BurnsNCT01027520
Range of Motion Following Intraoperative Coban Dressing Application in Hand Burns
A study testing application of coban dressing in people with Burns and Hand Injuries, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burns, Hand Injuries
- What is being tested?
- application of coban dressing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Less than 15% burn, burn requires skin graft to dorsum of hand, burn involves at least 2 metacarpophalangeal joints
- 18 and older
Who cannot join
- Latex allergy
- Documented diagnoses of mental illness that interferes with patients ability to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Missouri Health Care - George David Peak Memorial Burn Center
Columbia, Missouri, 65212
About this study
Official title: Day One Post Operative Range of Motion Following Skin Graft to Hand With Intraoperative Coban Dressing
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?
Read the 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.
- Conditions
- Burns, Hand Injuries
- Being tested
- application of coban dressing
- Keywords
- Hand burn, skin graft, coban dressing, range of motion
- Medical subject headings
- Burns, Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
application of coban dressingOther
Also called 3M Coban Self-Adherent wrap
application of a intraoperative coban dressing with reapplications following dressing removal.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Application of Coban dressing Receives: Other: application of coban dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
hand function(range of motion, grip and pinch strength)
Measured: post operative day four, first, second and third clinic visits
Secondary outcomes (1)
graft success
Measured: post operative day 4 and first, second and third clinic visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2009 (estimated)
- Study startJan 2010
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: Insufficient enrollment numbers
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cathy Barrow, University of Missouri-Columbia
- Investigators
- Catherine L Barrow, BS OT, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027520
- Sponsor's protocol ID
- cobandressing
- Status last verified
- Sep 2016
- First submitted
- 4 Dec 2009
- Last updated
- 11 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Day One Post Operative Range of Motion Following Skin Graft to Hand With Intraoperative Coban Dressing
- ClinicalTrials.gov ID
- NCT01027520
- Acronym / sponsor ID
- cobandressing
- Conditions
- Burns, Hand Injuries
- Keywords
- Hand burn, skin graft, coban dressing, range of motion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment numbers
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 8 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: application of coban dressingApplication of Coban dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Less than 15% burn, burn requires skin graft to dorsum of hand, burn involves at least 2 metacarpophalangeal joints
- 18 and older
Key exclusion criteria (2 listed)
- Latex allergy
- Documented diagnoses of mental illness that interferes with patients ability to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| application of coban dressingAlso: 3M Coban Self-Adherent wrapapplication of a intraoperative coban dressing with reapplications following dressing removal. | Other | Intervention |
Primary outcome
hand function(range of motion, grip and pinch strength)
Time frame: post operative day four, first, second and third clinic visits
1 secondary outcome
graft success
Time frame: post operative day 4 and first, second and third clinic visits
Results and safety
The study was stopped early (reason given: Insufficient enrollment numbers). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine L Barrow, BS OT principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing application of coban dressing in people with Burns and Hand Injuries, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient enrollment numbers). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hand function(range of motion, grip and pinch strength) (time frame: post operative day four, first, second and third clinic visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2017.