Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202009682240691 Date of Approval: 16/09/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Efficacy of Shockwave-Enhanced Contractubex Gel on Burn Scars
Official scientific title Efficacy of Shockwave-Enhanced Contractubex Gel on Burn Scars: A single-blinded, Parallel groups, Randomized Controlled Trial
Brief summary describing the background and objectives of the trial The mechanism of the shock wave in introducing drugs through the skin is not yet clear. But shockwave-related cavitation may be the key as some researchers stated. Although there are several modalities for burn scar treatment, they are not always satisfactory, also there are a few studies which investigated the effects of shockwave therapy on improving scar appearance, besides, no or limited studies had been used shockwave therapy as a modality for transdermal drug delivery. All these factors enforced the researcher to design this study to evaluate shockwave therapy efficacy on post-burn scars as well as its ability to enhance and magnify contractubex gel effect on burn scars
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Burn
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 06/09/2020
Actual trial start date
Anticipated date of last follow up 06/12/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Study group 1 twice a week 8 weeks In group A, the defined scar areas were treated with an area-dependent quantity of contractubex gel (A commercial contractubex gel, includes cepea extract, heparin sodium, and allantoin contents, Merz Pharma, Frankfurt, Germany) under a fitted occlusive dressing for 30 minutes to enhance scar tissues saturation with gel, during that period, shock wave therapy (Duolith T-Top product, Company of Storz Medical, Tägerwilen, Made in Switzerland) with the following parameters; 100 impulses/cm2, 0.1 mJ / mm2 energy, frequency of 4Hz .was applied over all occlusive dressing area as the sonic gel was used as a coupling medium. 15
Experimental Group Study Group 2 Twice a week 8 weeks In group B, firstly, the defined scar area under fitted occlusive dressing received the ESWT application with the sonic gel as a coupling medium using the same parameter as in group A then occlusive dressing was removed and the area was cleaned with a wet wipe for immediately receiving an area-dependent quantity of contractubex gel under a new fitted occlusive dressing for 30 minutes. 15
Control Group Control group Twice a week 8 weeks In group C (control group); All patients received only an area-dependent quantity of contractubex gel under a fitted occlusive dressing for 30 minutes. 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Ages were between 20 and 50 years old patients had hypertrophic scars for 3–12 months after a second or third-degree thermal burn at the upper limb, lower limb, or trunk. Patients had electrical or chemical burns. keloid, open wound. Peripheral vascular diseases, previous scars in the treated area. Skin disease, diabetes, arrhythmias, pacemaker implantation. Tumors, being pregnant. Patients had any other treatments for scar area (in the tested region) under investigation. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 50 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/07/2020 Faculty Of Physical Therapy Ethical Committee
Ethics Committee Address
Street address City Postal code Country
7th Ahmed Elzayat St., Been Elsarayate, Dokki. Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Each scar characteristic was assessed with a Modified Vancouver Scar Scale and separately scored with 0 scores as referred to normal skin and higher scores as referred to greater pathology. These characteristics include; Pigmentation {scores: normal (0), hypopigmentation (1), mixed pigmentation (2) and hyperpigmentation (3)},Vascularity {scores: normal (0), pink (1), red (2), and purple (3) }, Pliability {scores: normal (0), supple (1), yielding (2), firm (3) banding (4) and contracture (5) }, and Height {scores: normal or flat (0), 0-1mm (1), 1-2mm (2), 2-4mm(3), and >4mm(4) } The summation of characteristics scores is commonly used to assess the overall severity of the scars Baseline, after 4 weeks, and after 8weeks of intervention
Secondary Outcome The patient’s pain and itching from the scar were evaluated by a visual analog scale (VAS) as each patient determined the level of his/her pain and itching by a number located between 0 and 10. Zero refers to very low pain and itching, whereas 10 refers to severe pain and itching. Baseline, after 4 weeks, and after 8weeks of intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of physical Therapy 7th Ahmed Elzayat street Giza 11432 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Nabil Mahmoud Abdel Aal 7 Ahmed Elzayat Giza 11432 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical Therapy Cairo University 7th Ahmed Elzayat st. Giza 11432 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr.Hesham Galal Mahran 7th Ahmed Giza 11432 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nabil Abdel Aal nabil.mahmoud@cu.edu.eg +201200133613 7th Ahmed Elzayat st., Been Elsarayate, Dokki
City Postal code Country Position/Affiliation
Giza 11432 Egypt Lecturer of Physical Therapy Basic Science Department
Role Name Email Phone Street address
Scientific Enquiries Hesham Mahran heshammahran75@yahoo.com +201094198949 7 Th Ahmed Elzayat st.
City Postal code Country Position/Affiliation
Giza 11432 Egypt Assistant Professor
Role Name Email Phone Street address
Public Enquiries Nabil Abdel Aal nabil.mahmoud@cu.edu.eg +201200133613 7th Ahmed El zayate st
City Postal code Country Position/Affiliation
Giza 11432 Egypt Lecturer of physical Therapy
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will share the results of this study within 6 months of the study completion regarding Vancouver scale, pain intensity, and itching pain. Clinical Study Report 6 month after the study completion The criteria will be accessed by the publication of the trial in an international journal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information