NCT01027520

Brief Summary

Participants of this study will include burns requiring skin graft to hand(s). After informed consent, an occupational therapy evaluation will be performed. Participants will consent to surgery, in which skin graft will be applied by physician during surgery, occupational therapy will apply coban dressing. Participant will seen daily by occupational therapist during hospitalization for active range of motion to hand(s). Occupational therapist will measure range of motion of hand(s) and physician will assess graft success at one and four days after surgery and at three out patient clinic visits. Hand strength will also be measured at three out patient visits. Does the initiation of range of motion on post operative day kone with coban dressing improve hand function without compromising graft success?

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

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

December 4, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 8, 2009

Completed
24 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2016

Enrollment Period

1.9 years

First QC Date

December 4, 2009

Last Update Submit

September 6, 2017

Conditions

Keywords

Hand burnskin graftcoban dressingrange of motion

Outcome Measures

Primary Outcomes (1)

  • hand function(range of motion, grip and pinch strength)

    post operative day four, first, second and third clinic visits

Secondary Outcomes (1)

  • graft success

    post operative day 4 and first, second and third clinic visits

Study Arms (1)

Intervention

EXPERIMENTAL

Application of Coban dressing

Other: application of coban dressing

Interventions

application of a intraoperative coban dressing with reapplications following dressing removal.

Also known as: 3M Coban Self-Adherent wrap
Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Less than 15% burn, burn requires skin graft to dorsum of hand, burn involves at least 2 metacarpophalangeal joints
  • and older

You may not qualify if:

  • Latex allergy
  • Documented diagnoses of mental illness that interferes with patients ability to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri Health Care - George David Peak Memorial Burn Center

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

BurnsHand Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Catherine L Barrow, BS OT

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Occupational Therapist

Study Record Dates

First Submitted

December 4, 2009

First Posted

December 8, 2009

Study Start

January 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

September 11, 2017

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations