NCT04532840

Effect of Cryotherpy on Hypertrophic Scar

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Zakria Mowafy · Academic / Other
• Sex: All
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hypertrophic Scars

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-04-15
• Primary completion: 2020-09-15
• Completion: 2020-10-01
• First posted: 2020-08-31
• Last updated: 2020-08-31

Locations

1 site across 1 country: Egypt