to determine the efficiency and feasibility of an autologous tissue engineered skin substitute in healing chronic ulcers (decubitus-, diabetes foot- and venous- ulcers) compared to usual wound care therapies (e.g.: off-loading, wound cleansing,…
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
% decrease of ulcer
Secondary outcome
pain, quality of life, satisfaction patient and caregivers
Background summary
Chronic ulcers are very prevalent in vulnerable aged patients in long term care
settings. These ulcers are often very persistent, have a negative impact on
quality of life and are a burden to both patient and care giver.
Study objective
to determine the efficiency and feasibility of an autologous tissue engineered
skin substitute in healing chronic ulcers (decubitus-, diabetes foot- and
venous- ulcers) compared to usual wound care therapies (e.g.: off-loading,
wound cleansing, compression). The study population is elderly patients
residing in long term care facilities.
Study design
Patients with hard to heal ulcers persisting for more than 4 weeks, size 1 *
100 cm2 and showing no tendency to heal will be included. Ulcers are decubitus
ulcers (stage II-III), diabetic foot ulcers (grade 1-3), and venous ulcers. The
number of patients to be included is 20. These patients will receive skin
substitute after prior wound bed preparation with vacuum assisted closure
therapy.
Intervention
application of an autologous tissue engineered skin substitute
Study burden and risks
Tiscover is an autologous product, it is cultured in a sterile environment and
there is an extended quality control program, which makes side-effects and
risks not to be expected.
Observation in earlier and ongoing treatments acknowledges this.
van der Boechorststraat 7
1081 BT Amsterdam
Nederland
van der Boechorststraat 7
1081 BT Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
· Venous ulcer, arterio(lo)sclerotic ulcer , decubitus ulcer or diabetic ulcer .
· chronic (>1 month no tendency to heal),
· Ulcer 1-100 cm²
· consent (competent)
· Ulcus depth < 1.0 cm
Exclusion criteria
- serious comorbidity (lief expectancy < 6 months)
- use of high dose corticosteroids or cytostatics
- allergy for penicillin
- serious wound infection at t=0
- refusal of necessary clinical treatments
- incompetent for decision making
Design
Recruitment
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 |
|---|---|
| CCMO | NL16543.029.07 |