The Efficacy of Extract of Allium Cepae, Allantoin and Heparin in Patients With Proven Scar Development

October 2, 2016 updated by: Suleymaniye Birth And Women's Health Education And Research Hospital

The Efficacy of Prophylactic Use of Extract of Allium Cepae, Allantoin and Heparin in Patients With Proven Scar Development After Excision of Previous Scar

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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;

  1. Observation of the primary cesarean scar by taking scar measurements and using Vancouver and POSAS scales.
  2. Surgical removal of the primary cesarean scar in the second cesarean section.
  3. 24 weeks topical application of gel containing extract of allium cepae, allantoin and heparin(only treatment group).
  4. Observation of the skin incision at 6,12 and 24 weeks by taking scar measurements with using Vancouver and POSAS scales.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34020
        • Suleymaniye Birth And Women's Health Education And Research Hospital.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients using contractubex
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.
Drug: extract of allium cepae, allantoin and heparin
prophylactic use of a topical gel containing extract of allium cepae, allantoin and heparin two times in a day after second c-section
Other Names:
  • Contractubex
Procedure: Scar excision
Scar excision in second c-section
Active Comparator: Patients not using contractubex
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.
Procedure: Scar excision
Scar excision in second c-section

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
just prior to second c-section and at 6,12,24 weeks
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
just prior to second c-section and at 6,12,24 weeks
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
just prior to second c-section and at 6,12,24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Suleymaniye Birth And Women's Health Education And Research Hospital

Investigators

  • Principal Investigator: Ali Galip Zebitay, M.D., Suleymaniye Birth And Women's Health Education And Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

February 29, 2016

First Submitted That Met QC Criteria

March 9, 2016

First Posted (Estimate)

March 15, 2016

Study Record Updates

Last Update Posted (Estimate)

October 4, 2016

Last Update Submitted That Met QC Criteria

October 2, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGZ-EAC-A-H-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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