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

Hypertrophic Scar Clinical Trial

Official title:

Effect of Silicone Gel Versus Contractubex Phonophoresis for Post-burn Hypertrophic Scars: A Single Blind Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03777891
• Other study ID #: P.T.REC/012/001870
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2017
• Est. completion date: January 3, 2018

Study information

• Verified date: December 2018
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 3, 2018
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cicatrix, Hypertrophic
• Hypertrophic Scar
• Hypertrophy

Intervention

Combination Product:
• phonophoresis with different material
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.

Locations

Country	Name	City	State
Egypt	Hamada Ahmed Hamada	Cairo	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	pretreatment, after 12 weeks and after 24 weeks of the treatment