BurnsPhase 2/3JobstNCT00675974
Use of Pressure Garments for Burn Scars
A Phase 2/3 study testing Jobst Pressure Garment and Medical Z pressure garment in people with Burns, run by The University of Texas Medical Branch, Galveston.
Trial summary
1. Will Pressure Garment Therapy better control hypertrophic scarring than no Pressure Garment Therapy. 2. How will Pressure Garment Therapy affect functional capacity or scar contracture development across joints either in number or severity. 3. Will Pressure Garment Therapy diminish discomfort due to pruritus. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Burns
- What is being tested?
- Jobst Pressure Garment and Medical Z pressure garment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2005to Dec 2014
- Phase
- Phase 2/3
- 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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- At least 30% total body surface area(TBSA) second degree burns or at least 10% TBSA full-thickness burns including bilateral comparable burns to upper and/or lower extremities.
- at least 1 year of age and no more than 17 years of age
- Wound closure
- No evidence of deep venous thrombosis or other vascular compromise.
- No concomitant conflicting study protocols.
Who cannot join
- Burn injuries not bilateral to upper and/or lower extremities.
- Evidence of vascular compromise.
- Conflicting protocols.
About this study
Official title: Prospective Randomized Study of the Effectiveness of Prospective Randomized Study on the Effectiveness of Pressure Garment Therapy for the Prevention of Hypertrophic Scarring in Burned Children
- Will Pressure Garment Therapy better control hypertrophic scarring than no Pressure Garment Therapy.
- How will Pressure Garment Therapy affect functional capacity or scar contracture development across joints either in number or severity.
- Will Pressure Garment Therapy diminish discomfort due to pruritus.
- Conditions
- Burns
- Being tested
- Jobst Pressure Garment, Medical Z pressure garment
- Keywords
- Burn, Scar, Pressure garments, Wound healing, Burn Injury
- Medical subject headings
- Burns, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jobst Pressure GarmentDevice
Also called Jobst pressure garments, Medical Z pressure garments, Pressure garments
Pressure garment therapy for 18 months post burn injury. May be Jobst pressure garment or Medical Z pressure garment.
Medical Z pressure garmentDevice
Also called Pressure garment, Jobst pressure garment
Pressure garment to be worn for 18 months post burn. May be Jobst pressure garment or Medical Z pressure garment.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Pressure garment therapy Receives: Device: Jobst Pressure Garment; Device: Medical Z pressure garment |
| 2 | No intervention | No pressure garment therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in scarring between pressure garment therapy and no pressure garment therapy
Measured: Time of burn to 2 years post burn
Secondary outcomes (2)
Effect of Pressure Garment Therapy on functional capacity or scar contracture development across joints either in number or severity compared to no pressure garment therapy.
Measured: Time of burn to 2 years post burn
Effect of pressure garment therapy on scar discomfort and pruritis compared to no pressure garment therapy
Measured: Time of burn to 2 years post burn
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2008 (estimated)
- Study startAug 2005
- Primary completionDec 2012 (estimated)
- Study completionDec 2014 (estimated)
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 The University of Texas Medical Branch, GalvestonThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
- Responsible party
- Sponsor
- Investigators
- David N Herndon, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675974
- Sponsor's protocol ID
- 05-126
- Other IDs
- NIDRR
- Acronym
- Jobst
- Status last verified
- Nov 2012
- First submitted
- 26 Dec 2007
- Last updated
- 15 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Study of the Effectiveness of Prospective Randomized Study on the Effectiveness of Pressure Garment Therapy for the Prevention of Hypertrophic Scarring in Burned Children
- ClinicalTrials.gov ID
- NCT00675974
- Acronym / sponsor ID
- Jobst / 05-126
- Conditions
- Burns
- Keywords
- Burn, Scar, Pressure garments, Wound healing, Burn Injury
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- Aug 2005
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 12 May 2008 (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.
- Will Pressure Garment Therapy better control hypertrophic scarring than no Pressure Garment Therapy.
- How will Pressure Garment Therapy affect functional capacity or scar contracture development across joints either in number or severity.
- Will Pressure Garment Therapy diminish discomfort due to pruritus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Jobst Pressure Garment, Device: Medical Z pressure garmentPressure garment therapy |
| 2 | No intervention | –No pressure garment therapy |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- At least 30% total body surface area(TBSA) second degree burns or at least 10% TBSA full-thickness burns including bilateral comparable burns to upper and/or lower extremities.
- at least 1 year of age and no more than 17 years of age
- Wound closure
- No evidence of deep venous thrombosis or other vascular compromise.
- No concomitant conflicting study protocols.
Key exclusion criteria (3 listed)
- Burn injuries not bilateral to upper and/or lower extremities.
- Evidence of vascular compromise.
- Conflicting protocols.
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 |
|---|---|---|
| Jobst Pressure GarmentAlso: Jobst pressure garments, Medical Z pressure garments, Pressure garmentsPressure garment therapy for 18 months post burn injury. May be Jobst pressure garment or Medical Z pressure garment. | Device | 1 |
| Medical Z pressure garmentAlso: Pressure garment, Jobst pressure garmentPressure garment to be worn for 18 months post burn. May be Jobst pressure garment or Medical Z pressure garment. | Device | 1 |
Primary outcome
Differences in scarring between pressure garment therapy and no pressure garment therapy
Time frame: Time of burn to 2 years post burn
2 secondary outcomes
Effect of Pressure Garment Therapy on functional capacity or scar contracture development across joints either in number or severity compared to no pressure garment therapy.
Time frame: Time of burn to 2 years post burn
Effect of pressure garment therapy on scar discomfort and pruritis compared to no pressure garment therapy
Time frame: Time of burn to 2 years post burn
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2012.
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Pruritis
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.
David N Herndon, MD principal investigator
University of Texas
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Jobst Pressure Garment and Medical Z pressure garment in people with Burns, run by The University of Texas Medical Branch, Galveston.
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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 15 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Differences in scarring between pressure garment therapy and no pressure garment therapy (time frame: Time of burn to 2 years post burn). 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 15 Nov 2012.