A Study to Evaluate the Efficacy of an Acellular Dermal Template for the Treatment of Full Thickness Skin Defects

Not Applicable

Completed

• Conditions: Full Thickness Skin Defects
• Interventions: Device: Novomaix dermal substitute in combination with STSG

• Registration Number: NCT02373566
• Lead Sponsor: Association of Dutch Burn Centres

Brief Summary

In this study the efficacy of an acellular dermal template (Novomaix), combined with split thickness skin grafts, for use in patients with full thickness skin defects, is tested. Results will be compared intra-patient with those obtained after conventional treatment with split thickness skin grafts. The investigators expect this treatment to provide better outcome regarding scar quality.

Detailed Description

Using dermal substitutes in combination with a split-thickness skin graft (STSG) is a well acknowledged therapy in burns and reconstructive surgery. Nevertheless, the ideal substitute is not available yet. We therefore want to investigate the use of an acellular dermal template (Novomaix), in combination with STSG, to treat these defects. Patients with with full thickness skin defects will be included in this study. This phase II study aims to investigate the efficacy of the use of this dermal matrix, with regard to scar quality as determined for elasticity at 3 months after treatment. Moreover, graft take (5-7 days after treatment), epithelialisation (5-7 days and 2-3 weeks), and scar quality (3 and 12 months after treatment, as determined for elasticity, colour/pigmentation, and using a subjective scar assessment scale) will be evaluated.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-02-23
• Study First Submitted QC: 2015-02-26
• Study First Posted: 2015-02-27
• Primary Completion: 2016-02
• Study Completion: 2016-09
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-13
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Age ≥18 years (for Zurich: ≤ 18 years)
• Full thickness skin defects configured in such a way that two comparable and measurable areas can be grafted, both of minimally 3x3 cm
• ≤ 50% TBSA full thickness skin defects at time of intervention
• Informed consent by the patient and/or legal representatives.

Exclusion Criteria

• Patients with infected wounds
• Full thickness skin wounds located in face and/or genitals will not be included
• Pregnant or breast feeding females
• Patients with known concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, HIV, uncontrolled diabetes, treatment with corticoid therapy, collagenoses, cancer)
• Known allergy against porcine collagen or elastin
• Patients that 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)
• Previous enrolment of the patient into the current study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dermal substitute with STSG	Novomaix dermal substitute in combination with STSG	Novomaix dermal substitute in combination with STSG

Primary Outcome Measures

Name	Time	Method
Scar quality as assessed for scar elasticity (experimental vs control area) as measured by Cutometer or as assessed using subjective scar assessment scale (POSAS)	3 months post-operative	Scar elasticity as measured by Cutometer or as assessed using subjective scar assessment scale (POSAS)

Secondary Outcome Measures

Name	Time	Method
Graft take (Subjective assessment by experienced observer)	5-7 days
Epithelialisation (Subjective assessment by experienced observer)	5-7 days and 2-3 weeks post-operative	Subjective assessment by experienced observer
Scar quality (Scar elasticity as measured by Cutometer or as assessed using POSAS questionnaire)	12 months	Scar elasticity as measured by Cutometer or as assessed using POSAS questionnaire
Scar quality (As determined with subjective scar assessment scale (POSAS)	3 and 12 months	As determined with subjective scar assessment scale (POSAS)
Scar quality (As measured for scar colour and pigmentation using DSM II ColorMeter)	3 and 12 months	As measured for scar colour and pigmentation using DSM II ColorMeter

Trial Locations

Locations (3)

Children's Hospital Department of Surgery Kinderspital Zurich; 🇨🇭 Zurich, Switzerland

Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie; 🇩🇪 Berlin, Germany

Red Cross Hospital; 🇳🇱 Beverwijk, Noord-Holland, Netherlands