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NCT Number: NCT06198283

Effects of Pressure Garments on Hypertrophic Hand Scar in Burn Children

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.

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Key information

Conditions

Burns Laser Cicatrix Cicatrix, Hypertrophic Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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).

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Pressure Garments With and Without Low Level Laser Therapy on Hypertrophic Hand Scar in Children With Burn

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jan 10, 2024
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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