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

Primary Purpose

Burns

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
dermal matrix
Split skin graft
VAC therapy (KCI)
Sponsored by
Association of Dutch Burn Centres
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns focused on measuring Matriderm, Dermal matrix, VAC therapy, Split skin graft, Burns, Scar quality

Eligibility Criteria

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

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).

Sites / Locations

  • Red Cross Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

4

Arm Description

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.

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.

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.

After excision and adequate hemostasis, the selected wound will be treated with a split skin graft (SSG), mesh 1:1.5.

Outcomes

Primary Outcome Measures

skin elasticity parameters (representing scar quality)

Secondary Outcome Measures

take of graft after 5-7 days, time to complete (>95%) healing, scar assessment scale and scar colour/ pigmentation (Dermaspectrometer)

Full Information

First Posted
October 22, 2007
Last Updated
March 23, 2011
Sponsor
Association of Dutch Burn Centres
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1. Study Identification

Unique Protocol Identification Number
NCT00548314
Brief Title
Dermal Substitute and Topical Negative Pressure in Burns
Acronym
VAC-M
Official Title
Application of a Dermal Substitute and Topical Negative Pressure to Improve the Healing of Burn Wounds
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Association of Dutch Burn Centres

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
Matriderm, Dermal matrix, VAC therapy, Split skin graft, Burns, Scar quality

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Arm Title
3
Arm Type
Experimental
Arm Description
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.
Arm Title
4
Arm Type
Active Comparator
Arm Description
After excision and adequate hemostasis, the selected wound will be treated with a split skin graft (SSG), mesh 1:1.5.
Intervention Type
Other
Intervention Name(s)
dermal matrix
Other Intervention Name(s)
Matriderm
Intervention Description
1mm thickness matrix composed of collagen-elastin hydrolosate
Intervention Type
Procedure
Intervention Name(s)
Split skin graft
Intervention Type
Device
Intervention Name(s)
VAC therapy (KCI)
Intervention Description
VAC therapy for 3-5 days 125mmHg
Primary Outcome Measure Information:
Title
skin elasticity parameters (representing scar quality)
Time Frame
after 3 months
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esther Middelkoop, Professor
Organizational Affiliation
Association of Dutch Burn Centres (ADBC)
Official's Role
Study Director
Facility Information:
Facility Name
Red Cross Hospital
City
Beverwijk
State/Province
Noord-Holland
ZIP/Postal Code
1942 LE
Country
Netherlands

12. IPD Sharing Statement

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Dermal Substitute and Topical Negative Pressure in Burns

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