Effects of Pressure Garments on Hypertrophic Hand Scar in Burn Children

January 28, 2024 updated by: Riphah International University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Riphah International University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
This group will be treated by low level laser therapy with pressure garments
Other: Low Level LASER Therapy with Pressure Garment
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
Active Comparator: Group B
This group will receive low level LASER therapy without pressure garment
Other: Low Level LASER Therapy without Pressure Garment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 weeks
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Ali Hammad Subhani, MS*, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

January 15, 2024

Study Registration Dates

First Submitted

December 26, 2023

First Submitted That Met QC Criteria

December 26, 2023

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 28, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RHS & AHS/23/0763

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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