Range of Motion Following Intraoperative Coban Dressing Application in Hand Burns
Recruitment status was Not yet recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | December 4, 2009 | ||||||||
| Last Updated Date | December 7, 2009 | ||||||||
| Start Date ICMJE | January 2010 | ||||||||
| Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01027520 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
graft success [ Time Frame: post opeartive day 4 and first, second and third clinic visits ] [ Designated as safety issue: Yes ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Range of Motion Following Intraoperative Coban Dressing Application in Hand Burns | ||||||||
| Official Title ICMJE | Day One Post Operative Range of Motion Following Skin Graft to Hand With Intraoperative Coban Dressing | ||||||||
| 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? |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Other: application of coban dressing
application of a intraoperative coban dressing with reapplications following dressing removal.
Other Name: 3M Coban Self-Adherent wrap |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Estimated Completion Date | January 2012 | ||||||||
| Estimated Primary Completion Date | January 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01027520 | ||||||||
| Other Study ID Numbers ICMJE | cobandressing | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Catherine Lynn Barrow OTR/L, University of Missouri | ||||||||
| Study Sponsor ICMJE | University of Missouri-Columbia | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | University of Missouri-Columbia | ||||||||
| Verification Date | December 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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