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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01767727
Other study ID # HB-TS-0130067
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2008
Est. completion date October 2012

Study information

Verified date October 2012
Source The Second Hospital of Tangshan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date October 2012
Est. primary completion date August 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 60 Years
Eligibility Inclusion Criteria:

1. a patient who had separate soft tissue defects in different fingers in same hand;

2. the defect = 1.5 cm and = 3.5 cm in length;

3. local tissue near the defect is uninjured; and

4. a patient between 15 and 60 years of age.

Exclusion Criteria:

1. concomitant injuries to local tissue around the defect that precluded its use as donor site;

2. a defect < 1.5 cm and = 3.5 cm in length;

3. a finger degloving injury;

4. the defect of the thumb.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Soft tissue coverage
The dorsal homodigital island flaps are used for soft tissue coverage of multiple finger defects

Locations

Country Name City State
China The Second Hospital of Tangshan Tangshan Hebei

Sponsors (2)

Lead Sponsor Collaborator
The Second Hospital of Tangshan Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary static two-point discrimination 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 Cold intolerance of the injured finger 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
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