The Dorsal Homodigital Island Flap Based on the Dorsal Branch of the Digital Artery: A Review of 171 Cases

Soft Tissue Defect Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01871103
• Other study ID #: HBTS1306017
• Status: Completed
• Phase: N/A
• First received: June 3, 2013
• Last updated: June 5, 2013
• Start date: January 2006
• Est. completion date: March 2013

Study information

• Verified date: January 2007
• Source: The Second Hospital of Tangshan
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Soft tissue reconstruction in the finger continues to evolve. The dorsum of the finger is a reliable flap donor site in reconstructive hand surgery because of its similar quality to the original. The dorsal homodigital island flap can be used as a reliable alternative for reconstructing small to moderate defects of the fingers. In this retrospective study, the investigators would evaluate the efficacy of the technique for tissue reconstruction in different regions of the finger, with an emphasis on sensibility, pain and donor site morbidity.

Description:

At final follow-up, sensory restoration of the flap is measured using the static 2-point discrimination test and Semmes-Weinstein monofilament test. We evaluate pain sensations of the reconstructed fingers and donor sites with a visual analog scale. The system consist of a 10 cm line that is grouped into mild (0-3 cm), moderate (4-6 cm) and severe (7-10 cm). Active motion of the joints is measured using a goniometer. The motion arcs of the reconstructed fingers are compared with the opposite side.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: March 2013
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• the soft tissue defect in one finger or in multiple fingers

• a defect > 1.5 cm and < 3 cm in length

• necessity to preserve finger length

• a patient between 15 and 60 years of age

Exclusion Criteria:

• injuries to the dorsum of the finger or to the course of the vascular pedicle that precluded its use as the donor

• a defect=1.5 cm or =3 cm in length

• a soft tissue defect of the thumb

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Digital Defects
• Sensory Reconstruction of Digits
• Soft Tissue Defect

Intervention

Procedure:
• The dorsal homodigital island flap
The dorsal homodigital island flap is used for tissue reconstruction in different regions of the finger.

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 (1)

Chen C, Tang P, Zhang X. Sensory reconstruction of a finger pulp defect using a dorsal homodigital island flap. Plast Reconstr Surg. 2012 Nov;130(5):1077-86. doi: 10.1097/PRS.0b013e318267ef99. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Static 2-point discrimination test	The test point is at the center of the flap. Each area was tested 3 times with a Discriminator (Ali Med, Dedham, MA). We stop at 4mm as a limit of 2PD and considered this normal.	18 months to 24 months	No
Secondary	Cold intolerance	We access the cold intolerance of the injured and donor fingers using the self-administered Cold Intolerance Severity Score questionnaire10 that is rated into mild, moderate, severe, and extreme (0-25, 26-50, 51-75 and 76-100).	18 months to 24 months	No