Acticoat Absorbent and BCT Antimicrobial for STSG Donor Site on Thigh

NCT ID: NCT01769144

Last Updated: 2013-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-04-30

Brief Summary

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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

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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.

Conditions

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Wound Healing Wound Infection Pain Pruritus Cicatrix

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acticoat Absorbent

Acticoat Absorbent wound dressing

Group Type ACTIVE_COMPARATOR

Acticoat Absorbent

Intervention Type DEVICE

wound dressing

BCT wound dressing

wound dressing

Group Type EXPERIMENTAL

BCT

Intervention Type DEVICE

wound dressing

Interventions

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Acticoat Absorbent

wound dressing

Intervention Type DEVICE

BCT

wound dressing

Intervention Type DEVICE

Other Intervention Names

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KoCarbonAg

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bio-medical Carbon Technology Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Kaohsiung Veterans General Hospital.

OTHER

Sponsor Role lead

Responsible Party

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Kuei-Chang Hsu

Consultant Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kuei-Chang Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Veterans General Hospital.

Locations

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Kaohsiung Veterans General Hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Kuei-Chang Hsu, MD

Role: CONTACT

+886-7-3422121 ext. 3073

Facility Contacts

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Kuei-Chang Hsu, MD

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 10716354 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16531870 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17959313 (View on PubMed)

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.

Reference Type RESULT
PMID: 9848045 (View on PubMed)

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.

Reference Type RESULT
PMID: 17901734 (View on PubMed)

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.

Reference Type RESULT
PMID: 11525858 (View on PubMed)

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.

Reference Type RESULT
PMID: 17175106 (View on PubMed)

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.

Reference Type RESULT
PMID: 20961690 (View on PubMed)

Other Identifiers

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VGHKS12-CT9-09

Identifier Type: -

Identifier Source: org_study_id

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