Range of Motion Following Intraoperative Coban Dressing Application in Hand Burns

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by University of Missouri-Columbia.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT01027520
First received: December 4, 2009
Last updated: December 7, 2009
Last verified: December 2009
  Purpose

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?


Condition Intervention
Burns
Hand Injuries
Other: application of coban dressing

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Day One Post Operative Range of Motion Following Skin Graft to Hand With Intraoperative Coban Dressing

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • hand function(range of motion, grip and pinch strength) [ Time Frame: post operative day four, first, second and third clinic visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • graft success [ Time Frame: post opeartive day 4 and first, second and third clinic visits ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: January 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: application of coban dressing
    application of a intraoperative coban dressing with reapplications following dressing removal.
    Other Name: 3M Coban Self-Adherent wrap
Detailed Description:

The participant will be evaluated by occupational therapist prior to surgery. The coban dressing will be applied to the participant's hand(s)during surgery for a skin graft. This portion will occur whether the participant agrees to participate or not. The participant will begin range of motion exercises the day after surgery (post operative day one) with and occupational therapist. The occupational therapist will see the participant daily for supervised range of motion while in the hospital. The coban dressing will be removed on post operative day one if a sheet graft is placed to assess bleeding under graft. The coban dressing will be reapplied and removed again on post operative day four. When a meshed graft is placed, coban dressing will be removed on post operative day four only. All skin grafts (meshed and sheet grafts) and range of motion will be assessed on post operative day four. Coban dressing will be reapplied. The participant will continue range of motion exercise program at home. An appointment will be scheduled for 3 consecutive weeks in out patient burn clinic. During clinic visits, skin graft, range of motion, and grip strength will be measured. The participant will seen in out patient burn clinic whether they choose to participate in the study or not as a standard of burn care.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Latex allergy
  • Documented diagnoses of mental illness that interferes with patients ability to participate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01027520

Contacts
Contact: Catherine Lynn Barrow, BS OT 573-882-8706 barrowc@health.missouri.edu
Contact: Whitney Lee Henderson, MS OT 573-882-8706 hendersonwl@health.missouri.edu

Locations
United States, Missouri
University of Missouri Health Care - George David Peak Memorial Burn Center Not yet recruiting
Columbia, Missouri, United States, 65212
Contact: Catherine Lynn Barrow, BS OT    573-882-8706    barrowc@health.missouri.edu   
Contact: Whitney Lee Henderson, MS OT    573-882-8706    hendersonwl@health.missouri.edu   
Sub-Investigator: Whitney Lee Henderson, MS OT         
Sponsors and Collaborators
University of Missouri-Columbia
  More Information

No publications provided

Responsible Party: Catherine Lynn Barrow OTR/L, University of Missouri
ClinicalTrials.gov Identifier: NCT01027520     History of Changes
Other Study ID Numbers: cobandressing
Study First Received: December 4, 2009
Last Updated: December 7, 2009
Health Authority: University of Missouri, USA: Health Science Institutional Review Board

Keywords provided by University of Missouri-Columbia:
Hand burn
skin graft
coban dressing
range of motion
Does initiation of range of motion on post operative day one improve hand function without compromising graft success.

Additional relevant MeSH terms:
Burns
Hand Injuries
Wounds and Injuries
Monensin
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Coccidiostats
Proton Ionophores
Uncoupling Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Ionophores
Membrane Transport Modulators
Sodium Ionophores

ClinicalTrials.gov processed this record on August 01, 2014