The Efficacy of Extract of Allium Cepae, Allantoin and Heparin in Patients With Proven Scar Development
Primary Purpose
Cicatrix
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
extract of allium cepae, allantoin and heparin
Scar excision
Sponsored by
About this trial
This is an interventional prevention trial for Cicatrix focused on measuring scar prevention, sectio, extract of allium cepae, allantoin, heparin
Eligibility Criteria
Inclusion Criteria:
- Patients who are admitted for the second cesarean delivery
- Not to use topical scar gel after the first c-section
Exclusion Criteria:
- chronic illness, immunosuppressive therapy or smoking
- development of wound infection during the second c- section
- allergies and hypersensitivities to components of the gel
Sites / Locations
- Suleymaniye Birth And Women's Health Education And Research Hospital.
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Patients using contractubex
Patients not using contractubex
Arm Description
Scar excision will be performed in second c-section for 60 patients and these patients will use prophylactic topical scar gel containing extract of allium cepae, allantoin and heparin two times in a day.
Scar excision will be performed in second c-section for 60 patients and these patients will not use prophylactic topical scar gel containing extract of allium cepae, allantoin and heparin.
Outcomes
Primary Outcome Measures
POSAS observer score change will be assessed by POSAS observer scale (The Patient and Observer Scar Assessment Scale v2.0) just prior to second c-section and at 6,12 and 24 weeks following the c-section.
POSAS patient score change will be assessed by POSAS patient scale (The Patient and Observer Scar Assessment Scale v2.0) just prior to second c-section and at 6,12 and 24 weeks following the c-section.
Vancouver scar score change will be assessed by Vancouver scar scale just prior to second c-section and at 6,12 and 24 weeks following the c-section.
Secondary Outcome Measures
Full Information
NCT ID
NCT02708628
First Posted
February 29, 2016
Last Updated
October 2, 2016
Sponsor
Suleymaniye Birth And Women's Health Education And Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02708628
Brief Title
The Efficacy of Extract of Allium Cepae, Allantoin and Heparin in Patients With Proven Scar Development
Official Title
The Efficacy of Prophylactic Use of Extract of Allium Cepae, Allantoin and Heparin in Patients With Proven Scar Development After Excision of Previous Scar
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Suleymaniye Birth And Women's Health Education And Research Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate the efficacy of prophylactic use of a topical gel containing extract of allium cepae, allantoin and heparin after surgical removal of the primary cesarean scar in the second cesarean section.
Detailed Description
120 patients who are admitted for the second cesarean delivery, not taking prophylactic medication after the first cesarean section, whose scar development and measurements are taken will be included in the study. First caesarean section scars will be removed surgically for all patients. 60 out of 120 patients (treatment group) will use prophylactic topical scar gel 2 times in a day, and remaining 60 patients (control group )won't use. The efficacy of the drug will be evaluated by taking strict measurements of the incision and POSAS (The Patient and Observer Scar Assessment Scale) and Vancouver Scales at 6.12 and 24 weeks.
Steps;
Observation of the primary cesarean scar by taking scar measurements and using Vancouver and POSAS scales.
Surgical removal of the primary cesarean scar in the second cesarean section.
24 weeks topical application of gel containing extract of allium cepae, allantoin and heparin(only treatment group).
Observation of the skin incision at 6,12 and 24 weeks by taking scar measurements with using Vancouver and POSAS scales.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cicatrix
Keywords
scar prevention, sectio, extract of allium cepae, allantoin, heparin
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients using contractubex
Arm Type
Active Comparator
Arm Description
Scar excision will be performed in second c-section for 60 patients and these patients will use prophylactic topical scar gel containing extract of allium cepae, allantoin and heparin two times in a day.
Arm Title
Patients not using contractubex
Arm Type
Active Comparator
Arm Description
Scar excision will be performed in second c-section for 60 patients and these patients will not use prophylactic topical scar gel containing extract of allium cepae, allantoin and heparin.
Intervention Type
Drug
Intervention Name(s)
extract of allium cepae, allantoin and heparin
Other Intervention Name(s)
Contractubex
Intervention Description
prophylactic use of a topical gel containing extract of allium cepae, allantoin and heparin two times in a day after second c-section
Intervention Type
Procedure
Intervention Name(s)
Scar excision
Intervention Description
Scar excision in second c-section
Primary Outcome Measure Information:
Title
POSAS observer score change will be assessed by POSAS observer scale (The Patient and Observer Scar Assessment Scale v2.0) just prior to second c-section and at 6,12 and 24 weeks following the c-section.
Time Frame
just prior to second c-section and at 6,12,24 weeks
Title
POSAS patient score change will be assessed by POSAS patient scale (The Patient and Observer Scar Assessment Scale v2.0) just prior to second c-section and at 6,12 and 24 weeks following the c-section.
Time Frame
just prior to second c-section and at 6,12,24 weeks
Title
Vancouver scar score change will be assessed by Vancouver scar scale just prior to second c-section and at 6,12 and 24 weeks following the c-section.
Time Frame
just prior to second c-section and at 6,12,24 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients who are admitted for the second cesarean delivery
Not to use topical scar gel after the first c-section
Exclusion Criteria:
chronic illness, immunosuppressive therapy or smoking
development of wound infection during the second c- section
allergies and hypersensitivities to components of the gel
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Galip Zebitay, M.D.
Organizational Affiliation
Suleymaniye Birth And Women's Health Education And Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Suleymaniye Birth And Women's Health Education And Research Hospital.
City
Istanbul
ZIP/Postal Code
34020
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Efficacy of Extract of Allium Cepae, Allantoin and Heparin in Patients With Proven Scar Development
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