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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

Tracking Information
First Submitted Date April 6, 2015
First Posted Date April 17, 2015
Last Update Posted Date April 17, 2015
Study Start Date January 2012
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 14, 2015)
graft survival [ Time Frame: postoperatively after 6 weeks ]
composite graft survival rate
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: April 14, 2015)
  • Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire [ Time Frame: postoperatively 24 weeks ]
    hand function evaluation
  • subjective self-evaluation questionnaire [ Time Frame: postoperatively 24 weeks ]
    subjective self-evaluation of finger looking
  • length of finger shortening [ Time Frame: postoperatively 24 weeks ]
    finger length
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluation of Result and Influence Factors on Composite Graft in Fingertip Amputation
Official Title Evaluation of Result and Influence Factors on Composite Graft in Fingertip Amputation
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.

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

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population A retrospective chart review study. Patients were collected since 1990,
Condition
  • Pinprick Sensation Diminished
  • Amputation, Traumatic
  • Pain
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: April 14, 2015)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2017
Estimated Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • patients refused to participate the study
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT02419885
Other Study ID Numbers KMUH-IRB
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Kaohsiung Medical University Chung-Ho Memorial Hospital
Study Sponsor Kaohsiung Medical University Chung-Ho Memorial Hospital
Collaborators Not Provided
Investigators
Study Chair: huang shu-hung, MD Division of Plastic Surgery, Department of Surgery, Kaohsiung Medical University Hospital
PRS Account Kaohsiung Medical University Chung-Ho Memorial Hospital
Verification Date December 1990