Acticoat Absorbent and BCT Antimicrobial for STSG Donor Site on Thigh

Study Overview
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Brief Summary
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This study aims to compare the effectiveness of two wound dressings, Acticoat Absorbent (AA) and BCT Antimicrobial (BCT) on Split Thickness Skin Graft (STSG) donor site.

Detailed Description
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Seventy patients who undergo STSG procedure in Kaohsiung Veterans General Hospital will be recruited. Two donor sites of equal lengths and widths on the same thigh, which are at least 2 cm apart will be covered randomly with AA and BCT each. Wound healing rate and infection rate will be assessed at 7 and 14 days after surgery. Degrees of pain and itchiness will be assessed daily with Visual Analogue Scale for the first 7 post-operative days. Scar appearance will be assessed with Vancouver Scar Scale 1, 3 and 6 months post-operatively.

Official Title
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Acticoat Absorbent and BCT Antimicrobial for STSG Donor Site on Thigh---A Randomised Controlled Trial

Conditions
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Wound Healing, Wound Infection, Pain, Pruritus, Cicatrix

Intervention / Treatment
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* Device: Acticoat Absorbent
* Device: BCT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who need STSG, longer than 8 cm and wider than 5 cm, from their thighs Exclusion Criteria: systemic steroid old scar on thigh systemic infection anticipated use of antibiotics for more than 24 hours after operation pregnancy previous chemotherapy within 3 months before operation anticipated chemotherapy within 3 months after operation not over 20 years old non-communicable burn area more than 20% total body surface area systemic auto-immune disease liver cirrhosis allergy to carbon fiber or alginate anticipated MRI study dry wound

Ages Eligible for Study
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Minimum Age: 20 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acticoat Absorbent<br>Acticoat Absorbent wound dressing | Device: Acticoat Absorbent<br>* wound dressing<br>|
| Experimental: BCT wound dressing<br>wound dressing | Device: BCT<br>* wound dressing<br>* Other names: KoCarbonAg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound healing rate | percentage of wound area that has healed at this time | 7 days | 
| wound infection rate |  | 7 days | 
| wound healing rate | percentage of wound area that has healed at this time | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| scar appearance |  | 1 month | 
| pain and itchiness |  | 1day | 
| scar appearance |  | 3 months | 
| scar appearance |  | 6 months | 
| pain and itchiness |  | 2 days | 
| pain and itchiness |  | 3 days | 
| pain and itchiness |  | 4 days | 
| pain and itchiness |  | 5 days | 
| pain and itchiness |  | 6 days | 
| pain and itchiness |  | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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wound healing, wound infection, pain, pruritus, cicatrix, dressings, acticoat absorbent, BCT, KoCarbonAg