Acticoat Absorbent and BCT Antimicrobial for STSG Donor Site on Thigh

Kaohsiung Veterans General Hospital

Status: Unknown

Conditions: Cicatrix; Wound Healing; Pain; Wound Infection; Pruritus

Treatments: Device: Acticoat Absorbent; Device: BCT

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01769144

VGHKS12-CT9-09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Acticoat Absorbent

Active Comparator group

Description:

Acticoat Absorbent wound dressing

Treatment:

Device: Acticoat Absorbent

BCT wound dressing

Experimental group

Description:

wound dressing

Treatment:

Device: BCT