Dermal Substitute and Topical Negative Pressure in Burns

NCT00548314 | Completed Phase 3 DMC

• 1 other identifier: 07.109
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Keywords

Matriderm; Dermal matrix; VAC therapy; Split skin graft; Burns; Scar quality

Outcome Measures

Primary Outcomes (1)

• skin elasticity parameters (representing scar quality)

  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)

  after 3 months

Study Arms (4)

1

EXPERIMENTAL

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.

Other: dermal matrix; Device: VAC therapy (KCI)

2

EXPERIMENTAL

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.

Other: dermal matrix

3

EXPERIMENTAL

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.

Device: VAC therapy (KCI)

4

ACTIVE COMPARATOR

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

Procedure: Split skin graft

Interventions

dermal matrix OTHER

1mm thickness matrix composed of collagen-elastin hydrolosate

Also known as: Matriderm

1; 2

Split skin graft PROCEDURE

4

VAC therapy (KCI) DEVICE

VAC therapy for 3-5 days 125mmHg

1; 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Association of Dutch Burn Centres: lead

Study Sites (1)

Red Cross Hospital

Beverwijk, North Holland, 1942 LE, Netherlands

Location

MeSH Terms

Conditions

Burns

Interventions

matriderm

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Esther Middelkoop, Professor

  Association of Dutch Burn Centres (ADBC)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 22, 2007
• First Posted: October 23, 2007
• Study Start: October 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: February 1, 2011
• Last Updated: March 24, 2011

Record last verified: 2011-03

Locations

NL (1)