NCT03717220

Brief Summary

Reconstruction of soft-tissue defects in multiple digits poses a significant challenge. This article reports simultaneous reconstruction of multiple small-to-moderate soft-tissue defects using regional dorsal digital island flaps and evaluated the efficacy of their application in such complex situation. A retrospective study will be conducted with 26 patients who had multiple-digit soft-tissue defects treated with regional dorsal digital island flaps. At the final follow-up, we will evaluate the efficacy of their application in such complex situation.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable

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

July 15, 2008

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2016

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
Last Updated

October 24, 2018

Status Verified

June 1, 2018

Enrollment Period

7.8 years

First QC Date

October 22, 2018

Last Update Submit

October 22, 2018

Conditions

Finger Injuries

Keywords

soft-tissue defectsdorsal branch of the digital arteryregional flap

Outcome Measures

Primary Outcomes (1)

  • Static 2PD test

    We use a Disk-Criminator to test two nearby points when touching the flap

    18 months to 24 months

Study Arms (1)

flaps

OTHER

flap transferring is used for reconstruction of multiple small-to-moderate soft-tissue defects

Procedure: flap transferring

Interventions

flap transferringPROCEDURE

we use regional dorsal digital flaps for simultaneous reconstruction of multiple-digit soft-tissue defects

flaps

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • the separate soft tissue defects with exposed bone or tendon in different digits
  • the soft-tissue defect≥1.5 cm and ≤3.5 cm in length
  • necessity to preserve digit length
  • local tissue near the defect can be used as the donor
  • a patient between 15 and 60 years of age

You may not qualify if:

  • concomitant injuries to the dorsum of the injured finger
  • a defect \< 1.5 cm and\>3.5 cm in length
  • a finger degloving injury
  • the defect of the thumb

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Chen C, Tang P, Zhang L, Li X, Zheng Y. Repair of multiple finger defects using the dorsal homodigital island flaps. Injury. 2013 Nov;44(11):1582-8. doi: 10.1016/j.injury.2013.05.019. Epub 2013 Jun 28.

    PMID: 23810451BACKGROUND

MeSH Terms

Conditions

Finger 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

October 22, 2018

First Posted

October 24, 2018

Study Start

July 15, 2008

Primary Completion

May 10, 2016

Study Completion

July 30, 2016

Last Updated

October 24, 2018

Record last verified: 2018-06