The Safety of a Novel Acellular Dermal Template as Treatment for Burns and Scars

Full Thickness Skin Defects Clinical Trial

Official title:

A Phase 1, Randomized, Multicentre Multinational Study to Evaluate the Safety and Feasibility of an Acellular Dermal Template Novomaix for the Treatment of Full Thickness Skin Defects in Human Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02164760
• Other study ID #: ESG-09-2012
• Secondary ID: NL42113.094.12
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: June 2016

Study information

• Verified date: February 2020
• Source: Association of Dutch Burn Centres
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study the safety and feasibility 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. We expect this treatment to be safe, and to provide better outcome regarding scar quality.

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. Adult patients with acute (burn) wounds (group 1) and scars (group 2) will be included in this study. This phase I study aims to investigate the safety and feasibility of the use of this dermal matrix, with regard to graft take, epithelialisation and complications after transplantation. Moreover, scar quality will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years

1. with acute burns/trauma wounds that require skin grafting (group 1) OR

2. with scar problems requiring surgical treatment (group 2)

• Full thickness skin defects of 50 cm2 or more, but <50% TBSA

• Skin defects must be configured in such a way that two areas of 25 cm2 can be grafted

• Informed consent by the patient

Exclusion Criteria:

• Patients with infected wounds

• Pregnant or breast feeding females

• Patients with known concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, HIV, diabetes, collagenoses, cancer)

• Known allergy against porcine collagen or elastin

• Patients who are expected (according to the responsible medical doctor) to be noncompliant 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

Related Conditions & MeSH terms

• Full Thickness Skin Defects

Intervention

Device:
• Novomaix dermal substitute in combination with STSG
Novomaix dermal substitute in combination with STSG

Locations

Country	Name	City	State
Germany	Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie	Berlin
Netherlands	Red Cross Hospital	Beverwijk	Noord-Holland

Sponsors (3)

Lead Sponsor	Collaborator
Association of Dutch Burn Centres	Ernst Reichmann Tissue Biology Research Unit, Zürich, Seventh Framework Programme

Countries where clinical trial is conducted

Germany,  Netherlands, 

References & Publications (1)

Boekema BK, Vlig M, Olde Damink L, Middelkoop E, Eummelen L, Bühren AV, Ulrich MM. Effect of pore size and cross-linking of a novel collagen-elastin dermal substitute on wound healing. J Mater Sci Mater Med. 2014 Feb;25(2):423-33. doi: 10.1007/s10856-013-5075-2. Epub 2013 Nov 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft take (experimental vs control area)	Subjective assessment of two experienced observers	5-7 days postoperative
Secondary	Epithelialization	Subjective assessment of two experienced observers	5-7 and 18 ± 2 days days postoperative
Secondary	Complication rate	Measurement of re-operations, infection rate by culture swabs	Up to 12 months postoperative
Secondary	Scar quality	As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale	3 months
Secondary	Scar quality	As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale	6 months
Secondary	Scar quality	As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale	9 months
Secondary	Scar quality	As measured scar elasticity, scar colour and pigmentation, and a subjective scar assessment scale	12 months