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Acticoat Absorbent and BCT Antimicrobial for STSG Donor Site on Thigh

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ClinicalTrials.gov Identifier: NCT01769144
Recruitment Status : Unknown
Verified January 2013 by Kuei-Chang Hsu, Kaohsiung Veterans General Hospital..
Recruitment status was:  Recruiting
First Posted : January 16, 2013
Last Update Posted : February 21, 2013
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Wound Healing Wound Infection Pain Pruritus Cicatrix Device: Acticoat Absorbent Device: BCT

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acticoat Absorbent and BCT Antimicrobial for STSG Donor Site on Thigh---A Randomised Controlled Trial
Study Start Date : January 2013
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. wound healing rate [ Time Frame: 7 days ]
    percentage of wound area that has healed at this time

  2. wound infection rate [ Time Frame: 7 days ]
  3. wound healing rate [ Time Frame: 14 days ]
    percentage of wound area that has healed at this time

Secondary Outcome Measures :
  1. scar appearance [ Time Frame: 1 month ]
  2. pain and itchiness [ Time Frame: 1day ]
  3. scar appearance [ Time Frame: 3 months ]
  4. scar appearance [ Time Frame: 6 months ]
  5. pain and itchiness [ Time Frame: 2 days ]
  6. pain and itchiness [ Time Frame: 3 days ]
  7. pain and itchiness [ Time Frame: 4 days ]
  8. pain and itchiness [ Time Frame: 5 days ]
  9. pain and itchiness [ Time Frame: 6 days ]
  10. pain and itchiness [ Time Frame: 7 days ]

Eligibility Criteria

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01769144

Contact: Kuei-Chang Hsu, MD +886-7-3422121 ext 3073 kchsu@vghks.gov.tw

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.
Principal Investigator: Kuei-Chang Hsu, MD Kaohsiung Veterans General Hospital.
More Information

Additional Information:

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
First Posted: January 16, 2013    Key Record Dates
Last Update Posted: February 21, 2013
Last Verified: January 2013

Keywords provided by Kuei-Chang Hsu, Kaohsiung Veterans General Hospital.:
wound healing
wound infection
acticoat absorbent

Additional relevant MeSH terms:
Wounds and Injuries
Wound Infection
Skin Diseases
Skin Manifestations
Signs and Symptoms
Pathologic Processes
Anti-Infective Agents
Anti-Bacterial Agents