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Functional outcome of the burned hand after skin grafting.


- candidate number6490
- NTR NumberNTR2017
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-sep-2009
- Secondary IDsNL28408.101.09 CCMO
- Public TitleFunctional outcome of the burned hand after skin grafting.
- Scientific TitleFunctional outcome after skin grafting of the burned dorsal hand in fist position with wrist in 30 flexion: evaluation of a new treatment protocol.
- ACRONYM
- hypothesisThe 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.
Hand burns which are grafted in a fist position, with all fingers flexed in a grip position and a flexed wrist have an improved fucntional outcome .
- Healt Condition(s) or Problem(s) studiedBurns, Hands, Skin graft
- Inclusion criteria1. Patients with burns of the dorsal hand needing skin grafting;
2. The burns should involve at least one of the following joints: Wrist and/or one metacarpophalangeal joint;
3. Informed consent.
- Exclusion criteria1. Age <18 years;
2. Severe cognitive dysfunction;
3. Poor Dutch proficiency;
4. Co morbidity that can influence wound healing (e.g. diabetes);
5. Pre-injury hand problems;
6. Burns of the palmar hand;
7. Burns involving tendons, muscles and ligaments. Deeper structures should be at length, without arthrogene constraints.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 9-jan-2009
- planned closingdate11-jan-2011
- Target number of participants12
- InterventionsIn 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.
- Primary outcomeThe 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 outcomeFeasibility 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.
- TimepointsOutcome assessors will evaluate functional outcome 7 and 14 days post ok and at 1, 5 and 12 months post ok.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. Margriet E. Baar, van
- CONTACT for SCIENTIFIC QUERIESDr. Margriet E. Baar, van
- Sponsor/Initiator Burn Centre, Maasstad Ziekenhuis Rotterdam
- Funding
(Source(s) of Monetary or Material Support)
Stichting Theia, Noordwijk
- PublicationsN/A
- Brief summaryRationale:
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.

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. Study population: Patients with burned dorsal hand requiring skin grafting of the dorsal hand and finger(s). A total of 12 hands will be included.

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. In the comparator group, hand will be grafted in the standard neutral position of wrist and fingers (usual care). In both groups, hands will be fixed 5 days post ok in their position.

Main study parameters/endpoints:
The main study parameter is the difference in time to complete active full fist position between the index and comparator group. Secondary outcome assessment include active and passive joint range of motion, observed and self-reported hand function, muscle strength and oedema. Outcome assessors will evaluate functional outcome 7 and 14 days post ok and at 1, 5 and 12 months post ok. Feasibility will be assessed by evaluation of patient inclusion and drop-out and the burden for patients and staff.
- Main changes (audit trail)
- RECORD18-sep-2009 - 29-okt-2009


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