Burn InjuryNCT04417439
The Effect of Acute Phase Treatment Approaches on Creatine Kinase and the Musculoskeletal System in Different Types of Burns
An observational study of Burn Injury, run by Inonu University at 2 sites in Turkey (Türkiye).
Trial summary
There are very few studies indicating the effect of acute phase treatment approaches on creatine kinase and the musculoskeletal system in the physiotherapy and rehabilitation process. Rehabilitation in burn patients is a benchmark due to return to pre-burn life. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Burn Injury
- What is being tested?
- universal goniometer. evaluate the circumference measurement. The biochemical examination of CK (creatine kinase)
- How many people
- 37 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 12 May 2018to 31 May 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 37 individuals, including 10 females and 27 males
Who may be able to join
- the study were being aged between 18-65 years and having different burn types, and flame, scald, and electrical burns were included in the study.
- The burn percentage and mortality percentage were calculated, and patients with a burn percentage of less than fifty percent were included.
Who cannot join
- the study were having a systemic disease, having substance abuse, and having a burn percentage of more than fifty percent.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Malatya İnönü University
Malatya, 44000
Turgut Özal medical center
Malatya, 44280
About this study
Official title: Turgut Özal Medical Center
There are very few studies indicating the effect of acute phase treatment approaches on creatine kinase and the musculoskeletal system in the physiotherapy and rehabilitation process. Rehabilitation in burn patients is a benchmark due to return to pre-burn life. Therefore, this study was conducted to determine the effect of acute phase treatment approaches on creatine kinase and the musculoskeletal system in different types of burns.
Read the detailed description
In the literature, there are very few objective and quantitative studies comparing the effects of standard wound care and rehabilitation period on different burn types in burn patients. Thus, our study was designed to investigate the effects of acute phase treatment approaches on creatine kinase and the musculoskeletal system in different types of burns.
- Conditions
- Burn Injury
- Being tested
- universal goniometer. evaluate the circumference measurement. The biochemical examination of CK (creatine kinase)
- Keywords
- Acute-phase burn, Creatine Kinase, MM Form,, Musculoskeletal Development, Treatment Effectiveness
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
universal goniometer. evaluate the circumference measurement. The biochemical examination of CK (creatine kinase)Other
The joint range of motion within the affected areas of burn patients was assessed by a universal goniometer. A 7-mm-wide tape measure was used to evaluate circumference measurement in individuals. The biochemical analysis of CK (creatine kinase) was performed by an expert on blood samples taken from patients in the hospital laboratories.
| Study group | Role | What they receive |
|---|---|---|
| flame burns | The joint range of motion was assessed by a universal goniometer within the affected areas of burn patients. A tape measure with a width of 7 mm was used to evaluate the circumference measurement in individuals. The biochemical examination of CK (creatine kinase) was performed in the laboratories. Receives: Other: universal goniometer. evaluate the circumference measurement. The biochemical examination of CK (creatine kinase) | |
| scald burns | The joint range of motion was assessed by a universal goniometer within the affected areas of burn patients. A tape measure with a width of 7 mm was used to evaluate the circumference measurement in individuals. The biochemical examination of CK (creatine kinase) was performed in the laboratories. Receives: Other: universal goniometer. evaluate the circumference measurement. The biochemical examination of CK (creatine kinase) | |
| electrical burns | The joint range of motion was assessed by a universal goniometer within the affected areas of burn patients. A tape measure with a width of 7 mm was used to evaluate the circumference measurement in individuals. The biochemical examination of CK (creatine kinase) was performed in the laboratories. Receives: Other: universal goniometer. evaluate the circumference measurement. The biochemical examination of CK (creatine kinase) |
What is being measured
The primary outcome is the main question the study is designed to answer.
universal goniometer
Universal goniometer was used to measure arm flexion movement.
Measured: three weeks
A tape measure with a width of 7 mm
Anthropometric measurement (arm circumference measurement) was made with a tape measure of 7 mm width.
Measured: three weeks
The biochemical examination of CK (creatine kinase)
Creatine kinase concentration in the blood was evaluated.
Measured: three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start12 May 2018
- Primary completion12 May 2019
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Burn InjuryStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engin Ramazanoglu, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04417439
- Sponsor's protocol ID
- ERamazanoglu
- Status last verified
- Jun 2020
- First submitted
- 31 May 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Flores O, Tyack Z, Stockton K, Ware R, Paratz JD. Exercise training for improving outcomes post-burns: a systematic review and meta-analysis. Clin Rehabil. 2018 Jun;32(6):734-746. doi: 10.1177/0269215517751586. Epub 2018 Jan 10.
PubMed 29320878Goverman J, Mathews K, Goldstein R, Holavanahalli R, Kowalske K, Esselman P, Gibran N, Suman O, Herndon D, Ryan CM, Schneider JC. Adult Contractures in Burn Injury: A Burn Model System National Database Study. J Burn Care Res. 2017 Jan/Feb;38(1):e328-e336. doi: 10.1097/BCR.0000000000000380.
PubMed 27380122
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turgut Özal Medical Center
- ClinicalTrials.gov ID
- NCT04417439
- Acronym / sponsor ID
- ERamazanoglu
- Conditions
- Burn Injury
- Keywords
- Acute-phase burn, Creatine Kinase, MM Form,, Musculoskeletal Development, Treatment Effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 12 May 2018 (actual)
- Primary completion
- 12 May 2019 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 4 Jun 2020 (actual)
- 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.
There are very few studies indicating the effect of acute phase treatment approaches on creatine kinase and the musculoskeletal system in the physiotherapy and rehabilitation process. Rehabilitation in burn patients is a benchmark due to return to pre-burn life. Therefore, this study was conducted to determine the effect of acute phase treatment approaches on creatine kinase and the musculoskeletal system in different types of burns.
Detailed description
In the literature, there are very few objective and quantitative studies comparing the effects of standard wound care and rehabilitation period on different burn types in burn patients. Thus, our study was designed to investigate the effects of acute phase treatment approaches on creatine kinase and the musculoskeletal system in different types of burns.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| flame burns | – | Other: universal goniometer. evaluate the circumference measurement. The biochemical examination of CK (creatine kinase)The joint range of motion was assessed by a universal goniometer within the affected areas of burn patients. A tape measure with a width of 7 mm was used to evaluate the circumference measurement in individuals. The biochemical examination of CK (creatine kinase) was performed in the laboratories. |
| scald burns | – | Other: universal goniometer. evaluate the circumference measurement. The biochemical examination of CK (creatine kinase)The joint range of motion was assessed by a universal goniometer within the affected areas of burn patients. A tape measure with a width of 7 mm was used to evaluate the circumference measurement in individuals. The biochemical examination of CK (creatine kinase) was performed in the laboratories. |
| electrical burns | – | Other: universal goniometer. evaluate the circumference measurement. The biochemical examination of CK (creatine kinase)The joint range of motion was assessed by a universal goniometer within the affected areas of burn patients. A tape measure with a width of 7 mm was used to evaluate the circumference measurement in individuals. The biochemical examination of CK (creatine kinase) was performed in the laboratories. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 37 individuals, including 10 females and 27 males
Key inclusion criteria (2 listed)
- the study were being aged between 18-65 years and having different burn types, and flame, scald, and electrical burns were included in the study.
- The burn percentage and mortality percentage were calculated, and patients with a burn percentage of less than fifty percent were included.
Key exclusion criteria (1 listed)
- the study were having a systemic disease, having substance abuse, and having a burn percentage of more than fifty percent.
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 |
|---|---|---|
| universal goniometer. evaluate the circumference measurement. The biochemical examination of CK (creatine kinase)The joint range of motion within the affected areas of burn patients was assessed by a universal goniometer. A 7-mm-wide tape measure was used to evaluate circumference measurement in individuals. The biochemical analysis of CK (creatine kinase) was performed by an expert on blood samples taken from patients in the hospital laboratories. | Other | electrical burns, flame burns, scald burns |
Primary outcome
universal goniometer
Time frame: three weeks
Universal goniometer was used to measure arm flexion movement.
A tape measure with a width of 7 mm
Time frame: three weeks
Anthropometric measurement (arm circumference measurement) was made with a tape measure of 7 mm width.
The biochemical examination of CK (creatine kinase)
Time frame: three weeks
Creatine kinase concentration in the blood was evaluated.
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 9 Jun 2020.
- Background: PubMed 29320878Flores O, Tyack Z, Stockton K, Ware R, Paratz JD. Exercise training for improving outcomes post-burns: a systematic review and meta-analysis. Clin Rehabil. 2018 Jun;32(6):734-746. doi: 10.1177/0269215517751586. Epub 2018 Jan 10.
- Background: PubMed 27380122Goverman J, Mathews K, Goldstein R, Holavanahalli R, Kowalske K, Esselman P, Gibran N, Suman O, Herndon D, Ryan CM, Schneider JC. Adult Contractures in Burn Injury: A Burn Model System National Database Study. J Burn Care Res. 2017 Jan/Feb;38(1):e328-e336. doi: 10.1097/BCR.0000000000000380.
- Individual participant dataSharing planned: Undecided
Related trials for Burn Injury
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burn Injury, run by Inonu University at 2 sites in Turkey (Türkiye).
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 1 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 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
universal goniometer (time frame: three weeks). The study lists 3 primary outcomes in all. 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 NCT04417439, which also lists 2 linked publications.
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 9 Jun 2020.