To assess and compare long term scar quality of deep dermal burns after debridement with hydrosurgical- and conventional tangential excision.
Source
Brief title
Condition
- Injuries NEC
- Skin and subcutaneous tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
The main study parameter is scar quality assessed as the POSAS (Patient and
Observer Scar Assessment Scale) Observer Score at 12 months post-burn scored by
2 blinded observers independently.
Secondary outcome
In addition we compare dermal preservation after the two different kinds of
surgery and calculate the Minimal Important Change of the POSAS. This is the
minimal difference in scar quality that patients experience as important.
Background summary
Burn eschar is conventionally removed by tangential excision. This procedure is
not only associated with substantial blood loss but also with unnecessary
removal of viable dermis. During the last decade hydrosurgery has become
popular in burn surgery. Hydrosurgery is generally thought to be a more precise
and controlled manner of burn debridement leading to preservation of more
dermal viable tissue and possibly to better scar quality. In patients with an
indication for surgical treatment of their burns admitted in one of the three
Dutch burn centres in the last 6 years, hydrosurgery (Versajet) was used in
43%. Two randomised controlled trials compared conventional and hydrosurgical
excision of burns, however these studies did not address scar quality as
primary outcome. Nevertheless, a non-randomised retrospective study, did
compare scar quality as primary long term outcome, and reported a better scar
quality after hydrosurgical excision in a subgroup (age 5 years and older) of
their study population. To provide stronger evidence to prove that hydrosurgery
results in a superior scar quality, a prospective study is needed.
Study objective
To assess and compare long term scar quality of deep dermal burns after
debridement with hydrosurgical- and conventional tangential excision.
Study design
A multicentre randomized intra-patient controlled trial.
Intervention
Prior to surgery the study wound will be divided into two parts of equal size,
which are randomly allocated to either conventional or hydrosurgical tangential
excision. Two punch biopsies of both intervention areas will be collected
before and after excision to determine dermal preservation.
Study burden and risks
All participants will have to undergo surgery with the associated risks. Both
treatments are applied in the Netherlands and considered as standard treatment.
Therefore, there is no additional risk or discomfort for the patient. Post
operative care will be as usual. Follow-up assessments will be performed in the
oupatient clinic at 3, 6 and 12 months post-burn and all tests are
non-invasive. These study follow-up visits will take place in the outpatient
clinic and the timing is similar to the standard follow up schedule after a
burn injury in Dutch specialised burn care.
Maasstadweg 21
Rotterdam 3079 DZ
NL
Maasstadweg 21
Rotterdam 3079 DZ
NL
Listed location countries
Age
Inclusion criteria
Deep dermal burns of at least 50cm2 who require primary excision and grafting.
Exclusion criteria
- No operation indication
- TBSA < 50cm2
- TBSA > 30%
- Full thickness burns
- Chemical or electrical burns
- Infected wounds
- No informed consent
- Patients that are unlikely to comply with requirement of the study protocol and follow-up
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 | NL58875.101.16 |