Effect of Cryotherpy on Hypertrophic Scar

Hypertrophic Scars Clinical Trial

Official title:

Effect of Cryotherpy on Hypertrophic Scar

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04532840
• Other study ID #: P.t.REC/012/002266
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: April 15, 2019
• Est. completion date: October 1, 2020

Study information

• Verified date: August 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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:

1. Subjects:

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

2. 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: October 1, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cicatrix, Hypertrophic
• Hypertrophic Scars
• Hypertrophy

Intervention

Device:
• cryotherapy (Gymna Cryoflow ICE-CT)
Cryotherapy (also called cryoablation) method was produced by James Arnot in England in 1945 to reduce the size of cancerous cells based on the theory that cold blood cells destroy the cells. Campbell White of New York City used cryotherapy as the first dermatological indication in early-stage epithelioma patients in 1890. Later in 1907, Whitehouse described the use of this method in diferent diseases such as pigmented nevus and lupus. In addition, he has published a case series of skin cancers in different face regions.

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

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Zakria Mowafy

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Arno AI, Gauglitz GG, Barret JP, Jeschke MG. Up-to-date approach to manage keloids and hypertrophic scars: a useful guide. Burns. 2014 Nov;40(7):1255-66. doi: 10.1016/j.burns.2014.02.011. Epub 2014 Apr 24. Review. — View Citation

Atiyeh BS, Hayek SN, Gunn SW. New technologies for burn wound closure and healing--review of the literature. Burns. 2005 Dec;31(8):944-56. Epub 2005 Nov 4. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	scar height	The potential of cryotherapy application in vitro data indicated that using freezing treatment on scar decrease its height	3 months