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Evaluation of Result and Influence Factors on Composite Graft in Fingertip Amputation

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ClinicalTrials.gov Identifier: NCT02419885
Recruitment Status : Unknown
Verified December 1990 by Kaohsiung Medical University Chung-Ho Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : April 17, 2015
Last Update Posted : April 17, 2015
Sponsor:
Information provided by (Responsible Party):
Kaohsiung Medical University Chung-Ho Memorial Hospital

Brief Summary:

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.


Condition or disease
Pinprick Sensation Diminished Amputation, Traumatic Pain

Detailed Description:

Fingertip amputations underwent

  1. modified composite grafting with pulp Adipo-fascia advance flap
  2. composite graft
  3. 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


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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Evaluation of Result and Influence Factors on Composite Graft in Fingertip Amputation
Study Start Date : January 2012
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2017



Primary Outcome Measures :
  1. graft survival [ Time Frame: postoperatively after 6 weeks ]
    composite graft survival rate


Secondary Outcome Measures :
  1. Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire [ Time Frame: postoperatively 24 weeks ]
    hand function evaluation

  2. subjective self-evaluation questionnaire [ Time Frame: postoperatively 24 weeks ]
    subjective self-evaluation of finger looking

  3. length of finger shortening [ Time Frame: postoperatively 24 weeks ]
    finger length



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
A retrospective chart review study. Patients were collected since 1990,
Criteria

Inclusion Criteria:

  • February 1990 and June 2015, patients received composite graft in fingertip amputation

Exclusion Criteria:

  • patients refused to participate the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02419885


Contacts
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Contact: huang shu-hung, MD 886-7-3121101 ext 7676 huangsh63@gmail.com

Locations
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Taiwan
Kaohsiung Medical University Hospital Recruiting
Kaohsiung City, Taiwan, 80708
Contact: huang shu-hung, MD    886-7-3121101 ext 7676    huangsh63@gmail.com   
Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
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Study Chair: huang shu-hung, MD Division of Plastic Surgery, Department of Surgery, Kaohsiung Medical University Hospital

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Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT02419885     History of Changes
Other Study ID Numbers: KMUH-IRB
First Posted: April 17, 2015    Key Record Dates
Last Update Posted: April 17, 2015
Last Verified: December 1990
Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
finger amputation
composite graft
adipo-fascia flap
Additional relevant MeSH terms:
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Somatosensory Disorders
Amputation, Traumatic
Wounds and Injuries
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms