Direct and Reversed Dorsal Digito-metacarpal Flaps: A Review of 24 Cases

Soft Tissue Injuries Clinical Trial

Official title:

Direct and Reversed Dorsal Digito-metacarpal Flaps: A Review of 24 Cases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01927003
• Other study ID #: HBTS1308112
• Secondary ID: CHS130-00215
• Status: Completed
• Phase: N/A
• Start date: April 2009
• Est. completion date: September 2012

Study information

• Verified date: April 2010
• Source: The Second Hospital of Tangshan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Multiple digital injuries are often complex and severe, and the commonly used local and regional flaps may not be feasible. The authors reconstruct soft tissue defects of the fingers using the dorsal digito-metacarpal flap and evaluate the efficacy of this technique.

Description:

At final follow-up, we measure the sensibility of the flaps using the static 2-point discrimination test. The Static 2-point discrimination test determines the minimal distance at which a subject can sense the presence of two needle. The modified American Society for Surgery of the Hand guidalines are used to stratify discriminator measurements(excellent <6 mm, good 6-10 mm, fair 11-15 mm, poor >15 mm). Each area is tested 3 times with a Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers are considered proof of perception before proceeding to another lower value. We stopp at 4mm as a limit of 2PD and consider this normal. The measurements are performed at a single time point at final follow up.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 55 Years

Eligibility

Inclusion Criteria:

• the injured and adjacent fingers are unable to be used as the donor due to multiple digital injuries

• a soft tissue defect > 1.5 cm in length with exposed bone or tendon

• the reverse DMA flap may not be appropriate for tissue reconstruction due to the concomitant injuries or due to the limitation of the rotation arc

• a patient between 15 and 60 years of age

Exclusion Criteria:

• concomitant injuries involved all the finger that precluded their use as donor sites

• a defect less than 1.5 cm in length

• injuries to the course of the vascular pedicle

Related Conditions & MeSH terms

• Finger Injuries
• Soft Tissue Injuries
• Wounds and Injuries

Intervention

Procedure:
• Dorsal digito-metacarpal flap
The dorsal digito-metacarpal flap is a vascular island flap based on the dorsal digital artery and dorsal metacarpal artery. It has a longer vascular pedicle and provides tissue coverage of similar quality as that of normal glabrous skin but not sacrifice the digital artery.

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)

Yang D, Morris SF. Reversed dorsal digital and metacarpal island flaps supplied by the dorsal cutaneous branches of the palmar digital artery. Ann Plast Surg. 2001 Apr;46(4):444-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Static 2-point discrimination test	The Static 2-point discrimination test determines the minimal distance at which a subject can sense the presence of two needle. The modified American Society for Surgery of the Hand guidalines are used to stratify discriminator measurements(excellent <6 mm, good 6-10 mm, fair 11-15 mm, poor >15 mm). Each area is tested 3 times with a Discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers are considered proof of perception before proceeding to another lower value. We stopped at 4mm as a limit of 2PD and considered this normal. The measurements are performed at a single time point at final follow up.	18 to 24months
Secondary	Patient satisfaction	Patients report their satisfaction with the appearance of the flap and the donor site according to the Michigan Hand Outcomes Questionnaire that is based on a 5-point response scale.	18 to 24 months