To evaluate the safety of an autologous cellular collagen hydrogel-based skin graft (denovoDerm) in patients with skin defects that require definitive therapeutic coverage. DenovoDerm can be transplanted together with an STSG to cover a full…
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
The primary outcome variables for safety are the rate of local infection and
graft take.
The rate of local infection will be evaluated 4-6 days after transplantation of
denovoDerm and at 21 ±1 days after transplantation. This will be evaluated
with clinical andmicrobial characteristics by an experienced (plastic) surgeon
or medical researcher.
Graft take will be evaluated 21 ±1 days after transplantation in a standardized
fashion by an experienced (plastic) surgeon or medical researcher. Graft take
will be depicted as a percentage of transplanted area.
Secondary outcome
The secondary outcome variable is the number of adverse events. This will be
evaluated during clinical admission to the hospital and during outpatient
visits.
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 cosmesis. 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 skin substitute could improve
outcome of scars.
Study objective
To evaluate the safety of an autologous cellular collagen hydrogel-based skin
graft (denovoDerm) in patients with skin defects that require definitive
therapeutic coverage. DenovoDerm can be transplanted together with an STSG to
cover a full thickness skin defect. DenovoDerm can be grafted in a single-step
procedure.
Study design
A multinational phase I clinical trial will be conducted at the VU University
Medical Centre in Amsterdam, the Red Cross Hospital in Beverwijk and the
Kinderspital, a Swiss pediatric burn centre in Zurich, in collaboration with
the respective departments of plastic, reconstructive and hand surgery.
Intervention
The use of a dermal (combined with a STSG) cellular collagen hydrogel-based
skin graft on a full thickness skin defect.
Study burden and risks
The burden for the participating patients is minimal. Extra burden is
represented by the obtaining of the biopsy, which will be used to isolate cells
for culture of the construct, the fact that the evaluation of the wounds will
take more time at follow-up, and by the optional biopsies at 3 months
follow-up. A possible risk will be intolerance or an allergic reaction to one
of the skin-graft components. Other than these, no additional risks when
compared to the standard treatment are envisioned. 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. Taken
together, to the best of our current knowledge, the estimated risk/benefit
ratio is favourable.
August Forel Strasse 7
Zurich 8040
CH
August Forel Strasse 7
Zurich 8040
CH
Listed location countries
Age
Inclusion criteria
- Age > 18 years and < 70 years
- Medical indication for reconstructive surgery in which a full thickness skin defect arises which otherwise would be closed with STSG
- Written informed consent by the patient
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 or positive general microbiological swabs taken from the nose for multi-resistant germs
- Patients tested positive for HBV, HCV, syphilis or HIV
- Patients with known underlying or concomitant medical conditions that may interfere with normal wound healing (e.g. immune deficiency, systemic skin diseases, any kind of congenital defect of metabolism including diabetes)
- Coagulation disorders as defined by INR outside its normal value, PTT >ULN and fibrinogen - Previous enrolment of the patient into the current study
- Participation of the patient in anotherinterventional study within 30 days preceding and during the present study
- Patients expected not to comply with the study protocol
- Suspicion of child abuse (for the study in Switzerland)
- Pregnant or breast feeding patients
- Contamination derived from biopsy which could interfere with patients health. The decision will be taken after discussion with the responsible physicians.
- Due to patient derived variations, isolated cells from biopsy do not proliferate or proliferate insufficiently
- Skin substitute has not been released due to production specific deviations
- Patients allergic to amphotericin B and gentamicin
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2015-002725-19-NL |
| CCMO | NL53075.000.15 |