Effects of Pressure Garments on Hypertrophic Hand Scar in Burn Children

NCT06198283 | Completed DMC

• 1 other identifier: REC/RHS & AHS/23/0763
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns Laser

Keywords

Burn scar, Hypertrophy Scar; Pressure garment,; Low level laser,

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  6 weeks

Study Arms (2)

Group A

EXPERIMENTAL

This group will be treated by low level laser therapy with pressure garments

Other: Low Level LASER Therapy with Pressure Garment

Group B

ACTIVE COMPARATOR

This group will receive low level LASER therapy without pressure garment

Other: Low Level LASER Therapy without Pressure Garment

Interventions

Low Level LASER Therapy with Pressure Garment OTHER

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

Group A

Low Level LASER Therapy without Pressure Garment OTHER

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).

Group B

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (2)

• 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.

  PMID: 34869832 BACKGROUND

• 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.

  PMID: 25309999 BACKGROUND

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Ali Hammad Subhani, MS*

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 10, 2024
• Study Start: November 28, 2023
• Primary Completion: December 31, 2023
• Study Completion: January 15, 2024
• Last Updated: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)