Aim of the study is to investigate if application of a dermal substitute in combination with topical negative pressure can improve the quality of the scar in burn wounds.
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary end point: skin elasticity parameters (representing scar quality) after
3 months
Secondary outcome
Secondary end points: take of graft after 5-7 days, scar assessment scale and
scar colour/ pigmentation (Dermaspectrometer) after 3 months
Background summary
Background
The standard therapy for full thickness wounds is transplantation with a split
thickness skin graft. However, scars usually develop as a result of this
therapy.
Previous research has demonstrated an improvement of scar quality if a dermal
substitute was applied in combination with a split skin graft in reconstructive
wounds, but not so much in burn wounds. One of the problems in burn wounds was
the retarded outgrowth of the skin graft when a dermal substitute was applied
in a one step procedure with the graft. Since then, application of topical
negative pressure has demonstrated that the take and outgrowth of a skin graft
can be improved by this technique. It now seems feasible to combine these two
technologies in order to try and improve the quality of healing of burn wounds
in the acute phase of healing.
Study objective
Aim of the study is to investigate if application of a dermal substitute in
combination with topical negative pressure can improve the quality of the scar
in burn wounds.
Study design
This study is designed as a four-armed prospective comparative study, to be
conducted in the three dutch burn centers, comparing split skin graft with and
without topical negative pressure (TNP) and the dermal substitute Matriderm and
split skin graft with and without TNP in adult patients with acute full
thickness wounds.
Intervention
Group 1: the selected wound will be treated with dermal substitute Matriderm,
split skin graft and VAC therapy
Group 2: the selected wound will be treated with dermal substitute Matriderm,
and split skin graft
Group 3: the selected wound will be treated with a split skin graft and VAC
therapy
Group 4: the selected wound will be treated with a split skin graft.
Study burden and risks
The burden for the patients participating in this study is minimal: the
experimental components of the treatment are added to the usual treatment for
deep wounds that these patients will receive anyhow. Extra burden is
represented by the fact that patients in two out of four groups will receive
Vac therapy. This therapy may limit their freedom of motion during 3 to 5 days
to some extent. Patients entering this study will be evaluated somewhat more
extensively during outpatient follow up visits, at 3 months post-operatively.
This will take approximately 30 to 60 min of their time in total.
Risks associated with the study are a possibly retarded outgrowth of the split
skin, especially in group 2. The chances that the skin graft is lost are judged
to be minimal, based on a previous study (Van Zuijlen et al, Plast. Rec. Surg.
2000; 106, 615-623).
Vondellaan 13
1942 LE Beverwijk
NL
Vondellaan 13
1942 LE Beverwijk
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria:-patients => 18 yrs with acute burns/trauma wounds that require skin grafting
-Minimal study wound surface 10 cm2
-Maximal study wound surface 300 cm2
-maximal TBSA 15% full thickness wounds
-Informed consent
Exclusion criteria
Exclusion criteria:
-Patients with wounds without adequate possibility to apply VAC
-Immunocompromised patients
-Infected wounds
-Pregnant patients
-Patients who 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 (e.g. borderline or depression).
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 | NL18500.094.07 |