Clinical trial NCT02164760: The Safety of a Novel Acellular Dermal Template as Treatment for Burns and Scars
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Full Thickness Skin Defects
Keywords: burns
dermal substitute
scar quality
reconstruction
wound healing
wound closure
Lead sponsor: Association of Dutch Burn Centres
Sponsor class: OTHER
Collaborators: name: Ernst Reichmann Tissue Biology Research Unit, Zürich
name: Seventh Framework Programme
First posted: 2014-06-17
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Graft take (experimental vs control area)
timeFrame: 5-7 days postoperative
Secondary outcomes:
measure: Epithelialization
timeFrame: 5-7 and 18 ± 2 days days postoperative
measure: Complication rate
timeFrame: Up to 12 months postoperative
measure: Scar quality
timeFrame: 3 months
measure: Scar quality
timeFrame: 6 months
measure: Scar quality
timeFrame: 9 months
measure: Scar quality
timeFrame: 12 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Zentrum für Schwerbrandverletzte mit Plastischer Chirurgie
city: Beverwijk
country: Netherlands
facility: Red Cross Hospital
state: Noord-Holland
Study officials:
affiliation: Red Cross Hospital
name: Esther Middelkoop, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boekema BK, Vlig M, Olde Damink L, Middelkoop E, Eummelen L, Buhren 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.