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

Sponsor
The Second Hospital of Tangshan (Other)
Overall Status
Completed
CT.gov ID
NCT01927003
Collaborator
Chinese PLA General Hospital (Other)
24
1
1
41
0.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Dorsal digito-metacarpal flap
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Direct and Reversed Dorsal Digito-metacarpal Flaps: A Review of 24 Cases
Study Start Date :
Apr 1, 2009
Actual Primary Completion Date :
Sep 1, 2011
Actual Study Completion Date :
Sep 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Surgical flap

Dorsal digito-metacarpal flap is based on the dorsal digital artery and dorsal metacarpal artery.

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.

Outcome Measures

Primary Outcome Measures

  1. The Static 2-point discrimination test [18 to 24months]

    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.

Secondary Outcome Measures

  1. Patient satisfaction [18 to 24 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Second Hospital of Tangshan Tangshan Hebei China 063000

Sponsors and Collaborators

  • The Second Hospital of Tangshan
  • Chinese PLA General Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Second Hospital of Tangshan
ClinicalTrials.gov Identifier:
NCT01927003
Other Study ID Numbers:
  • HBTS1308112
  • CHS130-00215
First Posted:
Aug 21, 2013
Last Update Posted:
Oct 29, 2018
Last Verified:
Apr 1, 2010

Study Results

No Results Posted as of Oct 29, 2018