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Acticoat Absorbent and BCT Antimicrobial for STSG Donor Site on Thigh

Primary Purpose

Wound Healing, Wound Infection, Pain

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Acticoat Absorbent
BCT
Sponsored by
Kaohsiung Veterans General Hospital.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wound Healing focused on measuring wound healing, wound infection, pain, pruritus, cicatrix, dressings, acticoat absorbent, BCT, KoCarbonAg

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaohsiung Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Acticoat Absorbent

BCT wound dressing

Arm Description

Acticoat Absorbent wound dressing

wound dressing

Outcomes

Primary Outcome Measures

wound healing rate
percentage of wound area that has healed at this time
wound infection rate
wound healing rate
percentage of wound area that has healed at this time

Secondary Outcome Measures

scar appearance
pain and itchiness
scar appearance
scar appearance
pain and itchiness
pain and itchiness
pain and itchiness
pain and itchiness
pain and itchiness
pain and itchiness

Full Information

First Posted
January 10, 2013
Last Updated
February 20, 2013
Sponsor
Kaohsiung Veterans General Hospital.
Collaborators
Bio-medical Carbon Technology Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01769144
Brief Title
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

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
April 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaohsiung Veterans General Hospital.
Collaborators
Bio-medical Carbon Technology Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Healing, Wound Infection, Pain, Pruritus, Cicatrix
Keywords
wound healing, wound infection, pain, pruritus, cicatrix, dressings, acticoat absorbent, BCT, KoCarbonAg

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acticoat Absorbent
Arm Type
Active Comparator
Arm Description
Acticoat Absorbent wound dressing
Arm Title
BCT wound dressing
Arm Type
Experimental
Arm Description
wound dressing
Intervention Type
Device
Intervention Name(s)
Acticoat Absorbent
Intervention Description
wound dressing
Intervention Type
Device
Intervention Name(s)
BCT
Other Intervention Name(s)
KoCarbonAg
Intervention Description
wound dressing
Primary Outcome Measure Information:
Title
wound healing rate
Description
percentage of wound area that has healed at this time
Time Frame
7 days
Title
wound infection rate
Time Frame
7 days
Title
wound healing rate
Description
percentage of wound area that has healed at this time
Time Frame
14 days
Secondary Outcome Measure Information:
Title
scar appearance
Time Frame
1 month
Title
pain and itchiness
Time Frame
1day
Title
scar appearance
Time Frame
3 months
Title
scar appearance
Time Frame
6 months
Title
pain and itchiness
Time Frame
2 days
Title
pain and itchiness
Time Frame
3 days
Title
pain and itchiness
Time Frame
4 days
Title
pain and itchiness
Time Frame
5 days
Title
pain and itchiness
Time Frame
6 days
Title
pain and itchiness
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kuei-Chang Hsu, MD
Phone
+886-7-3422121
Ext
3073
Email
kchsu@vghks.gov.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuei-Chang Hsu, MD
Organizational Affiliation
Kaohsiung Veterans General Hospital.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuei-Chang Hsu, MD
First Name & Middle Initial & Last Name & Degree
Kuei-Chang Hsu, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
10716354
Citation
Klasen HJ. Historical review of the use of silver in the treatment of burns. I. Early uses. Burns. 2000 Mar;26(2):117-30. doi: 10.1016/s0305-4179(99)00108-4. No abstract available.
Results Reference
background
PubMed Identifier
16531870
Citation
Trop M, Novak M, Rodl S, Hellbom B, Kroell W, Goessler W. Silver-coated dressing acticoat caused raised liver enzymes and argyria-like symptoms in burn patient. J Trauma. 2006 Mar;60(3):648-52. doi: 10.1097/01.ta.0000208126.22089.b6.
Results Reference
background
PubMed Identifier
17959313
Citation
Vlachou E, Chipp E, Shale E, Wilson YT, Papini R, Moiemen NS. The safety of nanocrystalline silver dressings on burns: a study of systemic silver absorption. Burns. 2007 Dec;33(8):979-85. doi: 10.1016/j.burns.2007.07.014. Epub 2007 Oct 23.
Results Reference
background
PubMed Identifier
9848045
Citation
Tredget EE, Shankowsky HA, Groeneveld A, Burrell R. A matched-pair, randomized study evaluating the efficacy and safety of Acticoat silver-coated dressing for the treatment of burn wounds. J Burn Care Rehabil. 1998 Nov-Dec;19(6):531-7. doi: 10.1097/00004630-199811000-00013.
Results Reference
result
PubMed Identifier
17901734
Citation
Argirova M, Hadjiski O, Victorova A. Acticoat versus Allevyn as a split-thickness skin graft donor-site dressing: a prospective comparative study. Ann Plast Surg. 2007 Oct;59(4):415-22. doi: 10.1097/SAP.0b013e3180312705.
Results Reference
result
PubMed Identifier
11525858
Citation
Innes ME, Umraw N, Fish JS, Gomez M, Cartotto RC. The use of silver coated dressings on donor site wounds: a prospective, controlled matched pair study. Burns. 2001 Sep;27(6):621-7. doi: 10.1016/s0305-4179(01)00015-8.
Results Reference
result
PubMed Identifier
17175106
Citation
Huang Y, Li X, Liao Z, Zhang G, Liu Q, Tang J, Peng Y, Liu X, Luo Q. A randomized comparative trial between Acticoat and SD-Ag in the treatment of residual burn wounds, including safety analysis. Burns. 2007 Mar;33(2):161-6. doi: 10.1016/j.burns.2006.06.020. Epub 2006 Dec 18.
Results Reference
result
PubMed Identifier
20961690
Citation
Moiemen NS, Shale E, Drysdale KJ, Smith G, Wilson YT, Papini R. Acticoat dressings and major burns: systemic silver absorption. Burns. 2011 Feb;37(1):27-35. doi: 10.1016/j.burns.2010.09.006. Epub 2010 Oct 18.
Results Reference
result

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Acticoat Absorbent and BCT Antimicrobial for STSG Donor Site on Thigh

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