Effect of Cryotherpy on Hypertrophic Scar
cryotherapy (Gymna Cryoflow ICE-CT)
+ Exercising, Positioning and splinting, Pressure Therapy and Massage
Cicatrix+2
+ Fibrosis
+ Pathologic Processes
Treatment Study
Summary
Study start date: April 15, 2019
Actual date on which the first participant was enrolled.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
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 20 to 40 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location