Effect of Cryotherpy on Hypertrophic Scar

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.

Study Overview

• Status: Unknown
• Conditions: Hypertrophic Scars
• Intervention / Treatment: Other: Exercising, Positioning and splinting, Pressure Therapy and Massage; Device: cryotherapy (Gymna Cryoflow ICE-CT)

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A: (control group); This group includes 30 patients will receive routine medical treatment and routine physical therapy as (Exercising, Positioning and splinting, Pressure Therapy and Massage).	Other: Exercising, Positioning and splinting, Pressure Therapy and Massage; Exercising, Positioning and splinting, Pressure Therapy and Massage
Experimental: Group B: (Study group); 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.	Other: Exercising, Positioning and splinting, Pressure Therapy and Massage; Exercising, Positioning and splinting, Pressure Therapy and Massage; 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 Names: Gymna Cryoflow ICE-CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
scar height	The potential of cryotherapy application in vitro data indicated that using freezing treatment on scar decrease its height	3 months

Collaborators and Investigators

• Sponsor: Zakria Mowafy

Publications and helpful links

General Publications

• 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.
• 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. doi: 10.1016/j.burns.2005.08.023. Epub 2005 Nov 4.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2019
• Primary Completion (Anticipated): September 15, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (Actual): August 31, 2020

Study Record Updates

• Last Update Posted (Actual): August 31, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Anatomical; Fibrosis; Cicatrix; Hypertrophy; Cicatrix, Hypertrophic
• Other Study ID Numbers: P.t.REC/012/002266

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No