Clinical trial NCT02373566: A Study to Evaluate the Efficacy of an Acellular Dermal Template for the Treatment of Full Thickness Skin Defects
Official title: 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
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: 2015-02-27
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: part of wound treated with /without dermal template
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Scar quality as assessed for scar elasticity (experimental vs control area) as measured by Cutometer or as assessed using subjective scar assessment scale (POSAS)
timeFrame: 3 months post-operative
Secondary outcomes:
measure: Graft take (Subjective assessment by experienced observer)
timeFrame: 5-7 days
measure: Epithelialisation (Subjective assessment by experienced observer)
timeFrame: 5-7 days and 2-3 weeks post-operative
measure: Scar quality (Scar elasticity as measured by Cutometer or as assessed using POSAS questionnaire)
timeFrame: 12 months
measure: Scar quality (As determined with subjective scar assessment scale (POSAS)
timeFrame: 3 and 12 months
measure: Scar quality (As measured for scar colour and pigmentation using DSM II ColorMeter)
timeFrame: 3 and 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
city: Zurich
country: Switzerland
facility: Children's Hospital Department of Surgery Kinderspital Zurich
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.