Effect of Silicone Gel Versus Contractubex Phonophoresis for Post-burn Hypertrophic Scars
Condition: Hypertrophic Scar
MeSH terms: Hypertrophy; Cicatrix, Hypertrophic
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): phonophoresis with different material
Intervention type(s): Combination Product
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment