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Effect of Cryotherpy on Hypertrophic Scar

Primary Purpose

Hypertrophic Scars

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
cryotherapy (Gymna Cryoflow ICE-CT)
Exercising, Positioning and splinting, Pressure Therapy and Massage
Sponsored by
Zakria Mowafy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrophic Scars

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A: (control group)

Group B: (Study group)

Arm Description

This group includes 30 patients will receive routine medical treatment and routine physical therapy as (Exercising, Positioning and splinting, Pressure Therapy and Massage).

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.

Outcomes

Primary Outcome Measures

scar height
The potential of cryotherapy application in vitro data indicated that using freezing treatment on scar decrease its height

Secondary Outcome Measures

Full Information

First Posted
August 18, 2020
Last Updated
August 26, 2020
Sponsor
Zakria Mowafy
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1. Study Identification

Unique Protocol Identification Number
NCT04532840
Brief Title
Effect of Cryotherpy on Hypertrophic Scar
Official Title
Effect of Cryotherpy on Hypertrophic Scar
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
September 15, 2020 (Anticipated)
Study Completion Date
October 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zakria Mowafy

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophic Scars

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This study will be delimited in the following aspects: Subjects: Sixty patients suffering from hypertrophic scar will be randomly divided into two equal groups each one has 30 patients. 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)
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A: (control group)
Arm Type
Active Comparator
Arm Description
This group includes 30 patients will receive routine medical treatment and routine physical therapy as (Exercising, Positioning and splinting, Pressure Therapy and Massage).
Arm Title
Group B: (Study group)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
cryotherapy (Gymna Cryoflow ICE-CT)
Other Intervention Name(s)
Gymna Cryoflow ICE-CT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercising, Positioning and splinting, Pressure Therapy and Massage
Intervention Description
Exercising, Positioning and splinting, Pressure Therapy and Massage
Primary Outcome Measure Information:
Title
scar height
Description
The potential of cryotherapy application in vitro data indicated that using freezing treatment on scar decrease its height
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24767715
Citation
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.
Results Reference
background
PubMed Identifier
16274932
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. doi: 10.1016/j.burns.2005.08.023. Epub 2005 Nov 4.
Results Reference
background

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Effect of Cryotherpy on Hypertrophic Scar

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