Burns LaserNCT06198283
Effects of Pressure Garments on Hypertrophic Hand Scar in Burn Children
A study testing Low Level LASER Therapy with Pressure Garment and Low Level LASER Therapy without Pressure Garment in people with Burns Laser, run by Riphah International University at 1 site in Pakistan.
Trial summary
Burns are type of injury that affect the skin or other tissues and are typically caused by acute trauma, including thermal sources, electricity, chemicals, friction, or radiation. Thermal burns are frequently caused by exposure to high temperature solids or liquids, as well as flames. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Burns Laser
- What is being tested?
- Low Level LASER Therapy with Pressure Garment and Low Level LASER Therapy without Pressure Garment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Nov 2023to 15 Jan 2024
- 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 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 2-10 years
- Patient with 2nd degree of burns on hands and develop scar
- Patients after 3 months of burn on hand
- Only patients that were diagnosed with hypertrophic scars secondary to burn injuries were included
- Patients those with second degree burns or more or those with HS from burns
- Scar type (hypertrophic, flat or atrophic) and scar dyschromia (i.e. erythema) are the main factors that drive laser device selection
Who cannot join
- Participants who have certain medical problems that may impair scar healing or response to therapy interventions (such as uncontrolled diabetes, autoimmune disorders, or immunocompromised states).
- Those who have suffered burns recently (within the past few weeks) or who have had their scars for a long time (five years or more)
- Wounds that have open area and risk of bleeding occurs.
- Any spinal cord injuries.
- Patients with any other skin disease like skin cancer, inflammation,Allergic conditions etc
- Patients with under treatment like radiations etc
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah International University
Lahore, Punjab Province, 54000
About this study
Official title: Effects of Pressure Garments With and Without Low Level Laser Therapy on Hypertrophic Hand Scar in Children With Burn
Burns are type of injury that affect the skin or other tissues and are typically caused by acute trauma, including thermal sources, electricity, chemicals, friction, or radiation. Thermal burns are frequently caused by exposure to high temperature solids or liquids, as well as flames. The epidermis is the only layer of skin affected by superficial burns (sometimes known as "first degree" burns). Blistering is a common symptom of partial thickness (second degree) burns, which damage both the epidermis and dermis.
Read the detailed description
This study will include patients with age 2-10 \& having burns on hands and develop scars will be recruited through Randomized Controlled trial in which convenience sampling technique will be used. Two groups will be formed in which participants will be divided by lottery method. Group A which will be treated by low level laser therapy with pressure garment (8-10hrs a day) and group B which will receive low level LASER therapy (422-800nm) without pressure garment only for the duration of 6 weeks (3 days in a week with 20-30 minutes per session). Vancouver Scar Scale and PSOAS tool will be used. The result after statistical analysis will either show both treatments equally effective or not. Data will be calculated before and after treatment with the help of outcome measure tools. Results will be analyzed on SPSS.
- Conditions
- Burns Laser
- Being tested
- Low Level LASER Therapy with Pressure Garment, Low Level LASER Therapy without Pressure Garment
- Keywords
- Burn scar, Hypertrophy Scar, Pressure garment,, Low level laser,
- Medical subject headings
- Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level LASER Therapy with Pressure GarmentOther
This group will be treated by low level laser therapy with pressure garment (8-10hrs a day) by Laplace' s Law method because it is more accurate since the range of pressures that can be delivered to a particular range of body circumferences varies depending on the fabric used and its particular tension- extension profile, the method is difficult to utilize manually and till present there is no available design tool to aid in its application. Pressure garments generate an increase in subdermal pressures in the range 9- 90 mmHg depending on the anatomical site. Garments over soft tissues generate pressures ranging from 9 to 33 mmHg. Over bony prominences the pressures range from 47 to 90 mmHg. 25mmHg pressure will be provided by garments and garments will be replaced in every 2 months
Low Level LASER Therapy without Pressure GarmentOther
This group will receive low level LASER therapy (422-800nm) without pressure garment only for the duration of 6 weeks (3 days in a week with 20-30 minutes per session).
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | This group will be treated by low level laser therapy with pressure garments Receives: Other: Low Level LASER Therapy with Pressure Garment |
| Group B | Active comparator | This group will receive low level LASER therapy without pressure garment Receives: Other: Low Level LASER Therapy without Pressure Garment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient and observer Scar Assessment scale (POSAS)
The patient and observer scar evaluation scale (POSAS) was developed to objectively grade different scars based on the opinions of both the patient and an observer. The ease of use and comprehensive information it delivers make this instrument preferable to others. It was applied to the assessment of burn scars and linear surgical scars, with results that were both reliable and valid.Predictive validity was considered excellent with a AUC of 0.9, good from 0.8 to 0.899, adequate from 0.7 to 0.799 and poor when <0.7. A scale is considered internally consistent with a Cronbach' s alpha from0.70 to 0.90. For ICCs a minimum value of 0.70 was considered as an acceptable reliable result.
Measured: 6 weeks
Vancouver Scar Scale VSS
The Vancouver Scar Scale (VSS), formerly called the Burn Scar Index, is the most used objective scar grading system. It was created in 1990. The VSS has a total score out of 13, broken down into four categories: pigmentation, vascularity, pliability, and scar height. The VSS isn't perfect because it doesn't take into account the patient's perspective, is subject to operator- dependent errors, leaves out discomfort and pruritis, and doesn't hold anyone responsible for huge scars with uneven coloration. Nonetheless, because of its intended use in assessing burn scars, it has become the most popular and widely-used scale of its kind.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start28 Nov 2023
- Primary completion31 Dec 2023
- Study completion15 Jan 2024
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 Burns LaserStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Hammad Subhani, MS*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198283
- Sponsor's protocol ID
- REC/RHS & AHS/23/0763
- Status last verified
- Jan 2024
- First submitted
- 26 Dec 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Noorbakhsh SI, Bonar EM, Polinski R, Amin MS. Educational Case: Burn Injury-Pathophysiology, Classification, and Treatment. Acad Pathol. 2021 Nov 28;8:23742895211057239. doi: 10.1177/23742895211057239. eCollection 2021 Jan-Dec.
PubMed 34869832Alnababtah K, Khan S, Ashford R. Socio-demographic factors and the prevalence of burns in children: an overview of the literature. Paediatr Int Child Health. 2016 Feb;36(1):45-51. doi: 10.1179/2046905514Y.0000000157. Epub 2014 Oct 13.
PubMed 25309999
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pressure Garments With and Without Low Level Laser Therapy on Hypertrophic Hand Scar in Children With Burn
- ClinicalTrials.gov ID
- NCT06198283
- Acronym / sponsor ID
- REC/RHS & AHS/23/0763
- Conditions
- Burns Laser
- Keywords
- Burn scar, Hypertrophy Scar, Pressure garment,, Low level laser,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 10 Jan 2024 (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.
Burns are type of injury that affect the skin or other tissues and are typically caused by acute trauma, including thermal sources, electricity, chemicals, friction, or radiation. Thermal burns are frequently caused by exposure to high temperature solids or liquids, as well as flames. The epidermis is the only layer of skin affected by superficial burns (sometimes known as "first degree" burns). Blistering is a common symptom of partial thickness (second degree) burns, which damage both the epidermis and dermis.
Detailed description
This study will include patients with age 2-10 \& having burns on hands and develop scars will be recruited through Randomized Controlled trial in which convenience sampling technique will be used. Two groups will be formed in which participants will be divided by lottery method. Group A which will be treated by low level laser therapy with pressure garment (8-10hrs a day) and group B which will receive low level LASER therapy (422-800nm) without pressure garment only for the duration of 6 weeks (3 days in a week with 20-30 minutes per session). Vancouver Scar Scale and PSOAS tool will be used. The result after statistical analysis will either show both treatments equally effective or not. Data will be calculated before and after treatment with the help of outcome measure tools. Results will be analyzed on SPSS.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Low Level LASER Therapy with Pressure GarmentThis group will be treated by low level laser therapy with pressure garments |
| Group B | Active comparator | Other: Low Level LASER Therapy without Pressure GarmentThis group will receive low level LASER therapy without pressure garment |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age 2-10 years
- Patient with 2nd degree of burns on hands and develop scar
- Patients after 3 months of burn on hand
- Only patients that were diagnosed with hypertrophic scars secondary to burn injuries were included
- Patients those with second degree burns or more or those with HS from burns
Key exclusion criteria (6 listed)
- Participants who have certain medical problems that may impair scar healing or response to therapy interventions (such as uncontrolled diabetes, autoimmune disorders, or immunocompromised states).
- Those who have suffered burns recently (within the past few weeks) or who have had their scars for a long time (five years or more)
- Wounds that have open area and risk of bleeding occurs.
- Any spinal cord injuries.
- Patients with any other skin disease like skin cancer, inflammation,Allergic conditions etc
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 |
|---|---|---|
| Low Level LASER Therapy with Pressure GarmentThis group will be treated by low level laser therapy with pressure garment (8-10hrs a day) by Laplace' s Law method because it is more accurate since the range of pressures that can be delivered to a particular range of body circumferences varies depending on the fabric used and its particular tension- extension profile, the method is difficult to utilize manually and till present there is no available design tool to aid in its application. Pressure garments generate an increase in subdermal pressures in the range 9- 90 mmHg depending on the anatomical site. Garments over soft tissues generate pressures ranging from 9 to 33 mmHg. Over bony prominences the pressures range from 47 to 90 mmHg. 25mmHg pressure will be provided by garments and garments will be replaced in every 2 months | Other | Group A |
| Low Level LASER Therapy without Pressure GarmentThis group will receive low level LASER therapy (422-800nm) without pressure garment only for the duration of 6 weeks (3 days in a week with 20-30 minutes per session). | Other | Group B |
Primary outcome
Patient and observer Scar Assessment scale (POSAS)
Time frame: 6 weeks
The patient and observer scar evaluation scale (POSAS) was developed to objectively grade different scars based on the opinions of both the patient and an observer. The ease of use and comprehensive information it delivers make this instrument preferable to others. It was applied to the assessment of burn scars and linear surgical scars, with results that were both reliable and valid.Predictive validity was considered excellent with a AUC of 0.9, good from 0.8 to 0.899, adequate from 0.7 to 0.799 and poor when <0.7. A scale is considered internally consistent with a Cronbach' s alpha from0.70 to 0.90. For ICCs a minimum value of 0.70 was considered as an acceptable reliable result.
Vancouver Scar Scale VSS
Time frame: 6 weeks
The Vancouver Scar Scale (VSS), formerly called the Burn Scar Index, is the most used objective scar grading system. It was created in 1990. The VSS has a total score out of 13, broken down into four categories: pigmentation, vascularity, pliability, and scar height. The VSS isn't perfect because it doesn't take into account the patient's perspective, is subject to operator- dependent errors, leaves out discomfort and pruritis, and doesn't hold anyone responsible for huge scars with uneven coloration. Nonetheless, because of its intended use in assessing burn scars, it has become the most popular and widely-used scale of its kind.
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 30 Jan 2024.
- Background: PubMed 34869832Noorbakhsh SI, Bonar EM, Polinski R, Amin MS. Educational Case: Burn Injury-Pathophysiology, Classification, and Treatment. Acad Pathol. 2021 Nov 28;8:23742895211057239. doi: 10.1177/23742895211057239. eCollection 2021 Jan-Dec.
- Background: PubMed 25309999Alnababtah K, Khan S, Ashford R. Socio-demographic factors and the prevalence of burns in children: an overview of the literature. Paediatr Int Child Health. 2016 Feb;36(1):45-51. doi: 10.1179/2046905514Y.0000000157. Epub 2014 Oct 13.
- 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.
Ali Hammad Subhani, MS* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Level LASER Therapy with Pressure Garment and Low Level LASER Therapy without Pressure Garment in people with Burns Laser, run by Riphah International University at 1 site in Pakistan.
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 6 inclusion and 6 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 30 Jan 2024. 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 Pakistan. 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?
Patient and observer Scar Assessment scale (POSAS) (time frame: 6 weeks). The study lists 2 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 NCT06198283, 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 30 Jan 2024.