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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02419885
• Other study ID #: KMUH-IRB
• Status: Recruiting
• Phase: N/A
• First received: April 6, 2015
• Last updated: April 14, 2015
• Start date: January 2012
• Est. completion date: June 2017

Study information

• Verified date: December 1990
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: huang shu-hung, MD
• Phone: 886-7-3121101
• Email: huangsh63[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• patients refused to participate the study

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Amputation, Traumatic
• Pain
• Pinprick Sensation Diminished

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung City

Sponsors (1)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	graft survival	composite graft survival rate	postoperatively after 6 weeks	No
Secondary	Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire	hand function evaluation	postoperatively 24 weeks	No
Secondary	subjective self-evaluation questionnaire	subjective self-evaluation of finger looking	postoperatively 24 weeks	No
Secondary	length of finger shortening	finger length	postoperatively 24 weeks	No