Range of Motion Following Intraoperative Coban Dressing Application in Hand Burns
Primary Purpose
Burns, Hand Injuries
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
application of coban dressing
Sponsored by
About this trial
This is an interventional treatment trial for Burns focused on measuring Hand burn, skin graft, coban dressing, range of motion
Eligibility 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
Sites / Locations
- University of Missouri Health Care - George David Peak Memorial Burn Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention
Arm Description
Application of Coban dressing
Outcomes
Primary Outcome Measures
hand function(range of motion, grip and pinch strength)
Secondary Outcome Measures
graft success
Full Information
NCT ID
NCT01027520
First Posted
December 4, 2009
Last Updated
September 6, 2017
Sponsor
University of Missouri-Columbia
1. Study Identification
Unique Protocol Identification Number
NCT01027520
Brief Title
Range of Motion Following Intraoperative Coban Dressing Application in Hand Burns
Official Title
Day One Post Operative Range of Motion Following Skin Graft to Hand With Intraoperative Coban Dressing
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Why Stopped
Insufficient enrollment numbers
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Hand Injuries
Keywords
Hand burn, skin graft, coban dressing, range of motion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Application of Coban dressing
Intervention Type
Other
Intervention Name(s)
application of coban dressing
Other Intervention Name(s)
3M Coban Self-Adherent wrap
Intervention Description
application of a intraoperative coban dressing with reapplications following dressing removal.
Primary Outcome Measure Information:
Title
hand function(range of motion, grip and pinch strength)
Time Frame
post operative day four, first, second and third clinic visits
Secondary Outcome Measure Information:
Title
graft success
Time Frame
post operative day 4 and first, second and third clinic visits
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine L Barrow, BS OT
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri Health Care - George David Peak Memorial Burn Center
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Range of Motion Following Intraoperative Coban Dressing Application in Hand Burns
We'll reach out to this number within 24 hrs