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Effect of Cryotherpy on Hypertrophic Scar

Effect of Cryotherpy on Hypertrophic Scar

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04532840
Enrollment
60
Registered
2020-08-31
Start date
2019-04-15
Completion date
2020-10-01
Last updated
2020-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic Scars

Brief 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.

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

Interventions

DEVICEcryotherapy (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.

OTHERExercising, Positioning and splinting, Pressure Therapy and Massage

Exercising, Positioning and splinting, Pressure Therapy and Massage

Sponsors

Zakria Mowafy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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) (Masters et al., 2006). 2.2. Therapeutic equipment: Gymna Cryoflow ICE-CT. Temperature resistant polymide tape (48 wide)

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
scar height3 monthsThe potential of cryotherapy application in vitro data indicated that using freezing treatment on scar decrease its height

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026