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Effect of Silicone Gel Versus Contractubex Phonophoresis for Post-burn Hypertrophic Scars

Primary Purpose

Hypertrophic Scar

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
phonophoresis with different material
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrophic Scar

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients had hypertrophic scars after 2 to 4 months post thermal burn (direct flame or scald) all patients injury was deep second-degree burn and their age ranged from 20-45 years

Exclusion Criteria:

  • skin disease, diabetes, mental disorders, peripheral vascular diseases, acute viral diseases, open wound, electrical and chemical burns were excluded

Sites / Locations

  • Hamada Ahmed Hamada

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

group A

group B

group C

Arm Description

received Silicone gel phonophoresis: Silicone gel (strataderm) was applied to the scar then the ultrasound was implemented by the therapist. The ultrasound parameters were set as following, frequency: 1 MHz, intensity: 0.5 W/cm2 and the treatment time was 5 minutes. The Ultrasound Device is Sonopulse 590: Nonius, sonopuls 590, S.NO.03-202 type 14663.900 was a therapeutic ultrasound device manufactured by Enraf Holland.

received Contractubex phonophoresis: Contractubex (Merz Pharma, Frankfurt, Germany was applied to the scar then the ultrasound was implemented by the therapist. The ultrasound parameters were set as following, frequency: 1 MHz, intensity: 0.5 W/cm2 and the treatment time was 5 minutes.

received Corticosteroid phonophoresis: A thin film of coupling medium (gel) was put on the hypertrophic scar and sufficient quantity of Triamcinolone was put by a syringe over the whole scar then the ultrasound was implemented by the therapist. The ultrasound parameters were set as following, frequency: 1 MHz, intensity: 0.5 W/cm2 and the treatment time was 5 minutes

Outcomes

Primary Outcome Measures

change of modified Vancouver scar scale
Scar assessment was done using the modified Vancouver scar scale (Danielsen et al., 2013). The modified scale is a numerical assessment of four skin characteristics, where 0 represents the person's normal skin. The characteristics include height (range 0-3), pliability (range 0-5), vascularity (range 0-3), and pigmentation (range 0-3). The assessment was done before treatment, after three months (12 weeks) (post 1) and after six months (24 weeks) of the treatment (post 2). The final outcome was measured after six months of follow-up, in terms of complete and incomplete recovery.

Secondary Outcome Measures

Full Information

First Posted
December 14, 2018
Last Updated
December 14, 2018
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT03777891
Brief Title
Effect of Silicone Gel Versus Contractubex Phonophoresis for Post-burn Hypertrophic Scars
Official Title
Effect of Silicone Gel Versus Contractubex Phonophoresis for Post-burn Hypertrophic Scars: A Single Blind Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
June 1, 2017 (Actual)
Study Completion Date
January 3, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

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
Hypertrophic scars and keloids are physically and mentally disturbed, and in addition, can cause pain and itching. Various treatment is utilized to diminish or counteract scarring. The purpose of this study was conducted to compare the effect of Silicone gel, Contractubex gel and Corticosteroid Phonophoresis for Post-burn Hypertrophic Scars. Forty-five patients with hypertrophic scars after 2 to 4 months post thermal burn, their age groups ranged from 20-45 years. Patients were randomly assigned to three groups; Group A: 15 patients (8 males and 7 females) received phonophoresis with Silicone gel, Group B: 15 patients (8 males and 7 females) received phonophoresis with Contractubex gel and Group C: 15 patients (9 males and 6 females) received Corticosteroid phonophoresis. All treatment interventions were applied at a frequency of 3sessions /week for 24 weeks. Outcome measures were performed through modified Vancouver scar scale. The assessment was done pretreatment, after 12 weeks and after 24 weeks of the treatment.
Detailed Description
Participants A convenient sample of forty-five patients, 25 male and 20 female, were recruited from the Outpatient Clinic Kasr El-Ani hospital to be treated in the Outpatient Clinic, Faculty of Physical Therapy, Cairo University. They were enrolled and assessed for their eligibility to participate in the study. To be included in the study, patients had hypertrophic scars after 2 to 4 months post thermal burn (direct flame or scald) all patients injury was deep second-degree burn and their age ranged from 20-45 years, they had been free from any other illness that may affect or impact the results as; skin disease, diabetes, mental disorders, peripheral vascular diseases, acute viral diseases, open wound, electrical and chemical burns were excluded. Randomization Informed consent was obtained from each participant after explaining the nature, purpose, and benefits of the study, informing them of their right to refuse or withdraw at any time, and about the confidentiality of any obtained information. Anonymity was assured through coding of all data. Participants with hypertrophic scar post burn were randomly assigned into three groups (group A, group B and group C) by a blinded and an independent research assistant who opened sealed envelopes that contained a computer-generated randomization card. No subjects dropped out of the study after randomization. Interventions Participants were randomly assigned into group A (GA) received Silicone gel phonophoresis: Silicone gel (strataderm) was applied to the scar then the ultrasound was implemented by the therapist. The ultrasound parameters were set as following, frequency: 1 MHz, intensity: 0.5 W/cm2 and the treatment time was 5 minutes. The Ultrasound Device is Sonopulse 590: Nonius, sonopuls 590, S.NO.03-202 type 14663.900 was a therapeutic ultrasound device manufactured by Enraf Holland. Group B (GB) received Contractubex phonophoresis: Contractubex (Merz Pharma, Frankfurt, Germany was applied to the scar then the ultrasound was implemented by the therapist. The ultrasound parameters were set as following, frequency: 1 MHz, intensity: 0.5 W/cm2 and the treatment time was 5 minutes. Group C (GC) received Corticosteroid phonophoresis: A thin film of coupling medium (gel) was put on the hypertrophic scar and sufficient quantity of Triamcinolone was put by a syringe over the whole scar then the ultrasound was implemented by the therapist. The ultrasound parameters were set as following, frequency: 1 MHz, intensity: 0.5 W/cm2 and the treatment time was 5 minutes. All groups received 72 sessions of treatment, three times per week for 24 weeks. Outcome measures Scar assessment was done using the modified Vancouver scar scale (Danielsen et al., 2013). The modified scale is a numerical assessment of four skin characteristics, where 0 represents the person's normal skin. The characteristics include height (range 0-3), pliability (range 0-5), vascularity (range 0-3), and pigmentation (range 0-3). The assessment was done before treatment, after three months (12 weeks) (post 1) and after six months (24 weeks) of the treatment (post 2). The final outcome was measured after six months of follow-up, in terms of complete and incomplete recovery.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Experimental
Arm Description
received Silicone gel phonophoresis: Silicone gel (strataderm) was applied to the scar then the ultrasound was implemented by the therapist. The ultrasound parameters were set as following, frequency: 1 MHz, intensity: 0.5 W/cm2 and the treatment time was 5 minutes. The Ultrasound Device is Sonopulse 590: Nonius, sonopuls 590, S.NO.03-202 type 14663.900 was a therapeutic ultrasound device manufactured by Enraf Holland.
Arm Title
group B
Arm Type
Experimental
Arm Description
received Contractubex phonophoresis: Contractubex (Merz Pharma, Frankfurt, Germany was applied to the scar then the ultrasound was implemented by the therapist. The ultrasound parameters were set as following, frequency: 1 MHz, intensity: 0.5 W/cm2 and the treatment time was 5 minutes.
Arm Title
group C
Arm Type
Experimental
Arm Description
received Corticosteroid phonophoresis: A thin film of coupling medium (gel) was put on the hypertrophic scar and sufficient quantity of Triamcinolone was put by a syringe over the whole scar then the ultrasound was implemented by the therapist. The ultrasound parameters were set as following, frequency: 1 MHz, intensity: 0.5 W/cm2 and the treatment time was 5 minutes
Intervention Type
Combination Product
Intervention Name(s)
phonophoresis with different material
Intervention Description
phonophoresis with Silicone gel for group A, , Group B: 15 patients (8 males and 7 females) received phonophoresis with Contractubex gel and Group C: 15 patients (9 males and 6 females) received Corticosteroid phonophoresis.
Primary Outcome Measure Information:
Title
change of modified Vancouver scar scale
Description
Scar assessment was done using the modified Vancouver scar scale (Danielsen et al., 2013). The modified scale is a numerical assessment of four skin characteristics, where 0 represents the person's normal skin. The characteristics include height (range 0-3), pliability (range 0-5), vascularity (range 0-3), and pigmentation (range 0-3). The assessment was done before treatment, after three months (12 weeks) (post 1) and after six months (24 weeks) of the treatment (post 2). The final outcome was measured after six months of follow-up, in terms of complete and incomplete recovery.
Time Frame
pretreatment, after 12 weeks and after 24 weeks of the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients had hypertrophic scars after 2 to 4 months post thermal burn (direct flame or scald) all patients injury was deep second-degree burn and their age ranged from 20-45 years Exclusion Criteria: skin disease, diabetes, mental disorders, peripheral vascular diseases, acute viral diseases, open wound, electrical and chemical burns were excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hamada A Hamada
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamada Ahmed Hamada
City
Cairo
State/Province
Giza
ZIP/Postal Code
12625
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Silicone Gel Versus Contractubex Phonophoresis for Post-burn Hypertrophic Scars

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