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

Primary Purpose

Finger Injuries, Soft Tissue Injuries

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dorsal digito-metacarpal flap
Sponsored by
The Second Hospital of Tangshan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Finger Injuries focused on measuring defect,, dorsal branch of the digital artery,, dorsal digital flap,, dorsal metacarpal artery flap.

Eligibility Criteria

15 Years - 55 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Second Hospital of Tangshan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Surgical flap

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
August 19, 2013
Last Updated
October 25, 2018
Sponsor
The Second Hospital of Tangshan
Collaborators
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01927003
Brief Title
Direct and Reversed Dorsal Digito-metacarpal Flaps: A Review of 24 Cases
Official Title
Direct and Reversed Dorsal Digito-metacarpal Flaps: A Review of 24 Cases
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Hospital of Tangshan
Collaborators
Chinese PLA General Hospital

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Finger Injuries, Soft Tissue Injuries
Keywords
defect,, dorsal branch of the digital artery,, dorsal digital flap,, dorsal metacarpal artery flap.

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Surgical flap
Arm Type
Experimental
Arm Description
Dorsal digito-metacarpal flap is based on the dorsal digital artery and dorsal metacarpal artery.
Intervention Type
Procedure
Intervention Name(s)
Dorsal digito-metacarpal flap
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Static 2-point discrimination test
Description
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.
Time Frame
18 to 24months
Secondary Outcome Measure Information:
Title
Patient satisfaction
Description
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.
Time Frame
18 to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
The Second Hospital of Tangshan
City
Tangshan
State/Province
Hebei
ZIP/Postal Code
063000
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
11324891
Citation
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.
Results Reference
result
PubMed Identifier
24315482
Citation
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.
Results Reference
derived

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

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