Acticoat Absorbent and BCT Antimicrobial for STSG Donor Site on Thigh

Not Applicable

• Conditions: Pain; Cicatrix; Wound Infection; Pruritus; Wound Healing
• Interventions: Device: Acticoat Absorbent; Device: BCT

• Registration Number: NCT01769144
• Lead Sponsor: Kaohsiung Veterans General Hospital.

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 Timeline

• Status Verified: 2013-01
• Study Start: 2013-01
• Study First Submitted: 2013-01-10
• Study First Submitted QC: 2013-01-14
• Study First Posted: 2013-01-16
• Last Update Submitted: 2013-02-20
• Last Update Posted: 2013-02-21
• Primary Completion: 2013-07
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acticoat Absorbent	Acticoat Absorbent	Acticoat Absorbent wound dressing
BCT wound dressing	BCT	wound dressing

Primary Outcome Measures

Name	Time	Method
wound infection rate	7 days
wound healing rate	14 days	percentage of wound area that has healed at this time

Secondary Outcome Measures

Name	Time	Method
scar appearance	6 months
pain and itchiness	7 days

Trial Locations

Locations (1)

Kaohsiung Veterans General Hospital; 🇨🇳 Kaohsiung, Taiwan