Effect of Cryotherpy on Hypertrophic Scar

Zakria Mowafy

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Hypertrophic Scars

Treatments: Other: Exercising, Positioning and splinting, Pressure Therapy and Massage; Device: cryotherapy (Gymna Cryoflow ICE-CT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04532840

P.t.REC/012/002266

Details and patient eligibility

About

Purpose of the study:

The purpose of the study is to evaluate the therapeutic effect of cryotherpy in treating hypertrophic scar.

It will be hypothesized that:

Cryotherapy may not have an effect on hypertrophic scar.

Full description

The potential of cryotherapy application in vitro data indicated that using freezing treatment on VFFs + TGF-β1 (myofibroblast) modulated ECM turnover toward antifibrosis and normalization, attenuated myofibroblast differentiation, reduced cell migration, and weakened the contractile activity. On both VFFs ± TGF-β1, freezing treatment raised LP regeneration (HAS1, decorin).

The findings indicate that cryotherapy may play a protective role in scar formation and contribute to lamina regeneration.

Furthermore the need of this study was developed from the lack in the quantitative knowledge and information in the published studies about the effect of cryotherapy on hypertrophic scar.

This study will be designed to provide a guideline about the effect of effect of cryotherapy on hypertrophic scar height, thickness and discoloration, and to assist in planning an ideal treatment regimen for reducing hypertrophic scar.

Delimitations:

This study will be delimited in the following aspects:

Subjects:

Sixty patients suffering from hypertrophic scar will be randomly divided into two equal groups each one has 30 patients.

Equipment and tools:

2.1. Measurement equipment: Vancouver scar scale. MAPS (Matching Assessment of Scars and Photographs). 2.2. Therapeutic equipment: Gymna Cryoflow ICE-CT. Temperature resistant polymide tape (48 wide).

Hypothesis:

It will be hypothesized that:

Cryotherapy may not have an effect on hypertrophic scar.

Basic Assumptions:

It will be assumed that:

All patients will receive the same kinds of medication and the same nursing care. All subjects are free from any chronic disease. All subjects will continue in the study. All patients will follow the instructions during the treatment

Enrollment: 60 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age range between 20- 40 years.
• Both sexes will participate in the study.
• All patients participated will begin treatment program one month after injury depending on injury characteristics.
• All patients enrolled to the study will have their informed consent.

Exclusion criteria

• Diabetes mellitus.
• Individuals with cardiopulmonary conditions.
• Individuals undergoing radiation therapy or chemotherapy.
• Hepatic or pancreatic diseases.
• Sensory impairment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Group A: (control group)

Active Comparator group

Description:

This group includes 30 patients will receive routine medical treatment and routine physical therapy as (Exercising, Positioning and splinting, Pressure Therapy and Massage).

Treatment:

Other: Exercising, Positioning and splinting, Pressure Therapy and Massage

Group B: (Study group)

Experimental group

Description:

This group includes 30 patients will receive cryotherapy (at least 10 minutes at -14 degree , 2 sessions per week , for 10 weeks ) in addition to routine medical and physical therapy treatment.

Treatment:

Device: cryotherapy (Gymna Cryoflow ICE-CT)

Other: Exercising, Positioning and splinting, Pressure Therapy and Massage