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…
ID
Bron
Aandoening
burns
hands
skin grafting
brandwonden
handen
huidtransplantatie
Ondersteuning
Maasstad Ziekenhuis
Postbus 9100
3007 AC Rotterdam, tel 010-2913428
Email:sizoos@maasstadziekenhuis.nl
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
Rationale:
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.
Doel van het onderzoek
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.
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 .
Onderzoeksopzet
Outcome assessors will evaluate functional outcome 7 and 14 days post ok and at 1, 5 and 12 months post ok.
Onderzoeksproduct en/of interventie
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.
Publiek
Maasstad Ziekenhuis, locatie Zuider
Groene Hilledijk 315
Margriet E. Baar, van
Brandwondencentrum Rotterdam,
Maasstad Ziekenhuis, locatie Zuider
Groene Hilledijk 315
Rotterdam 3075
The Netherlands
+31 (0)10 - 2913428
baarm@maasstadziekenhuis.nl
Wetenschappelijk
Maasstad Ziekenhuis, locatie Zuider
Groene Hilledijk 315
Margriet E. Baar, van
Brandwondencentrum Rotterdam,
Maasstad Ziekenhuis, locatie Zuider
Groene Hilledijk 315
Rotterdam 3075
The Netherlands
+31 (0)10 - 2913428
baarm@maasstadziekenhuis.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL1901 |
NTR-old | NTR2017 |
CCMO | NL28408.101.09 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |
OMON | NL-OMON33260 |