To test an acellular dermal template (Novomaix) in human patients in need of full thickness skin defect coverage and to compare the results with those obtained after conventional STSG. The main goals are to study the efficacy and scar quality after…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
How does the scar quality skin elasticity obtained after full thickness wounds
compare between wounds treated with Novomaix and STSG to those treated with
STSG alone 3 months post surgery?
Secondary outcome
- What is the initial graft take 5-7 days post-operative as determined by
visual examination by an observer.
- How does the progress of wound healing/ epithelialisation of the wounds
compare between treatment with Novomaix plus STSG and STSG alone 5-7 days and
2-3 weeks post-operative?
- How does the scar quality obtained after full thickness wounds compare
between wounds treated with Novomaix and STSG to that treated with STSG alone
as determined by the scar assessment scale (POSAS) and the colour/pigmentation
measurement (DSM II Dermaspectrometer) 3 and 12 months post-operative?
- How does the scar quality obtained after full thickness wounds compare
between wounds treated with Novomaix and STSG to those treated with STSG alone
as determined by elasticity measurements (Cutometer®) 12 months post-operative?
Background summary
The functionally and cosmetically best therapeutic option for the treatment of
full thickness skin defects would be transplanting full thickness autologous
skin, as this basically leads to reconstruction of a perfectly normal skin in
terms of both function and cosmetics. However, donor site availability is
limited with respect to size and donor site morbidity, and the coverage of
extended lesions therefore still poses a very significant challenge. The
standard therapy for full thickness wounds is transplantation with a split
thickness skin graft (STSG). The surgical treatment with STSG often results in
disappointing scar quality. The use of a dermal substitute could improve
outcome of scars. The acellular dermal template Novomaix has been tested in a
pig model, and a phase I safety study has shown that also in humans use of this
material is safe. After our phase I study for safety outcome in humans, this
phase II study is the continuation to investigate the efficacy of Novomaix in
patients.
Study objective
To test an acellular dermal template (Novomaix) in human patients in need of
full thickness skin defect coverage and to compare the results with those
obtained after conventional STSG. The main goals are to study the efficacy and
scar quality after use of Novomaix in patients.
Study design
A randomized multinational intra-patient controlled clinical trial will be
conducted in one Dutch burn centre in Beverwijk, one German burn centre in
Berlin, and a Swiss burn centre in Zurich, all in collaboration with the
respective departments of plastic surgery or general surgery.
Intervention
In each patient a wound will be covered with Novomaix plus STSG and a
comparable wound will be covered with conventional STSG as control (standard)
treatment.
Study burden and risks
The burden for the patients participating in this study is minimal. The
components of treatment are added to the usual treatment for deep wounds that
these patients need to receive anyhow. Extra burden is represented by the fact
that the evaluation of the wounds and scars will take more time at follow-up,
and by the optional biopsies. This will take approximately 15-30 minutes more
than usual. A possible risk will be intolerance or an allergic reaction to one
of the substitute components. During the phase I safety study we observed no
relevant serious adverse events. The rationale behind this treatment is that it
will lead to improved scar quality with better cosmetic and functional
properties in time compared to conventional treatment. This might lead to a
reduced need for secondary reconstructive surgery.
August Forel Strasse 7
Zurich 8040
CH
August Forel Strasse 7
Zurich 8040
CH
Listed location countries
Age
Inclusion criteria
- Competent and temporarily incompetent patients age > = 18 years with full thickness skin defects that require skin grafting AND
- Full thickness skin defects configured in such a way that two comparable and measurable areas can be grafted, both of minimally 3x3 cm AND
- <= 50% TBSA (total body surface area) full thickness skin defects at time of intervention AND
- Informed consent by the patient and/or legal representatives.
Exclusion criteria
When any of the following criteria are met, the potential subject will be excluded from participation in this study:
- 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
Design
Recruitment
Medical products/devices used
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In other registers
| Register | ID |
|---|---|
| CCMO | NL50542.094.14 |