Repair of Multiple Finger Defects Using the Dorsal Homodigital Island Flaps

This study has been completed.

Sponsor:

Collaborator:

Chinese PLA General Hospital

Information provided by (Responsible Party):

The Second Hospital of Tangshan

ClinicalTrials.gov Identifier:

NCT01767727

First received: January 10, 2013

Last updated: January 11, 2013

Last verified: October 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 10, 2013
Last Updated Date	January 11, 2013
Start Date ^ICMJE	March 2008
Primary Completion Date	August 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 11, 2013)	static two-point discrimination [ Time Frame: postoperative 18-24 months ] [ Designated as safety issue: No ] 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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01767727 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 11, 2013)	Cold intolerance of the injured finger [ Time Frame: Postoperative 18-24 months ] [ Designated as safety issue: No ] 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.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Repair of Multiple Finger Defects Using the Dorsal Homodigital Island Flaps
Official Title ^ICMJE	Not Provided
Brief 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.
Detailed 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).
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Condition ^ICMJE	Multiple Finger Defects; Dorsal Homodigital Island Flap;
Intervention ^ICMJE	Procedure: Soft tissue coverage The dorsal homodigital island flaps are used for reconstruction of multiple finger defects
Study Arm (s)	Surgical flap The dorsal homodigital island flaps is based on the dorsal branch of the digital artery, and is used for reconstruction of multiple finger defects. Intervention: Procedure: Soft tissue coverage
Publications *	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. 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	12
Completion Date	October 2012
Primary Completion Date	August 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: a patient who had separate soft tissue defects in different fingers in same hand; the defect ≥ 1.5 cm and ≤ 3.5 cm in length; local tissue near the defect is uninjured; and a patient between 15 and 60 years of age. Exclusion Criteria: concomitant injuries to local tissue around the defect that precluded its use as donor site; a defect < 1.5 cm and ≥ 3.5 cm in length; a finger degloving injury; the defect of the thumb.
Gender	Both
Ages	15 Years to 60 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	China

Administrative Information
NCT Number ^ICMJE	NCT01767727
Other Study ID Numbers ^ICMJE	HB-TS-0130067
Has Data Monitoring Committee	Yes
Responsible Party	The Second Hospital of Tangshan
Study Sponsor ^ICMJE	The Second Hospital of Tangshan
Collaborators ^ICMJE	Chinese PLA General Hospital
Investigators ^ICMJE	Not Provided
Information Provided By	The Second Hospital of Tangshan
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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