This trial will compare the effectiveness and possible adverse effects of five common wound dressing materials to treat donor sites of split skin grafts.
ID
Source
Brief title
Condition
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary objective is to promote wound healing.
Secondary outcome
Secondary objectives are pain, comfort, infection rate, and costs.
Background summary
To date there is a large variability in wound dressings regarding the local
treatment of donor site wounds after split skin grafting. This is detrimental
to the uniformity and quality of care for such patients.
Study objective
This trial will compare the effectiveness and possible adverse effects of five
common wound dressing materials to treat donor sites of split skin grafts.
Study design
Multicentre randomised clinical trial with five study arms.
Intervention
Five different wound dressing materials will be compared, namely an alginate, a
film, a hydrocolloid, a paraffin gauze, and a silicone dressing.
Study burden and risks
The dressing materials used in this trial are already commercially available
and therefore do not pose an extra risk. Patioents will be aked to score their
pain, itching and comfort with respect to the dressing material used.
Patients may benefit from participating because they may receive a dressing
material that has advantages, for example in terms of a quicker wound healing
or more pain relief.
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Adults
Condition requiring split skin grafting
Donor site of at least 10 cm2
Written informed consent.
Exclusion criteria
Patients physically or mentally not able to give informed consent
Patients with an impaired wound healing, e.g. undergoing chemotherapy.
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 |
|---|---|
| CCMO | NL28456.018.09 |