Ignite Creation Date:
2024-05-06 @ 12:29 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03777891
Status:
COMPLETED
Last Update Posted:
2018-12-17
First Post:
2018-12-14
Brief Title:
Effect of Silicone Gel Versus Contractubex Phonophoresis for Post-burn Hypertrophic Scars
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Effect of Silicone Gel Versus Contractubex Phonophoresis for Post-burn Hypertrophic Scars A Single Blind Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 05 Wcm2 and the treatment time was 5 minutes The Ultrasound Device is Sonopulse 590 Nonius sonopuls 590 SNO03-202 type 14663900 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 05 Wcm2 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 05 Wcm2 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 persons 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
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 05 Wcm2 and the treatment time was 5 minutes The Ultrasound Device is Sonopulse 590 Nonius sonopuls 590 SNO03-202 type 14663900 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 05 Wcm2 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 05 Wcm2 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 persons 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None