BurnsACTNCT01161810
The Relationship of Rehabilitation Therapy Time To The Prevention of Burn Scar Contracture
An observational study of Burns, run by American Burn Association at 14 sites in United States.
Trial summary
This project will develop a descriptive database of patient information and patient outcomes. This database will be used to determine the association of time spent in rehabilitation and patient outcomes, to relate patient acuity to burn scar contracture development and to establish minimal time requirement guidelines… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Burns
- What is being tested?
- Routine post burn rehabilitation therapy
- How many people
- 386 participants
- Where
- 14 sitesUnited States
- Study dates
- Jul 2010to Sep 2014
- Phase
- Observational
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary diagnosis of acute burn injury
Who may be able to join
- 18 year of age or older
- Admission for primary diagnosis of cutaneous burn injury
- Anticipated length of stay equal to/greater than five days
- >2% deep partial thickness burn OR hand burn (which may be less than 2% deep partial thickness burn)
Who cannot join
- Non-survivable burn as determined by the attending burn surgeon
- Electrical burn injury
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27514
U.S. army Institute of Surgical Research
Fort Sam Houston, Texas, 78234-6315
St. Joseph Regional Burn Center
Fort Wayne, Indiana, 46802
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
St Elizabeth Regional Medical Center
Lincoln, Nebraska, 68510
Loyola University Health System
Maywood, Illinois, 60153
NewYork-Presbyterian Weill Cornell Medical Center
New York, New York, 10065
University of Califronia Irvine
Orange, California, 92868
Arizona Burn Center
Phoenix, Arizona, 85008
Oregon Burn Center, Legacy Emanuel Hospital & Health Center
Portland, Oregon, 97232
University of California Davis, Regional Burn Center
Sacramento, California, 95817
Regions Hospital Burn Center
Saint Paul, Minnesota, 55101
University of Utah Health Services Center
Salt Lake City, Utah, 84132
Via Christi Regional Burn Center
Wichita, Kansas, 67214
About this study
Official title: Burn Patient Acuity Demographics, Scar Contractures and Rehabilitation Treatment Time Related to Patient Outcomes (ACT)
This project will develop a descriptive database of patient information and patient outcomes. This database will be used to determine the association of time spent in rehabilitation and patient outcomes, to relate patient acuity to burn scar contracture development and to establish minimal time requirement guidelines for various rehabilitation patient outcomes.
- Conditions
- Burns
- Being tested
- Routine post burn rehabilitation therapy
- Keywords
- Burn, Rehabilitation
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine post burn rehabilitation therapyOther
No testing outside of routine clinical rehabilitation will be performed
| Study group | Role | What they receive |
|---|---|---|
| Post-Burn Rehabilitation | Patients with an acute burn injury who are admitted to the hospital with anticipated length of stay of 5 days or greater Receives: Other: Routine post burn rehabilitation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure patient outcome in terms of time devoted to rehabilitation
Standard information that is recorded as part of daily routine in the rehabilitation treatment of patients with burn injury will be used as data to analyze patient outcomes
Measured: At discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionApr 2014
- Study completionSep 2014
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 386 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Burn Association
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
- Investigators
- Reginald L Richard, MS, PT, Principal investigator, U.S. Army Institute of Surgical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161810
- Sponsor's protocol ID
- ABA-MCTG-0003
- Other IDs
- H-08-028
- Acronym
- ACT
- Status last verified
- Aug 2023
- First submitted
- 12 Jul 2010
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Burn Patient Acuity Demographics, Scar Contractures and Rehabilitation Treatment Time Related to Patient Outcomes (ACT)
- ClinicalTrials.gov ID
- NCT01161810
- Acronym / sponsor ID
- ACT / ABA-MCTG-0003
- Conditions
- Burns
- Keywords
- Burn, Rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- American Burn AssociationUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- Jul 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 14 Jul 2010 (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.
This project will develop a descriptive database of patient information and patient outcomes. This database will be used to determine the association of time spent in rehabilitation and patient outcomes, to relate patient acuity to burn scar contracture development and to establish minimal time requirement guidelines for various rehabilitation patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Post-Burn Rehabilitation | – | Other: Routine post burn rehabilitation therapyPatients with an acute burn injury who are admitted to the hospital with anticipated length of stay of 5 days or greater |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary diagnosis of acute burn injury
Key inclusion criteria (4 listed)
- 18 year of age or older
- Admission for primary diagnosis of cutaneous burn injury
- Anticipated length of stay equal to/greater than five days
- >2% deep partial thickness burn OR hand burn (which may be less than 2% deep partial thickness burn)
Key exclusion criteria (2 listed)
- Non-survivable burn as determined by the attending burn surgeon
- Electrical burn injury
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 |
|---|---|---|
| Routine post burn rehabilitation therapyNo testing outside of routine clinical rehabilitation will be performed | Other | Post-Burn Rehabilitation |
Primary outcome
Measure patient outcome in terms of time devoted to rehabilitation
Time frame: At discharge
Standard information that is recorded as part of daily routine in the rehabilitation treatment of patients with burn injury will be used as data to analyze patient outcomes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
Related trials for Burns
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Sepsis, Sepsis-induced Coagulopathy
Not yet recruitingObservational study
Hypertrophic Scar Prosthetic Pressure in Burn Amputee
Amputation Stump, Burn Injury
Not yet recruiting
Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children
Burn Injury, Procedural Anxiety
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
RecruitingPhase 2
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
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.
Reginald L Richard, MS, PT principal investigator
U.S. Army Institute of Surgical Research
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burns, run by American Burn Association at 14 sites 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 4 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: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measure patient outcome in terms of time devoted to rehabilitation (time frame: At discharge). 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 4 Aug 2023.