NCT01927003

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2013

Completed
Last Updated

October 29, 2018

Status Verified

April 1, 2010

Enrollment Period

2.4 years

First QC Date

August 19, 2013

Last Update Submit

October 25, 2018

Conditions

Keywords

defect,dorsal branch of the digital artery,dorsal digital flap,dorsal metacarpal artery flap.

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Patient satisfaction

    18 to 24 months

Study Arms (1)

Surgical flap

EXPERIMENTAL

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

Procedure: Dorsal digito-metacarpal flap

Interventions

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.

Surgical flap

Eligibility Criteria

Age15 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Hospital of Tangshan

Tangshan, Hebei, 063000, China

Location

Related Publications (2)

  • 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. doi: 10.1097/00000637-200104000-00017.

  • Chen C, Zhang W, Tang P. Direct and reversed dorsal digito-metacarpal flaps: a review of 24 cases. Injury. 2014 Apr;45(4):805-12. doi: 10.1016/j.injury.2013.11.002. Epub 2013 Nov 13.

MeSH Terms

Conditions

Finger InjuriesSoft Tissue Injuries

Condition Hierarchy (Ancestors)

Hand InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2013

First Posted

August 21, 2013

Study Start

April 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2012

Last Updated

October 29, 2018

Record last verified: 2010-04

Locations