Objective: To demonstrate the efficacy of a novel matrix therapy based technology that creates improved wound healing in a clinical donor site model.
ID
Source
Brief title
Condition
- Procedural related injuries and complications NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
-Clinical improvement of the donor site wound, measured as reduction in wound
size in time.
Secondary outcome
-Complete healing of the wound, measured as the time needed for complete
healing.
-Improvement of the quality of the (former) wound area to be measured as the
amount of vascularisation, skin pigmentation and elasticity.
-Pain reduction.
-Itch reduction.
Background summary
OTR4120 is a heparan sulfate mimetic that optimizes the regeneration of injured
tissues by sequestering growth factors in the extracellular matrix. From
multiple animal studies it is known that OTR4120 application to wounds improves
tissue regeneration both in speed of healing and in improved tissue
architecture.
Split-skin grafts change the matrix- en celular bed of the epidermis.
Destruction of the cells and the matrix release enzymes who destroy the
glycosaminoglycans (GAG) and proteins, present in the extracellular matrix. The
natural repair process of a wounds needs recovery of the matrix and the
formation of novel matrix components. In addition, the replacement of dead
cells by new cells is needed. This takes place from adjecent identical cell
populations that multiply and migrate to the wound area. During wound repair
this process is suboptimal, which hampers the influx of cells.
OTR4120 is a structural and functional analogue of GAG. From multiple animal
studies it is known that OTR4120 application on wounds increases the speed of
healing and tissue architecture of the regenerate. When applied to a wound
area, OTR4120, like a GAG, bind to specific areas on the extracellular matrix
where the GAG*s were degraded. By protecting matrix proteins from degradation,
it stimulates cell attachement, cell migration and cell devision. This way
OTR4120 will act as wound repair enhancer.
Study objective
Objective: To demonstrate the efficacy of a novel matrix therapy based
technology that creates improved wound healing in a clinical donor site model.
Study design
Dubbel blinded, placebo controlled trial for 19 patients having a standardised
split-skin graft donor site wound. This wound will be divided in 3 parts. The
proximal and distal part will be treated, during 2 weeks, with OTR4120 or
placebo. The middle part of the wound will be untreated. In addition, regular
treatment will be given to these patients.
Intervention
Wetted compresses, soaked in OTR4120 or placebo, will be placed on parts of the
wound during 5 minutes.
Study burden and risks
Burden: OTR4120 or placebo, on a wetted gauze, will be placed on the wound
during 5 minutes followed by the standardized regular treatment.
Risks: no risks in the use of the dextranderivative OTR4120, used in a
microgram range per treatment, are known or expected.
Dr Molewaterplein 50
3015 GD Rotterdam
NL
Dr Molewaterplein 50
3015 GD Rotterdam
NL
Listed location countries
Age
Inclusion criteria
1. Informed consent
2. Aged over 18 yrs
3. Patients in need of an autologous skin graft
4. Adequate nutritional state
5. Adequate immuno-competence
6. Women in reproductive age take contraceptive medication
Exclusion criteria
1- Minor patients
2- Pregnant or breastfeeding women
3- Patients unable to sign the informed consent
4- Uninsured patients
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 | EUCTR2009-010478-39-NL |
| CCMO | NL25119.078.09 |