Effect of Cryotherpy on Hypertrophic Scar

NCT04532840 | Unknown Phase 2

• 1 other identifier: P.t.REC/012/002266
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Scars

Outcome Measures

Primary Outcomes (1)

• scar height

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

  3 months

Study Arms (2)

Group A: (control group)

ACTIVE COMPARATOR

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

Group B: (Study group)

EXPERIMENTAL

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.

Device: cryotherapy (Gymna Cryoflow ICE-CT); Other: Exercising, Positioning and splinting, Pressure Therapy and Massage

Interventions

cryotherapy (Gymna Cryoflow ICE-CT) DEVICE

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.

Also known as: Gymna Cryoflow ICE-CT

Group B: (Study group)

Exercising, Positioning and splinting, Pressure Therapy and Massage OTHER

Exercising, Positioning and splinting, Pressure Therapy and Massage

Group A: (control group); Group B: (Study group)

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Diabetes mellitus.
• Individuals with cardiopulmonary conditions.
• Individuals undergoing radiation therapy or chemotherapy.
• Hepatic or pancreatic diseases.
• Sensory impairment

Sponsors & Collaborators

• Zakria Mowafy: lead

Study Sites (1)

Faculty of Physical Therapy

Cairo, Egypt

Location

Related Publications (2)

• 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.

  PMID: 24767715 BACKGROUND

• 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.

  PMID: 16274932 BACKGROUND

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Interventions

Cryotherapy; Patient Positioning; Massage

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Physical Therapy for Surgery Faculty of Physical Therapy

Model Details: 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)

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 31, 2020
• Study Start: April 15, 2019
• Primary Completion: September 15, 2020
• Study Completion: October 1, 2020
• Last Updated: August 31, 2020

Record last verified: 2020-08

Locations

EG (1)