Soft Tissue Injuries Clinical Trial
Official title:
Repair of Multiple Finger Defects Using the Dorsal Homodigital Island Flaps
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 |
Verified date | October 2012 |
Source | The Second Hospital of Tangshan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | The Second Hospital of Tangshan | Tangshan | Hebei |
Lead Sponsor | Collaborator |
---|---|
The Second Hospital of Tangshan | Chinese PLA General Hospital |
China,
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
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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