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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Full Thickness Skin Defects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

part of wound treated with /without dermal template

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

participant and assessor are both unaware of location of dermal template

Study Groups

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Dermal substitute with STSG

Novomaix dermal substitute in combination with STSG

Group Type EXPERIMENTAL

Novomaix dermal substitute in combination with STSG

Intervention Type DEVICE

Novomaix dermal substitute in combination with STSG

STSG alone

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Novomaix dermal substitute in combination with STSG

Intervention Type DEVICE

Other Intervention Names

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Novomaix

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No