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

NCT03777891 | Completed Phase 4

• 1 other identifier: P.T.REC/012/001870
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Scar

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

group A

EXPERIMENTAL

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.

Combination Product: phonophoresis with different material

group B

EXPERIMENTAL

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.

Combination Product: phonophoresis with different material

group C

EXPERIMENTAL

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

Combination Product: phonophoresis with different material

Interventions

phonophoresis with different material COMBINATION_PRODUCT

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.

group A; group B; group C

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Hamada Ahmed Hamada

Cairo, Giza Governorate, 12625, Egypt

Location

Related Publications (1)

• Sinha S, Gabriel VA, Arora RK, Shin W, Scott J, Bharadia SK, Verly M, Rahmani WM, Nickerson DA, Fraulin FO, Chatterjee P, Ahuja RB, Biernaskie JA. Interventions for postburn pruritus. Cochrane Database Syst Rev. 2024 Jun 5;6(6):CD013468. doi: 10.1002/14651858.CD013468.pub2.

  PMID: 38837237 DERIVED

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Interventions

Phonophoresis

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Hamada A Hamada

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Quality Assurance Unit

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 17, 2018
• Study Start: June 1, 2017
• Primary Completion: June 1, 2017
• Study Completion: January 3, 2018
• Last Updated: December 17, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)