Clinical trial NCT04532840: Effect of Cryotherpy on Hypertrophic Scar
Official title: Effect of Cryotherpy on Hypertrophic Scar
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Hypertrophic Scars
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-08-31
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: scar height
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
References:
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.
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.