NCT01486719

Brief Summary

Sensory reconstruction of the finger pulp is a challenging problem. This article reports repair of the finger pulp defect using the dorsal digital island flap. Both dorsal branches of the proper digital nerves (PDNs) were used for maximal sensory restoration.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2008

Typical duration 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

February 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2011

Completed
Last Updated

December 6, 2011

Status Verified

December 1, 2011

Enrollment Period

1.2 years

First QC Date

December 4, 2011

Last Update Submit

December 5, 2011

Conditions

Keywords

Finger pulp reconstructiondorsal branchproper digital nervepalmar arterial archdorsal digital island flap

Outcome Measures

Primary Outcomes (1)

  • static 2-point discrimination test

    The patients were assessed at follow-up by an independent senior surgeon who did not attend the treatments. Evaluation included active range of motion (ROM) of the DIP and proximal interphalangeal (PIP ) joints, and static 2-point discrimination (2PD) and Semmes-Weinstein monofilament test of the reconstructed finger pulps. These measurements were compared with those on the contralateral site. According to the Michigan Hand Outcomes Questionnaire (MHQ), patients reported their satisfaction with the appearance of the injured hand. The questions based on a 5-point response scale.

    Patients were followed for 16-23 months (mean, 19 months)

Secondary Outcomes (1)

  • Semmes-Weinstein monofilament test

    Patients were followed for 16-23 months (mean, 19 months)

Interventions

This article reports repair of the finger pulp defect using the dorsal digital island flap. Both dorsal branches of the proper digital nerves (PDNs) were used for maximal sensory restoration.

Also known as: Surgical Flap, Island Flap

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • a finger pulp defect \> 1.5 cm in length
  • necessity to preserve finger length
  • patients younger than 60 years .

You may not qualify if:

  • injury to the dorsum of the middle phalanx of the reconstructed finger that precluded its use as donor site
  • injury to the course of the vascular pedicle or opposite PDA
  • defects \< 1.5 cm in length.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Bene MD, Petrolati M, Raimondi P, Tremolada C, Muset A. Reverse dorsal digital island flap. Plast Reconstr Surg. 1994 Mar;93(3):552-7.

  • Pelissier P, Casoli V, Bakhach J, Martin D, Baudet J. Reverse dorsal digital and metacarpal flaps: a review of 27 cases. Plast Reconstr Surg. 1999 Jan;103(1):159-65. doi: 10.1097/00006534-199901000-00025.

  • Chen C, Tang P, Zhang X. Sensory reconstruction of a finger pulp defect using a dorsal homodigital island flap. Plast Reconstr Surg. 2012 Nov;130(5):1077-1086. doi: 10.1097/PRS.0b013e318267ef99.

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Surgical Flaps

Intervention Hierarchy (Ancestors)

Surgically-Created StructuresEquipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2011

First Posted

December 6, 2011

Study Start

February 1, 2008

Primary Completion

May 1, 2009

Study Completion

March 1, 2011

Last Updated

December 6, 2011

Record last verified: 2011-12