Clinical trial NCT06198283: Effects of Pressure Garments on Hypertrophic Hand Scar in Burn Children
Official title: Effects of Pressure Garments With and Without Low Level Laser Therapy on Hypertrophic Hand Scar in Children With Burn
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns Laser
Keywords: Burn scar, Hypertrophy Scar
Pressure garment,
Low level laser,
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 26
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Patient and observer Scar Assessment scale (POSAS)
timeFrame: 6 weeks
measure: Vancouver Scar Scale VSS
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Ali Hammad Subhani, MS*
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Alnababtah 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.