- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01767727
Repair of Multiple Finger Defects Using the Dorsal Homodigital Island Flaps
October 25, 2018 updated by: The Second Hospital of Tangshan
Multiple finger defects are common in hand trauma and result in functional disability.
These injuries are often complex and severe, and thus reconstructive alternatives are limited.
In this study, we use the dorsal homodigital island flaps, based on the dorsal branch of the digital artery, for reconstruction of multiple finger defects.
At the final follow-up, we would evaluate the efficacy of this technique.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
At final follow-up, sensation of the flap and the donor site would be assessed using static two-point discrimination and Semmes-Weinstein monofilament testing.
The range of motion of the proximal interphalangeal joint and the distal interphalangeal joint of the injured finger is measured by a goniometer.
The cold intolerance of the injured finger is measured using the self-administered Cold Intolerance Severity Score questionnaire that is rated into mild, moderate, severe, and extreme.
The pain of the injured finger and the donor site is given subjectively by the patient using the visual analogue scale, which ranges from 0 to 10 cm and groupes into mild (0-3 cm), moderate (4-6 cm) and severe (7-10 cm).
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hebei
-
Tangshan, Hebei, China, 063000
- The Second Hospital of Tangshan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 60 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- a patient who had separate soft tissue defects in different fingers in same hand;
- the defect ≥ 1.5 cm and ≤ 3.5 cm in length;
- local tissue near the defect is uninjured; and
- a patient between 15 and 60 years of age.
Exclusion Criteria:
- concomitant injuries to local tissue around the defect that precluded its use as donor site;
- a defect < 1.5 cm and ≥ 3.5 cm in length;
- a finger degloving injury;
- the defect of the thumb.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Surgical flap
Surgical flap is based on the dorsal branch of the digital artery, and is used for soft tissue coverageof multiple finger defects.
|
The dorsal homodigital island flaps are used for soft tissue coverage of multiple finger defects
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
static two-point discrimination
Time Frame: postoperative 18-24 months
|
The test points are at the center of the flap.Each area is tested 3 times with a Discriminator.
We stopp at 4 mm as a limit of two-point discrimination and consider this normal.
|
postoperative 18-24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cold intolerance of the injured finger
Time Frame: Postoperative 18-24 months
|
The cold intolerance of the injured finger was measured using the self-administered Cold Intolerance Severity Score questionnaire that was rated into mild, moderate, severe, and extreme.
|
Postoperative 18-24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hu HT, Chen WH, Liu WC, Hang QW. [Fingertip reconstruction using a volar flap based on the transverse palmar branch of the digital artery]. Zhonghua Zheng Xing Wai Ke Za Zhi. 2005 Sep;21(5):353-5. Chinese.
- Al-Qattan MM. Technical modifications and extended applications of the distally based adipofascial flap for dorsal digital defects. Ann Plast Surg. 2004 Feb;52(2):168-73. doi: 10.1097/01.sap.0000101954.16674.99.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
January 10, 2013
First Submitted That Met QC Criteria
January 11, 2013
First Posted (Estimate)
January 14, 2013
Study Record Updates
Last Update Posted (Actual)
October 29, 2018
Last Update Submitted That Met QC Criteria
October 25, 2018
Last Verified
October 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HB-TS-0130067
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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