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Trial registered on ANZCTR


Registration number
ACTRN12611000904976
Ethics application status
Approved
Date submitted
16/08/2011
Date registered
24/08/2011
Date last updated
31/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of the Sensory Outcomes between the iRASP and the Free Thenar Flap in patients with a soft tissue defect on a thumb or finger
Scientific title
Comparison of the Sensory Outcomes between the iRASP and the Free Thenar Flap in patients with a volar soft tissue defect on a thumb or finger
Secondary ID [1] 262841 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
coverage of soft tissue defect on a volar side of finger with sensate flap of the iRASP flap 270510 0
Condition category
Condition code
Surgery 270674 270674 0 0
Surgical techniques
Skin 270774 270774 0 0
Dermatological conditions
Injuries and Accidents 270775 270775 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The iRASP flap is a new modification of the free thenar flap for constant innervation with the PCMN(Palmar Cutaneous branch of the Median Nerve). If there is a soft tissue defect on volar aspect in thumb or fingers, especially a pinching site, the iRASP flap would be applied. The procedure of the iRASP flap takes about 3 hours. The sensory outcomes will be checked by SWM(Semmes-Weinstein Monofilaments), S2PD(Static Two-Point Discrimination) and M2PD(Moving Two-Point Discrimination) tests. The results of sensory outcomes in the iRASp group will be compared with the results in the free thenar flap group. The cases of the free thenar flap which were able to be followed up was selected among the cases that had been performed before the authors designed the iRASP flap. The cases of the free thenar flap would be reviewed by medical record and evaluated by the above methods of sensory evaluation.
Intervention code [1] 269149 0
Treatment: Surgery
Intervention code [2] 269150 0
Rehabilitation
Comparator / control treatment
The results of sensory evaluation in the iRASP group will be compared with the results of the results in the free thenar flap group and results of the uninjured contralateral thumb or finger in a patient. The cases of the free thenar flap which were able to be followed up was selected among the cases that had been performed before the authors designed the iRASP flap. The results of sensory restoration in the free thenar flap group was evaluated during two months (March, 2010 to April, 2010). Statistical analysis with median test would be applied for comparison.
Control group
Historical

Outcomes
Primary outcome [1] 269391 0
SWM(Semmes-Weinstein Monofilaments) Test that can measures the integrity of afferent fibers.
Timepoint [1] 269391 0
This test will be performed at every month after coverage with the iRASP flap for a total of 12 months.
In the free thenar flap group, this test was conducted when the patient visited.
Primary outcome [2] 269392 0
S2PD(Static Two-Point Discrimination) test is a discrimination test. The ability can distinguish the two-point applied on skin as two point. If sensory recovery is not enough, a patient can not distinguish two-point as a one point. It can evaluates the slowly-adapting fiber-receptor system (constant touch).
Timepoint [2] 269392 0
This test will be performed at every month after coverage with the iRASP flap for a total of 12 months.
In the free thenar flap group, this test was conducted when the patient visited.
Primary outcome [3] 269393 0
M2PD(Moving Two-Point Discrimination) test can evaluates the innervation density of the quickly-adapting fiber-receptor system which mediates the perception of stimuli moving across the hand.
Timepoint [3] 269393 0
This test will be performed at every month after coverage with the iRASP flap for a total of 12 months.
In the free thenar flap group, this test was conducted when the patient visited.
Secondary outcome [1] 287537 0
complications(tender scar, limitation of thumb motion or neuroma formation)
Tender scar will be assessed by visual analogue scale that a patient express the amount of discomfort. Limitation of thumb motion on a injured hand ( a same side of the donor site of the iRASP or the free thenar flap) will be assessed by measuring the angle of palmar and radial abduction of thumb. The measured angles will be compared with the results of uninjured (contralateral) hand. The formation of neuroma will be tested by the Tinel's sign. The amount of discomfort will be expressed by the visual analogue scale.
Timepoint [1] 287537 0
In both groups of the iRASP and the free thenar flap, these complications will be evaluated. The iRASP flap group will be checked serially every month for up to 6 months postoperatively. The free thenar flap group will be assessed at the time of follow-up.

Eligibility
Key inclusion criteria
In both groups of the iRASP and the free thenar flap, the patients have a volar soft tissue defect on a thumb or finger. A defect is located on pinching area and relatively large not covered easily by small sized flaps like cross finger flap or free partial toe pulp flap.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
A patient having a general disease related with nerve recovery or compressive neuropathy should be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
9/10/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment outside Australia
Country [1] 3777 0
Korea, Republic Of
State/province [1] 3777 0

Funding & Sponsors
Funding source category [1] 269627 0
Self funded/Unfunded
Name [1] 269627 0
Country [1] 269627 0
Primary sponsor type
Individual
Name
JAE-WON YANG
Address
Hand and Microsurgery Center,
Department of Plastic and Reconstructive Surgery,
Kwang-Myung Sung-Ae General Hospital,
389, Chul-San-3-Dong,Gwang-Myeong-Si,
Gyeong-Gi-Do, 423-711
Country
Korea, Republic Of
Secondary sponsor category [1] 266657 0
None
Name [1] 266657 0
Address [1] 266657 0
Country [1] 266657 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269612 0
Gwang-Myeong Sung-Ae IRB(Institutional Review Board)
Ethics committee address [1] 269612 0
389, Chul-San-3-Dong,
Gwang-Myeong-Si,
Gyeong-Gi-Do, 423-711
Ethics committee country [1] 269612 0
Korea, Republic Of
Date submitted for ethics approval [1] 269612 0
Approval date [1] 269612 0
01/09/2009
Ethics approval number [1] 269612 0

Summary
Brief summary
This study is intended to compare sensory restoration between the iRASP (sensate flap) and the free thenar flap (nonsensate flap). Because, it was reported that the free thenar flap has satisfactory result of sensory restoration even though the flap do not incorporate a nerve for innervation. It is worthy whether the sensate iRASP flap sacrificing a nerve is necessary. Our data will be useful for a surgeon deciding between a sensate or non-sensate flap for coverage of a volar soft tissue defect on a thumb or finger.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32994 0
Address 32994 0
Country 32994 0
Phone 32994 0
Fax 32994 0
Email 32994 0
Contact person for public queries
Name 16241 0
JAE-WON YANG
Address 16241 0
Hand and Microsurgery Center,
Department of Plastic and Reconstructive Surgery,
Gwang-Myeong Sung-Ae General Hospital,
389, Chul-San-3-Dong,
Gwang-Myeong-Si,
Gyeong-Gi-Do, 423-711
Country 16241 0
Korea, Republic Of
Phone 16241 0
+82-2-2680-7238
Fax 16241 0
+82-2-2615-7218
Email 16241 0
[email protected]
Contact person for scientific queries
Name 7169 0
JAE-WON YANG
Address 7169 0
Hand and Microsurgery Center,
Department of Plastic and Reconstructive Surgery,
Kwang-Myung Sung-Ae General Hospital,
389, Chul-San-3-Dong,
Gwang-Myeong-Si,
Gyeong-Gi-Do, 423-711
Country 7169 0
Korea, Republic Of
Phone 7169 0
+82-2-2680-7238
Fax 7169 0
+82-2-2615-7218
Email 7169 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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