EuroSkinGraft - Novomaix phase II A phase 2, intra-patient randomised controlled multicentre international study to evaluate the efficacy of an acellular dermal template Novomaix for the treatment of full thickness skin defects.

Phase 2

Completed

• Conditions: Full thickness skin defects; scar problems; 10014982; 10040795

• Registration Number: NL-OMON41095
• Lead Sponsor: niversity of Zurich - Tissue Biology Research Unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

- Competent and temporarily incompetent patients age > = 18 years with full thickness skin defects that require skin grafting AND
- Full thickness skin defects configured in such a way that two comparable and measurable areas can be grafted, both of minimally 3x3 cm AND
- <= 50% TBSA (total body surface area) full thickness skin defects at time of intervention AND
- Informed consent by the patient and/or legal representatives.

Exclusion Criteria

When any of the following criteria are met, the potential subject will be excluded from participation in this study:
- 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: Not specified

Primary Outcome Measures

Name	Time	Method
<p>How does the scar quality skin elasticity obtained after full thickness wounds<br /><br>compare between wounds treated with Novomaix and STSG to those treated with<br /><br>STSG alone 3 months post surgery?</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- What is the initial graft take 5-7 days post-operative as determined by<br /><br>visual examination by an observer.<br /><br>- How does the progress of wound healing/ epithelialisation of the wounds<br /><br>compare between treatment with Novomaix plus STSG and STSG alone 5-7 days and<br /><br>2-3 weeks post-operative?<br /><br>- How does the scar quality obtained after full thickness wounds compare<br /><br>between wounds treated with Novomaix and STSG to that treated with STSG alone<br /><br>as determined by the scar assessment scale (POSAS) and the colour/pigmentation<br /><br>measurement (DSM II Dermaspectrometer) 3 and 12 months post-operative?<br /><br>- How does the scar quality obtained after full thickness wounds compare<br /><br>between wounds treated with Novomaix and STSG to those treated with STSG alone<br /><br>as determined by elasticity measurements (Cutometer®) 12 months post-operative?</p><br>