NCT01769144

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 16, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

February 21, 2013

Status Verified

January 1, 2013

Enrollment Period

6 months

First QC Date

January 10, 2013

Last Update Submit

February 20, 2013

Conditions

Wound HealingWound InfectionPainPruritusCicatrix

Keywords

wound healingwound infectionpainprurituscicatrixdressingsacticoat absorbentBCTKoCarbonAg

Outcome Measures

Primary Outcomes (3)

  • wound healing rate

    percentage of wound area that has healed at this time

    7 days

  • wound infection rate

    7 days

  • wound healing rate

    percentage of wound area that has healed at this time

    14 days

Secondary Outcomes (10)

  • scar appearance

    1 month

  • pain and itchiness

    1day

  • scar appearance

    3 months

  • scar appearance

    6 months

  • pain and itchiness

    2 days

  • +5 more secondary outcomes

Study Arms (2)

Acticoat Absorbent

ACTIVE COMPARATOR

Acticoat Absorbent wound dressing

Device: Acticoat Absorbent

BCT wound dressing

EXPERIMENTAL

wound dressing

Device: BCT

Interventions

Acticoat AbsorbentDEVICE

wound dressing

Acticoat Absorbent
BCTDEVICE

wound dressing

Also known as: KoCarbonAg
BCT wound dressing

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who need STSG, longer than 8 cm and wider than 5 cm, from their thighs

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, 81362, Taiwan

RECRUITING

Related Publications (8)

  • 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.

    PMID: 10716354BACKGROUND

  • 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.

    PMID: 16531870BACKGROUND

  • 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.

    PMID: 17959313BACKGROUND

  • 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.

    PMID: 9848045RESULT

  • 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.

    PMID: 17901734RESULT

  • 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.

    PMID: 11525858RESULT

  • 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.

    PMID: 17175106RESULT

  • 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.

    PMID: 20961690RESULT

MeSH Terms

Conditions

Wound InfectionPainPruritusCicatrix

Condition Hierarchy (Ancestors)

InfectionsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSkin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsFibrosisPathologic Processes

Study Officials

  • Kuei-Chang Hsu, MD

    Kaohsiung Veterans General Hospital.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kuei-Chang Hsu, MD

CONTACT

+886-7-3422121kchsu@vghks.gov.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Surgeon

Study Record Dates

First Submitted

January 10, 2013

First Posted

January 16, 2013

Study Start

January 1, 2013

Primary Completion

July 1, 2013

Study Completion

April 1, 2014

Last Updated

February 21, 2013

Record last verified: 2013-01

Locations

TW(1)