NCT02659449

Brief Summary

The purpose of this study is to determine the impact of compressing therapy on the dexterity of burned hands using evaluating hand function tests (Box and block / Purdue Peg Board / Jamar's test)

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 20, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

June 23, 2016

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

10 days

First QC Date

October 27, 2015

Last Update Submit

July 22, 2022

Conditions

Keywords

hands

Outcome Measures

Primary Outcomes (3)

  • Box and Block test

    A rectangular box that is divided into two square compartments of equal dimension by means of a partition. One hundred and fifty, wooden cubes are placed in one compartment or the other. The individual move as many blocks as possible, one at a time, from one compartment to the other for a period of 60 seconds. The BBT is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period. The measure will be implemented for each compressive medical device and free hand (three time for each patient). Interval of 24h between each compressive. Measure will be realised at end of test when hand's cicatrisation will be obtained and after a time lag of 7 days after receipt of definitive compressive gloves. The measure will be realised every two days during one week (duration of study after inclusion of patient) after hand's evaluation by the investigator.

    mesure will be realised three time : 48h - 96h -144 hours after inclusion

  • Purdue Pegboard test

    The Purdue Pegboard Test is a rectangular board with 2 sets of 25 holes running vertically and 4 concave cups at the top. Small metal pegs are placed in the cup on the side being tested, with subjects asked to remove the pegs and place them vertically in the holes as rapidly as possible. The number of pegs placed in 30 seconds is scored. The measure will be implemented for each compressive medical device and free hand (three time for each patient). Interval of 24h between each compressive. Measure will be realised at end of test when hand's cicatrisation will be obtained and after a time lag of 7 days after receipt of definitive compressive gloves. the measure will be realised every two days during one week (duration of study) after hand's evaluation by the investigator

    mesure will be realised three time: 48h - 96h -144 hours after inclusion

  • Jamar's Test

    A Hand Dynamometer is used for testing hand grip strength. The measure will be implemented for each compressive medical device and free hand (three time for each patient). Interval of 24h between each compressive. Measure will be realised at the hand of the test when hand's cicatrisation will be obtained and after a time lag of 7 days after receipt of definitive compressive gloves. the measure will be realised every two days during one week (duration of study) after hand's evaluation by the investigator

    mesure will be realised three time :48h - 96h -144 hours after inclusion

Secondary Outcomes (1)

  • Quick DASH test

    24 hours after inclusion

Interventions

Patients achieve tests with compression glove

Also known as: gloves of medical Z laboratory

Patients achieve tests with compression bandaging

Also known as: Coheban

Patients achieve tests without device

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with burned hands

You may qualify if:

  • Patient admitted from Leon Bérard Hospital
  • Burn hand with 2nd or 3nd degree depp
  • Dominant hand if bilateral's burning
  • Patients requiring compression of the hand
  • Patient receiving final compression gloves since seven days ± two days weekend
  • Patient affiliated to a social security

You may not qualify if:

  • No burning of the hand
  • contraindication for the use of compression
  • Incompatible articular balance with achievement tests
  • Patients already included in a second study
  • Minor patient or pregnant woman
  • Presence of cognitive disorder, preventing the achievement of tests
  • Guardianship or individual under the protection of a conservator
  • Patients not receiving social security

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leon Berard hospital

Hyères, PACA, 83418, France

Location

MeSH Terms

Interventions

Compression Bandages

Intervention Hierarchy (Ancestors)

BandagesEquipment and Supplies

Study Officials

  • Valerie Chavineau-Mortelette, MedD

    Léon Bérard Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2015

First Posted

January 20, 2016

Study Start

June 23, 2016

Primary Completion

July 3, 2016

Study Completion

December 1, 2016

Last Updated

July 26, 2022

Record last verified: 2022-07

Locations