Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000816055
Ethics application status
Approved
Date submitted
27/09/2010
Date registered
30/09/2010
Date last updated
30/09/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of Postburn Hand Function after Early Excision and Skin Grafting versus Delayed Skin Grafting; A Randomized Clinical Trial
Scientific title
Evaluation of Postburn Hand Function after Early Excision and Skin Grafting versus Delayed Skin Grafting; A Randomized Clinical Trial
Secondary ID [1] 252766 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
In this study, early excision and skin grafting was compared with delayed skin grafting in deep hand burns 258267 0
Condition category
Condition code
Surgery 258459 258459 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1-In the early excision and grafting group, decision for operation was generally made within 72-hours of admission. In operating room, under general anaesthesia, tourniquets were applied for all patients to control bleeding. The depth at which punctuate bleeding occurred after tangential (layered) excision was used as a final criterion of burn depth. If burn injury remained superficial to the extensor paratenon, the burn was judged to be confined to the cutaneous tissue and the patient was included in the study. If the burn was extending to the extensor tendons, the patient was excluded from the study. Then, after irrigation and careful homeostasis, the tourniquet was inflated again and meshed split-thickness skin was transported to the wound and fixed; after dressing, the tourniquet was deflated. Following skin grafting, all hands were splinted in the anti-deformity position.

2-In delayed excision group, dressing was carried out until spontaneous separation of eschar. All hands were subjected to vigorous irrigation by saline and application of antimicrobial ointments in the form of betadine or nitrofurazone. Nutrition was emphasised, intravenous antibiotics for hospitalized cases were started according to the smear and culture result, which was taken if any sign of infection (cellulites, abnormal discharge, fever, severe pain or poor progression) occurred. Skin grafting was applied when healthy granulation tissue existed. Spontaneous separation of burn eschar and formation of healthy granulation tissue occurred in a range of 13 to 23 days post-burn with an average of 16 days.
In the operating room under general anaesthesia and sterile condition, excess granulation tissue was removed to reach a suitable bed for graft, the meshed split-thickness skin from the healthy skin of thigh or trunk was transferred to the wound bed and fixed with non-absorbable monofilament suture material. Following skin grafting, all hands were splinted in the antideformity position. Commonly, the dressing was removed on the 5th postoperative day and if there was any sign of graft infection (fever, malodorous or draining wound), the dressing was changed sooner.

3-intensive physiotherapy( for all partcipants)
Splinting and Immediate Physiotherapy: All burned hands included in the study were splinted at the time of admission in a dorsal static hand splint. The wrist joint was splinted at 300 hyperextension, the metacarpophalangeal (MCP) joints in 900 flexion, the interphalangeal (IP) joints in extension, and the thumb in abduction. The webs of fingers were kept in abduction. The hands were elevated above the level of the heart to minimize post-burn edema. Physiotherapy was consisted of, active assisted and active range of motion exercises. The frequency of exercises was 2-4 times daily with maximal repetition of 8-10 times for each exercises as reported in our previous work. Physiotherapy was also restarted one week after skin grafting in both groups.
Intervention code [1] 257281 0
Treatment: Surgery
Intervention code [2] 257282 0
Treatment: Other
Intervention code [3] 257292 0
Rehabilitation
Comparator / control treatment
control group will be underwent delayed graft excision
Control group
Active

Outcomes
Primary outcome [1] 259294 0
The total active motion of digits was measured through using standard geniometer.

Grip strength was assessed by the portable hand Jamar dynamometer
Timepoint [1] 259294 0
two weeks and two months post grafting
Secondary outcome [1] 265721 0
Hand function was measured by the Jebsen-Taylor Hand Function Test (JTHFT)
Timepoint [1] 265721 0
three months post grafting

Eligibility
Key inclusion criteria
1-Deep second and third degree dorsal hand burn
2-An average total body surface area (TBSA) less than 30% were included.
3-admission to the emergency sector of the burn unit within 24-hours of the injury.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1- Electrical burn,
2-Fourth-degree burn,
3-Burn as a component of multiple trauma (patients with fractures or central and/ or peripheral nervous system trauma),
4-Elderly patients with co-morbid disease such as chronic cardiovascular disease, diabetes mellitus, hypertension
5- Inhalation injury (Inhalation injury was identified by the presence of orofacial burns with the history of a closed-space injury, bronchoscopic evidence of soot and erythema, or blisters in the trachea or bronchus),
6- Patients who eeded intensive care
7- Delayed resuscitation more than 24 hours after injury.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/05/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 2938 0
Egypt
State/province [1] 2938 0

Funding & Sponsors
Funding source category [1] 257716 0
Self funded/Unfunded
Name [1] 257716 0
Mohammed Taher Ahmed Omar
Country [1] 257716 0
Egypt
Primary sponsor type
Individual
Name
Mohammed Taher Ahmed Omar
Address
Faculty of Physical Therapy, cairo university, Egypt
17, ahmed alzayeat street , cairo
Country
Egypt
Secondary sponsor category [1] 256934 0
None
Name [1] 256934 0
Address [1] 256934 0
Country [1] 256934 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259764 0
faculty councel for post graduated study and resercher
Ethics committee address [1] 259764 0
Ethics committee country [1] 259764 0
Egypt
Date submitted for ethics approval [1] 259764 0
Approval date [1] 259764 0
20/05/2002
Ethics approval number [1] 259764 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31702 0
Address 31702 0
Country 31702 0
Phone 31702 0
Fax 31702 0
Email 31702 0
Contact person for public queries
Name 14949 0
Mohammed Taher Ahmed Omar
Address 14949 0
Collage of Applied Medical Science, King saud univerity
riyadh
P.O Box 10129Riyadh, 1334
Country 14949 0
Saudi Arabia
Phone 14949 0
00966542115404
Fax 14949 0
009664693502
Email 14949 0
[email protected]
Contact person for scientific queries
Name 5877 0
Mohammed Taher Ahmed Omar
Address 5877 0
Collage of Applied Medical Science, King saud univerity
riyadh
P.O Box 10129Riyadh, 1334
Country 5877 0
Saudi Arabia
Phone 5877 0
00966542115404
Fax 5877 0
009664693502
Email 5877 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.