of infection | 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. | 42 days | 
| Incidence of adverse effect | Adverse effects on hepatic function, renal function, and other adverse effects resulted from dressing application will be reported as present or not present. | 42 days | 
| Vancouver scar scale (VSS) | Vancouver scar scale evaluated by clinician at 1, 3, and 6 months after complete wound healing | 6 months | 
| Patient scale of Patient and observer scar scale (POSAS) | Patient scale of Patient and observer scar scale (POSAS) evaluated by patients 6 months after complete wound healing | 6 months | 
| Erythema level | Erythema level measured by using Mexameter® at 1, 3, and 6 months after complete wound healing | 6 months | 
| Melanin level | Melanin level measured by using Mexameter® at 1, 3, and 6 months after complete wound healing | 6 months | 
| Trans-epidermal water loss (TEWL) | TEWL measured by using Tewameter® at 1, 3, and 6 months after complete wound healing | 6 months | 
| Skin hydration | Hydration level measured by using Corneometer® at 1, 3, and 6 months after complete wound healing | 6 months | 
| Skin elasticity | Elasticity parameters measured by using Cutometer® at 1, 3, and 6 months after complete wound healing | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wound dressing, Sericin, Collagen, Split-thickness skin graft donor site (STSG donor site)