Clinical trial NCT01769144: Acticoat Absorbent and BCT Antimicrobial for STSG Donor Site on Thigh
Official title: Acticoat Absorbent and BCT Antimicrobial for STSG Donor Site on Thigh---A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Wound Healing
Wound Infection
Pain
Pruritus
Cicatrix
Keywords: wound healing
wound infection
pain
pruritus
cicatrix
dressings
acticoat absorbent
BCT
KoCarbonAg
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
Collaborators: name: Bio-medical Carbon Technology Co., Ltd.
First posted: 2013-01-16
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: wound healing rate
timeFrame: 7 days
measure: wound infection rate
timeFrame: 7 days
measure: wound healing rate
timeFrame: 14 days
Secondary outcomes:
measure: scar appearance
timeFrame: 1 month
measure: pain and itchiness
timeFrame: 1day
measure: scar appearance
timeFrame: 3 months
measure: scar appearance
timeFrame: 6 months
measure: pain and itchiness
timeFrame: 2 days
measure: pain and itchiness
timeFrame: 3 days
measure: pain and itchiness
timeFrame: 4 days
measure: pain and itchiness
timeFrame: 5 days
measure: pain and itchiness
timeFrame: 6 days
measure: pain and itchiness
timeFrame: 7 days
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Kuei-Chang Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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