Clinical trial NCT03777891: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertrophic Scar
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: change of modified Vancouver scar scale
timeFrame: pretreatment, after 12 weeks and after 24 weeks of the treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Hamada Ahmed Hamada
state: Giza
Study officials:
affiliation: Cairo University
name: Hamada A Hamada
role: PRINCIPAL_INVESTIGATOR
References: