Dermal Substitute and Topical Negative Pressure in Burns

NCT ID: NCT00548314

Last Updated: 2011-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2011-02-28

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.

Conditions

Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

dermal matrix

Intervention Type: OTHER

1mm thickness matrix composed of collagen-elastin hydrolosate

VAC therapy (KCI)

Intervention Type: DEVICE

VAC therapy for 3-5 days 125mmHg

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.

Group Type: EXPERIMENTAL

dermal matrix

Intervention Type: OTHER

1mm thickness matrix composed of collagen-elastin hydrolosate

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.

Group Type: EXPERIMENTAL

VAC therapy (KCI)

Intervention Type: DEVICE

VAC therapy for 3-5 days 125mmHg

4

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

Group Type: ACTIVE_COMPARATOR

Split skin graft

Intervention Type: PROCEDURE

Interventions

dermal matrix

1mm thickness matrix composed of collagen-elastin hydrolosate

Intervention Type: OTHER

Split skin graft

Intervention Type: PROCEDURE

VAC therapy (KCI)

VAC therapy for 3-5 days 125mmHg

Intervention Type: DEVICE

Other Intervention Names

Matriderm

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Association of Dutch Burn Centres

OTHER

Sponsor Role: lead

Responsible Party

Association of Dutch Burn Centres

Principal Investigators

Esther Middelkoop, Professor

Role: STUDY_DIRECTOR

Association of Dutch Burn Centres (ADBC)

Locations

Red Cross Hospital

Beverwijk, North Holland, Netherlands

Countries

Netherlands

Other Identifiers

07.109

Identifier Type: -

Identifier Source: org_study_id