Application of a dermal substitute and topical negative pressure to improve the healing of burn wounds

Phase 4

Completed

• Conditions: deep burns; full thickness burns; 10014982

• Registration Number: NL-OMON30864
• Lead Sponsor: Rode Kruis Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 72

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary end point: skin elasticity parameters (representing scar quality) after<br /><br>3 months </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary end points: take of graft after 5-7 days, scar assessment scale and<br /><br>scar colour/ pigmentation (Dermaspectrometer) after 3 months</p><br>