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Completed

NCT Number: NCT00548314

Dermal Substitute and Topical Negative Pressure in Burns

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Red Cross Hospital

Beverwijk, North Holland, 1942 LE, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

dermal matrix

Other

1mm thickness matrix composed of collagen-elastin hydrolosate

Other names: Matriderm

Split skin graft

Procedure

VAC therapy (KCI)

Device

VAC therapy for 3-5 days 125mmHg

Primary outcomes

  1. skin elasticity parameters (representing scar quality)

    Time frame: after 3 months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Association of Dutch Burn Centres

Other

Registry information

Official study title

Application of a Dermal Substitute and Topical Negative Pressure to Improve the Healing of Burn Wounds

Acronym: VAC-M

Important dates

Study start
2007
Primary completion
2010
Study completion
2011
First posted
Oct 23, 2007
Registry last updated
Mar 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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