Dermal Substitute and Topical Negative Pressure in Burns - Full Text View

Sponsor:	Association of Dutch Burn Centres
Collaborator:	no collaborators
Information provided by:	Association of Dutch Burn Centres
ClinicalTrials.gov Identifier:	NCT00548314

Purpose

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.

Condition	Intervention	Phase
Burns	Other: dermal matrix Procedure: Split skin graft Device: VAC therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Application of a Dermal Substitute and Topical Negative Pressure to Improve the Healing of Burn Wounds

Resource links provided by NLM:

MedlinePlus related topics: Burns Scars

U.S. FDA Resources

Further study details as provided by Association of Dutch Burn Centres:

Primary Outcome Measures:

skin elasticity parameters (representing scar quality) [ Time Frame: after 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	72
Study Start Date:	October 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental the selected wound will be treated with dermal substitute Matriderm, split skin graft (SSG) and VAC therapy	Other: dermal matrix 1mm thickness matrix composed of collagen-elastin hydrolosate Device: VAC therapy VAC therapy for 3-5 days 125mmHg
2: Experimental the selected wound will be treated with dermal substitute Matriderm, and split skin graft	Other: dermal matrix 1mm thickness matrix composed of collagen-elastin hydrolosate
3: Experimental the selected wound will be treated with split skin graft and VAC therapy	Device: VAC therapy VAC therapy for 3-5 days 125mmHg
4: Active Comparator the selected wound will be treated with split skin graft.	Procedure: Split skin graft -

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00548314

Contacts

Contact: Monica Bloemen, MD

0031251625291

mbloemen@rkz.nl

Locations

Netherlands, Noord-Holland
Red Cross Hospital	Recruiting
Beverwijk, Noord-Holland, Netherlands, 1942 LE
Contact: Monica Bloemen, MD 0031251265291 mbloemen@rkz.nl
Principal Investigator: Monica Bloemen, MD

Sponsors and Collaborators

Association of Dutch Burn Centres

no collaborators

Investigators

Study Director:

Esther Middelkoop, Professor

Association of Dutch Burn Centres (ADBC)

More Information

No publications provided

Responsible Party:	Association of Dutch Burn Centres ( Association of Dutch Burn Centres )
Study ID Numbers:	07.109
Study First Received:	October 22, 2007
Last Updated:	July 31, 2009
ClinicalTrials.gov Identifier:	NCT00548314 History of Changes
Health Authority:	Netherlands: Medical Ethics Review Committee (METC); Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Association of Dutch Burn Centres:

Matriderm
Dermal matrix
VAC therapy

Split skin graft
Burns
Scar quality

Additional relevant MeSH terms:

Burns
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on November 25, 2009