1. To assess the feasibility of a new treatment protocol of skin grafting of the burned dorsal hand in fist position with wrist in 30° flexion per and post ok.2. To explore the effects of skin grafting on the burned dorsal hand in fist position with…
ID
Source
Brief title
Condition
- Other condition
- Injuries NEC
Synonym
Health condition
brandwondletsel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the difference in time to complete active full fist
position after operation between the index and comparator group, in days.
Secondary outcome
Feasibility will be assessed by evaluation of patient inclusion and drop-out
and the burden for patients and staff. In addition, pain scores will be
assessed.
Secondary outcome assessment include active and passive joint range of motion
of wrist and fingers, self-reported hand function with the Michigan Hand
Outcome Questionnaire, observed hand function with the Jebsen hand Taylor Test,
muscle strength, oedema and sensibility of the hand. Outcome assessors will
evaluate functional outcome 7 and 14 days post ok and at 1, 5 and 12 months
post ok.
Background summary
The hand is one of the most frequent burned body parts. In severely burned
hands, surgical wound care is often necessary. A split skin graft is used to
cover the wound. Contraction of the skin graft often results in a shortened
skin and in the impossibility to make a fist. Burm et al explored the effects
of a technique in which hands are grafted in a fist position, with all fingers
flexed in a grip position and a flexed wrist. They observed good functional and
cosmetic results. However, no quantitative data were reported.
Study objective
1. To assess the feasibility of a new treatment protocol of skin grafting of
the burned dorsal hand in fist position with wrist in 30° flexion per and post
ok.
2. To explore the effects of skin grafting on the burned dorsal hand in fist
position with wrist in 30° flexion, on range of motion, hand function, muscle
strength and oedema.
Study design
A randomised controlled intervention study.
Intervention
In the index group, the hand will be grafted in a fist position, with all
fingers in a fist position and the wrist in 30° flexion. Hands will be fixed 5
days post ok in this position.
In the comparator group, hand will be grafted in the standard neutral position
of wrist and fingers (usual care). Hands will be fixed 5 days post ok in this
position.
Study burden and risks
The burden for the patients is limited. The experimental fist position in the
index group is added to the usual treatment for deep wounds that these patients
will receive anyhow. Patients entering this study will be evaluated in our burn
unit pre,per and post ok, at day 7 and 14. Patients are evaluated in the
clinical period and are evaluated extensively during the three outpatient
follow-up visits, at 1, 5 and 12 months post-operatively. These visits consist
of physical examination of the hands and assessment of observed and
self-reported functional outcome. This approximately 75 minutes per visit.
Groene Hilledijk 315
3075 EA Rotterdam
NL
Groene Hilledijk 315
3075 EA Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Patients with burns of the dorsal hand needing skin grafting.
The burns should involve at least one of the following joints; wrist and/or one metacarpophalangeal joint.
Informed consent
Exclusion criteria
-Age <18 years
-Severe cognitive dysfunction
-Poor Dutch proficiency
-Co morbidity that can influence wound healing (e.g. diabetes)
-Pre-injury hand problems
-Burns of the palmar hand
-Burns involving tendons, muscles and ligaments. Deeper structures should be at length, without arthrogene constraints.
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL28408.101.09 |
| OMON | NL-OMON23634 |