Condition category
Surgery
Date applied
09/09/2018
Date assigned
19/09/2018
Last edited
15/10/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The finger pulp (flesh) plays an important role in tactile (touch) sensation. Restoring sensation to the finger pulp is essential for daily activities. Currently, sensory reconstruction of finger pulp defects remains a challenging task for plastic and hand surgeons. Some random-pattern skin flaps, such as thenar flap, conventional cross-finger flap, and abdominal flap, have been used for finger pulp reconstruction. Those flaps are easy to perform, but the flap transfer is not innervated (no nerve supply) and sensory recovery of the finger pulp is poor. The dorsal island pedicle flaps taken from the dorsum (back) of the adjacent finger are also used for finger pulp reconstruction. However, scar formation in the donor site is the major concern. Transfer of a free flap, such as free partial toe transfer, can achieve coverage with good texture match, but the procedures are cumbersome to perform, require small vessel anastomosis (cross-connection), and carry the risk of anastomosis failure. The aim of this study is to assess the use of a new cross-digital flap harvested from the dorsum of the thumb for reconstruction of finger pulp defects.

Who can participate?
Patients with finger pulp defects and exposed tendon or bone who require thumb pulp reconstruction for sensation

What does the study involve?
The cross-digital flap with nerve repair is performed on 36 patients. The sensitivity of the flap and the donor site, the degree of scarring, and the disability of the hand are assessed at 20 months after surgery.

What are the possible benefits and risks of participating?
Possible benefits include sensory reconstruction of the finger pulp defects which result in a better finger pulp function. Possible risks included flap loss and wound infection.

Where is the study run from?
Third Hospital of Hebei Medical University (China)

When is the study starting and how long is it expected to run for?
December 2014 to September 2017

Who is funding the study?
Third Hospital of Hebei Medical University (China)

Who is the main contact?
Dr Xu Zhang
ahand@sina.com

Trial website

Contact information

Type

Public

Primary contact

Dr Xu Zhang

ORCID ID

http://orcid.org/0000-0002-3383-2781

Contact details

Department of Hand Surgery
Third Hospital of Hebei Medical University
Shijiazhuang
050051
China
+86 (0)13933512651
ahand@sina.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

THHMU20181548

Study information

Scientific title

Reconstruction of finger pulp defects using the distally based cross-digital flap harvested from the dorsum of the thumb

Acronym

DBCDF

Study hypothesis

Reconstruction of finger pulp defects using the novel cross-digital flap harvested from the dorsum of the thumb results in 2PD less than 7 mm.

Ethics approval

Institutional review board of the Third Hospital of Hebei Medical University, 08/01/2015, THHMC20150364

Study design

Interventional non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Reconstruction of finger pulp defects

Intervention

The cross-digital flap with nerve repair was performed on 36 thumbs in 36 patients. The flap was a distally based neurovascular pedicle flap. The sensitivity of the flap and the donor site were tested using static 2-point discrimination. Scars were assessed the degree of scarring using the Vancouver scar scale. The Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire was used to assess the subjective disability of the hand.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Sensitivity of the flap and the donor site tested using static 2-point discrimination at 20 months after surgery

Secondary outcome measures

Subjective disability of the hand assessed using Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire at 20 months after surgery

Overall trial start date

15/12/2014

Overall trial end date

30/09/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. A finger pulp defect
2. Necessity of thumb pulp reconstruction for sensation
3. Exposed tendon or bone

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

36

Participant exclusion criteria

1. Injury to the dorsum of the thumb
2. Injury to the radial proper digital artery of the thumb or its dorsal branches

Recruitment start date

30/01/2015

Recruitment end date

15/07/2016

Locations

Countries of recruitment

China

Trial participating centre

Third Hospital of Hebei Medical University
Ziqiang Road, Shijiazhuang, Hebei
Shijiazhuang
050051
China

Sponsor information

Organisation

Third Hospital of Hebei Medical University

Sponsor details

Department of Hand Surgery
Shijiazhuang
050051
China
+86 (0)13933512651
ahand@sina.com

Sponsor type

University/education

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Third Hospital of Hebei Medical University

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a plastic or hand surgery journal.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

10/08/2019

Participant level data

To be made available at a later date

Basic results (scientific)

See additional file (ISRCTN33528751_BasicResults_15Oct18.pdf)

Publication list

Publication citations

Additional files

Editorial Notes

15/10/2018: The basic results of this trial have been uploaded as an additional file.