Hypertrophic Scarring After Burn InjuryNCT01005732
Effectiveness of Pressure Garment Therapy After Burns
A study testing Custom fabricated pressure garments in people with Hypertrophic Scarring After Burn Injury, run by University of Washington at 1 site in United States.
Trial summary
Purpose - To determine the effectiveness of custom-fit pressure garment therapy in the prevention of hypertrophic scarring in healed burns. Background - Approximately one million people are burned each year in the United States. Read more about this study
- Who is it for?
- Ages 7 to 65 years
- Conditions the study is for
- Hypertrophic Scarring After Burn Injury
- What is being tested?
- Custom fabricated pressure garments
- Type of treatment
- Medical device
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 1995to Sep 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 7 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Treated from time of burn at the University of Washington Burn Center during the first two years of the grant period
- Burns covering the majority of the forearm that healed spontaneously in three or more weeks. Patients will be entered into the study within 4 weeks of injury.
- Age 7-65 years. Patients younger than 7 years will be excluded given the cooperation required during follow-up evaluations. Patients over 65 years will be excluded since the incidence of hypertrophic scarring in persons over 65 is too low to warrant pressure garment trials.
- Patients of any race, ethnicity, or skin color.
- Informed, written consent in accord with the rules of the Human Subjects Committee of the University of Washington and the Health Insurance Portability and Accountability Act (HIPAA).
Who cannot join
- Incarcerated patients
- Homeless patients
- Patients with substance abuse
- Patients with psychiatric diagnosis
- Patients unavailable to return regularly for follow-up evaluations
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Burn Center
Seattle, Washington, 98104
About this study
Purpose - To determine the effectiveness of custom-fit pressure garment therapy in the prevention of hypertrophic scarring in healed burns.
Background - Approximately one million people are burned each year in the United States. The most devastating outcomes following burns is the ugly, itchy, hypertrophic scar that interferes with work and all other aspects of life. Pressure garment therapy is routinely used to minimize hypertrophic scarring even though there is no scientifically valid data that this therapy is efficacious. Pressure garments are extremely unattractive, expensive and uncomfortable and their use needs to be based upon valid data.
Read more
Goals and Objectives - The investigators plan to determine the effectiveness of pressure garment therapy in the control of hypertrophic scarring in healed burns.
Methods - The I-Scan® device was designed to measure pressure at the body/environment interface and allows clinicians to deal with pressure-related problems for at-risk patients. It has been widely used in rehabilitation medicine but not with burn survivors. The investigators will use this device to measure the pressure at the garment/skin interface. 2) Furthermore, the few studies that have been attempted to determine efficacy have used between subjects designs. Since burn depth is extremely variable from patient to patient and since hypertrophic scarring is greatly influenced by age and race/origin, the between subjects design requires very large numbers of subjects. The investigators will use a within wounds design studying forearm burns and applying pressure to half of the wound and no pressure to the other half. The investigators will then compare hardness, color, thickness and clinical appearance.
- Conditions
- Hypertrophic Scarring After Burn Injury
- Being tested
- Custom fabricated pressure garments
- Keywords
- hypertrophic, scar, burn, cicatrix, pressure, garment
- Medical subject headings
- Hypertrophy, Cicatrix, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom fabricated pressure garmentsDevice
Also called Medical Z (Medical Z, San Antonio, TX)
Cloth garments designed to apply 17-24 mmHg pressure to the 1/2 the burn wound and <5 mmHg to the other half, to be worn 23 hours per day until wounds mature, approximately 12 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Under Compression Garment
Pressure measurements were obtained at the scar/garment interface using the I-ScanTM System (Tekscan, Inc., South Boston, MA). The device was calibrated and the pressure determined in mmHg. Pressure measurements were obtained by a therapist not involved in the care of the patient, who was trained in the use of the device. Therefore pressure ''dose'' was measured directly. Values reported are averaged over indicated visits.
Measured: Approximately 2.5, 5, 7.5, 10, and 12 months (follow-up visits 1-5)
Secondary outcomes (5)
Durometer (Hardness) of Wound
A single Rex Durometer Hand Model 1600, Type 00, without a foot attachment (Rex Gauge Company Inc., Glenview, IL) was used to measure scar hardness throughout the study. This device measures hardness of light foams, sponge rubber gels, and animal tissue in "durometer units" (range 0=soft, 100=hard). Measurements were obtained with the person in the sitting position with the forearm supported in a horizontal position on a desk and the shoulder adducted. The area of interest was triangulated and measurements obtained at the corners were averaged; the sides of the triangle were 3-5 cm.
Measured: Approximately 2.5, 5, 7.5, 10, and 12 months (follow-up visits 1-5)
Color of Wound
A Chromameter Minolta CR-300 (Konica Minolta, Ramsey, NJ) measured skin color. Skin surface illuminated by pulsed xenon arc lamp. Light reflected perpendicular to surface collected for a tri-stimulus color analysis. One measurement consisted of three flashes of illumination in order to obtain a mean value. Measurement values are in the L*a*b* color space was described by The Commission Internationale de I'Eclairage (CIE)(L=brightness [100=white,0=black], a=red-green[red=60,green=-60], b=yellow-blue[yellow=60,blue=-60])
Measured: Approximately12 months (follow-up visits 5)
Thickness of Wound
Scar thickness in millimeters was obtained with high-frequency ultrasonography in the Department of Radiology. Several machines and probes were used over the years each with accuracy to 0.5 mm. The area of interest was triangulated and measurements obtained at the corners were averaged; the sides of the triangle were 3-5 cm.
Measured: Approximately 12 months (follow-up visit 5)
Clinical Appearance of Wound
Photographs of wounds showed final cosmetic result. The two compression areas for each photograph were labeled distal (D) and proximal (P). We asked 11 experts (blinded as to the compression of the rated zones) to judge which zone (D or P) had the better cosmetic appearance or whether there was no difference. Votes were tallied according to the unblinded compression zone (i.e., high/normal and low). We report number of participants for which the rating experts all agreed or did not all agree (i.e., voted the other zone or "no difference") that the indicated zone had the better appearance.
Measured: Approximately 12 months (follow-up visit 5)
Compliance With Wearing Compression Garment
The patients were asked to complete a compliance form indicating how many hours the garment was worn each day.
Measured: About 12 months (follow-up visit 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2009 (estimated)
- Study startNov 1995
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertrophic Scarring After Burn InjuryStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Investigators
- Loren Engrav, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01005732
- Sponsor's protocol ID
- 30336-B
- Other IDs
- H133G050022, NIDRR_UWashingtonBMS_pgarment
- Status last verified
- Apr 2011
- First submitted
- 30 Oct 2009
- Last updated
- 4 Apr 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Engrav LH, Heimbach DM, Rivara FP, Moore ML, Wang J, Carrougher GJ, Costa B, Numhom S, Calderon J, Gibran NS. 12-Year within-wound study of the effectiveness of custom pressure garment therapy. Burns. 2010 Nov;36(7):975-83. doi: 10.1016/j.burns.2010.04.014. Epub 2010 Jul 1.
PubMed 20537469
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pressure Garment Therapy After Burns
- ClinicalTrials.gov ID
- NCT01005732
- Acronym / sponsor ID
- 30336-B
- Conditions
- Hypertrophic Scarring After Burn Injury
- Keywords
- hypertrophic, scar, burn, cicatrix, pressure, garment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Nov 1995
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 2 Nov 2009 (estimated)
- Results
- Posted 4 Apr 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose - To determine the effectiveness of custom-fit pressure garment therapy in the prevention of hypertrophic scarring in healed burns.
Background - Approximately one million people are burned each year in the United States. The most devastating outcomes following burns is the ugly, itchy, hypertrophic scar that interferes with work and all other aspects of life. Pressure garment therapy is routinely used to minimize hypertrophic scarring even though there is no scientifically valid data that this therapy is efficacious. Pressure garments are extremely unattractive, expensive and uncomfortable and their use needs to be based upon valid data.
Goals and Objectives - The investigators plan to determine the effectiveness of pressure garment therapy in the control of hypertrophic scarring in healed burns.
Methods - The I-Scan® device was designed to measure pressure at the body/environment interface and allows clinicians to deal with pressure-related problems for at-risk patients. It has been widely used in rehabilitation medicine but not with burn survivors. The investigators will use this device to measure the pressure at the garment/skin interface. 2) Furthermore, the few studies that have been attempted to determine efficacy have used between subjects designs. Since burn depth is extremely variable from patient to patient and since hypertrophic scarring is greatly influenced by age and race/origin, the between subjects design requires very large numbers of subjects. The investigators will use a within wounds design studying forearm burns and applying pressure to half of the wound and no pressure to the other half. The investigators will then compare hardness, color, thickness and clinical appearance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 7 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Treated from time of burn at the University of Washington Burn Center during the first two years of the grant period
- Burns covering the majority of the forearm that healed spontaneously in three or more weeks. Patients will be entered into the study within 4 weeks of injury.
- Age 7-65 years. Patients younger than 7 years will be excluded given the cooperation required during follow-up evaluations. Patients over 65 years will be excluded since the incidence of hypertrophic scarring in persons over 65 is too low to warrant pressure garment trials.
- Patients of any race, ethnicity, or skin color.
- Informed, written consent in accord with the rules of the Human Subjects Committee of the University of Washington and the Health Insurance Portability and Accountability Act (HIPAA).
Key exclusion criteria (5 listed)
- Incarcerated patients
- Homeless patients
- Patients with substance abuse
- Patients with psychiatric diagnosis
- Patients unavailable to return regularly for follow-up evaluations
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 |
|---|---|---|
| Custom fabricated pressure garmentsAlso: Medical Z (Medical Z, San Antonio, TX)Cloth garments designed to apply 17-24 mmHg pressure to the 1/2 the burn wound and <5 mmHg to the other half, to be worn 23 hours per day until wounds mature, approximately 12 months | Device | – |
Primary outcome
Pressure Under Compression Garment
Time frame: Approximately 2.5, 5, 7.5, 10, and 12 months (follow-up visits 1-5)
Pressure measurements were obtained at the scar/garment interface using the I-ScanTM System (Tekscan, Inc., South Boston, MA). The device was calibrated and the pressure determined in mmHg. Pressure measurements were obtained by a therapist not involved in the care of the patient, who was trained in the use of the device. Therefore pressure ''dose'' was measured directly. Values reported are averaged over indicated visits.
5 secondary outcomes
Durometer (Hardness) of Wound
Time frame: Approximately 2.5, 5, 7.5, 10, and 12 months (follow-up visits 1-5)
Color of Wound
Time frame: Approximately12 months (follow-up visits 5)
Thickness of Wound
Time frame: Approximately 12 months (follow-up visit 5)
Clinical Appearance of Wound
Time frame: Approximately 12 months (follow-up visit 5)
Compliance With Wearing Compression Garment
Time frame: About 12 months (follow-up visit 5)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20537469Engrav LH, Heimbach DM, Rivara FP, Moore ML, Wang J, Carrougher GJ, Costa B, Numhom S, Calderon J, Gibran NS. 12-Year within-wound study of the effectiveness of custom pressure garment therapy. Burns. 2010 Nov;36(7):975-83. doi: 10.1016/j.burns.2010.04.014. Epub 2010 Jul 1.
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.
Loren Engrav principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom fabricated pressure garments in people with Hypertrophic Scarring After Burn Injury, run by University of Washington 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 4 Apr 2011. 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?
Yes. Results are posted in the registry (first posted 4 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pressure Under Compression Garment (time frame: Approximately 2.5, 5, 7.5, 10, and 12 months (follow-up visits 1-5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01005732, which also lists 1 linked publication.
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 4 Apr 2011; AzTrials last refreshed its copy on 6 Nov 2026.