Acticoat Absorbent and BCT Antimicrobial for STSG Donor Site on Thigh---A Randomised Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- wound infection rate
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Acticoat Absorbent
Acticoat Absorbent wound dressing
Intervention: Acticoat Absorbent (Device)
BCT wound dressing
wound dressing
Intervention: BCT (Device)
Outcomes
Primary Outcomes
wound infection rate
Time Frame: 7 days
wound healing rate
Time Frame: 14 days
percentage of wound area that has healed at this time
Secondary Outcomes
- scar appearance(6 months)
- pain and itchiness(7 days)
Investigators
Kuei-Chang Hsu
Consultant Surgeon
Kaohsiung Veterans General Hospital.