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

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

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-06-30

Brief Summary

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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.

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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. 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.

Conditions

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Full Thickness Skin Defects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No