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Dermal Substitute and Topical Negative Pressure in Burns (VAC-M)

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ClinicalTrials.gov Identifier: NCT00548314
Recruitment Status : Completed
First Posted : October 23, 2007
Last Update Posted : March 24, 2011
Sponsor:
Information provided by:
Association of Dutch Burn Centres

Tracking Information
First Submitted Date  ICMJE October 22, 2007
First Posted Date  ICMJE October 23, 2007
Last Update Posted Date March 24, 2011
Study Start Date  ICMJE October 2007
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2007)
skin elasticity parameters (representing scar quality) [ Time Frame: after 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00548314 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 22, 2007)
take of graft after 5-7 days, time to complete (>95%) healing, scar assessment scale and scar colour/ pigmentation (Dermaspectrometer) [ Time Frame: after 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dermal Substitute and Topical Negative Pressure in Burns
Official Title  ICMJE Application of a Dermal Substitute and Topical Negative Pressure to Improve the Healing of Burn Wounds
Brief Summary

The purpose of this study is to determine whether a treatment of full thickness wounds by the dermal substitute Matriderm, split skin graft and VAC treatment will improve scar quality, demonstrated by a significant increase of skin elasticity parameters after 3 months.

Additionally, an increase of the take of graft and improvement of scar assessment scale, scar colour/pigmentation and time to complete wound closure, is expected.

Detailed Description

The standard therapy for full thickness wounds is transplantation with a split thickness skin graft. However, scars usually develop as a result of this therapy. Previous research has demonstrated an improvement of scar quality if a dermal substitute was applied in combination with a split skin graft in reconstructive wounds, but not so much in burn wounds. One of the problems in burn wounds was the retarded outgrowth of the skin graft when a dermal substitute was applied in a one step procedure with the graft. Since then, application of topical negative pressure has demonstrated that the take and outgrowth of a skin graft can be improved by this technique. It now seems feasible to combine these two technologies in order to improve the quality of healing of burn wounds in the acute phase of healing.

Aim of the study is to investigate if application of a dermal substitute in combination with topical negative pressure can improve the quality of the scar in burn wounds.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Burns
Intervention  ICMJE
  • Other: dermal matrix
    1mm thickness matrix composed of collagen-elastin hydrolosate
    Other Name: Matriderm
  • Procedure: Split skin graft
  • Device: VAC therapy (KCI)
    VAC therapy for 3-5 days 125mmHg
Study Arms  ICMJE
  • Experimental: 1
    After excision and adequate hemostasis, the selected wound will be treated with the dermal substitute Matriderm, a split skin graft (SSG), mesh 1:1.5 and VAC therapy. The VAC system will be set at 125mmHg, continuous mode, for 3-5 days.
    Interventions:
    • Other: dermal matrix
    • Device: VAC therapy (KCI)
  • Experimental: 2
    After excision and adequate hemostasis, the selected wound will be treated with the dermal substitute Matriderm, a split skin graft (SSG), mesh 1:1.5.
    Intervention: Other: dermal matrix
  • Experimental: 3
    After excision and adequate hemostasis, the selected wound will be treated with a split skin graft (SSG), mesh 1:1.5 and VAC therapy. The VAC system will be set at 125mmHg, continuous mode, for 3-5 days.
    Intervention: Device: VAC therapy (KCI)
  • Active Comparator: 4
    After excision and adequate hemostasis, the selected wound will be treated with a split skin graft (SSG), mesh 1:1.5.
    Intervention: Procedure: Split skin graft
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 23, 2011)
86
Original Estimated Enrollment  ICMJE
 (submitted: October 22, 2007)
72
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients >=18 yrs with acute burns/trauma wounds that require skin grafting
  • Minimal study wound surface 10 cm2
  • Maximal study wound surface 300 cm2
  • Maximal TBSA 15% full thickness wounds
  • Informed consent

Exclusion Criteria:

  • Patients with wounds without adequate possibility to apply VAC
  • Immunocompromised patients
  • Infected wounds
  • Pregnant patients
  • Patients who are expected (according to the responsible medical doctor) to be non-compliant to the study protocol. This includes patients with severe cognitive dysfunction/impairment and severe psychiatric disorders (e.g. borderline or depression).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00548314
Other Study ID Numbers  ICMJE 07.109
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Association of Dutch Burn Centres
Study Sponsor  ICMJE Association of Dutch Burn Centres
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Esther Middelkoop, Professor Association of Dutch Burn Centres (ADBC)
PRS Account Association of Dutch Burn Centres
Verification Date March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP