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:
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
  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 April 17, 2014