- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02419885
Evaluation of Result and Influence Factors on Composite Graft in Fingertip Amputation
Fingertips facilitate smooth motor activity, precise sensation, and the delicate movement of the hands and have an aesthetic function. Fingertip injuries are defined as injuries occurring distal to the insertion of the flexor and extensor tendons. These injuries are one of the most common trauma injuries presented in acute care settings, accounting for approximately 4.8 million emergency department visits per year in the United States.(1) Fingertip amputations may not constitute the majority among these fingertip injuries but can have a complex spectrum of injury. In these cases, the reconstruction methodologies focus on preserving the digital length, ensuring adequate soft tissue coverage, preserving the nail structure, achieving a well-contoured and painless fingertip, and restoring durable and sensate skin.
There are so many factor that influence the result of composite graft in distal finger tip amputation. Investigators will collected the data including the size of amputee , shape, level of amputation, mechanism of amputation, if hyperbaric oxygen therapy, operation procedures.
Study Overview
Status
Detailed Description
Fingertip amputations underwent
- modified composite grafting with pulp Adipo-fascia advance flap
- composite graft
- revision amputation was collected in this study
Follow-up was arranged in out-patient department, including:
type of amputation ( Hirase classification, ) 2-point discrimination test, DASH(Disabilities of the Arm, Shoulder, and Hand) outcome measure, graft survival, pain evaluation with visual Analog scale other associated treatment such as hyperbaric oxygen therapy length of finger shortening at 6 month after operation
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Kaohsiung City, Taiwan, 80708
- Recruiting
- Kaohsiung Medical University Hospital
-
Contact:
- huang shu-hung, MD
- Phone Number: 7676 886-7-3121101
- Email: huangsh63@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- February 1990 and June 2015, patients received composite graft in fingertip amputation
Exclusion Criteria:
- patients refused to participate the study
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
graft survival
Time Frame: postoperatively after 6 weeks
|
composite graft survival rate
|
postoperatively after 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire
Time Frame: postoperatively 24 weeks
|
hand function evaluation
|
postoperatively 24 weeks
|
|
subjective self-evaluation questionnaire
Time Frame: postoperatively 24 weeks
|
subjective self-evaluation of finger looking
|
postoperatively 24 weeks
|
|
length of finger shortening
Time Frame: postoperatively 24 weeks
|
finger length
|
postoperatively 24 weeks
|
Collaborators and Investigators
Investigators
- Study Chair: huang shu-hung, MD, Division of Plastic Surgery, Department of Surgery, Kaohsiung Medical University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KMUH-IRB
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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