Acticoat Absorbent and BCT Antimicrobial for STSG Donor Site on Thigh
This study is currently recruiting participants.
Verified January 2013 by Kaohsiung Veterans General Hospital.
Sponsor:
Kaohsiung Veterans General Hospital.
Collaborator:
Bio-medical Carbon Technology Co., Ltd.
Information provided by (Responsible Party):
Kuei-Chang Hsu, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier:
NCT01769144
First received: January 10, 2013
Last updated: February 20, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Wound Healing Wound Infection Pain Pruritus Cicatrix |
Device: Acticoat Absorbent Device: BCT |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Acticoat Absorbent and BCT Antimicrobial for STSG Donor Site on Thigh---A Randomised Controlled Trial |
Resource links provided by NLM:
Further study details as provided by Kaohsiung Veterans General Hospital.:
Primary Outcome Measures:
- wound healing rate [ Time Frame: 7 days ] [ Designated as safety issue: No ]percentage of wound area that has healed at this time
- wound infection rate [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
- wound healing rate [ Time Frame: 14 days ] [ Designated as safety issue: No ]percentage of wound area that has healed at this time
Secondary Outcome Measures:
- scar appearance [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- pain and itchiness [ Time Frame: 1day ] [ Designated as safety issue: No ]
- scar appearance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- scar appearance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- pain and itchiness [ Time Frame: 2 days ] [ Designated as safety issue: No ]
- pain and itchiness [ Time Frame: 3 days ] [ Designated as safety issue: No ]
- pain and itchiness [ Time Frame: 4 days ] [ Designated as safety issue: No ]
- pain and itchiness [ Time Frame: 5 days ] [ Designated as safety issue: No ]
- pain and itchiness [ Time Frame: 6 days ] [ Designated as safety issue: No ]
- pain and itchiness [ Time Frame: 7 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 70 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Acticoat Absorbent
Acticoat Absorbent wound dressing
|
Device: Acticoat Absorbent
wound dressing
|
|
Experimental: BCT wound dressing
wound dressing
|
Device: BCT
wound dressing
Other Name: KoCarbonAg
|
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| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769144
Contacts
| Contact: Kuei-Chang Hsu, MD | +886-7-3422121 ext 3073 | kchsu@vghks.gov.tw |
Locations
| Taiwan | |
| Kaohsiung Veterans General Hospital | Recruiting |
| Kaohsiung, Taiwan, 81362 | |
| Contact: Kuei-Chang Hsu, MD | |
| Principal Investigator: Kuei-Chang Hsu, MD | |
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Bio-medical Carbon Technology Co., Ltd.
Investigators
| Principal Investigator: | Kuei-Chang Hsu, MD | Kaohsiung Veterans General Hospital. |
More Information
Additional Information:
Publications:
| Responsible Party: | Kuei-Chang Hsu, Consultant Surgeon, Kaohsiung Veterans General Hospital. |
| ClinicalTrials.gov Identifier: | NCT01769144 History of Changes |
| Other Study ID Numbers: | VGHKS12-CT9-09 |
| Study First Received: | January 10, 2013 |
| Last Updated: | February 20, 2013 |
| Health Authority: | Taiwan : Food and Drug Administration |
Keywords provided by Kaohsiung Veterans General Hospital.:
|
wound healing wound infection pain pruritus cicatrix |
dressings acticoat absorbent BCT KoCarbonAg |
Additional relevant MeSH terms:
|
Pruritus Wound Infection Cicatrix Skin Diseases Skin Manifestations Signs and Symptoms Infection |
Wounds and Injuries Fibrosis Pathologic Processes Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013