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

Not Applicable

Completed

• Conditions: Cicatrix
• Interventions: Procedure: Scar excision; Drug: extract of allium cepae, allantoin and heparin

• Registration Number: NCT02708628
• Lead Sponsor: Suleymaniye Birth And Women's Health Education And Research Hospital

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;

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 Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-02-29
• Status Verified: 2016-03
• Study First Submitted QC: 2016-03-09
• Study First Posted: 2016-03-15
• Primary Completion: 2016-04
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-02
• Last Update Posted: 2016-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients not using contractubex	Scar excision	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.
Patients using contractubex	extract of allium cepae, allantoin and heparin	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.
Patients using contractubex	Scar excision	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.

Primary Outcome Measures

Name	Time	Method
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.	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.	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.	just prior to second c-section and at 6,12,24 weeks

Trial Locations

Locations (1)

Suleymaniye Birth And Women's Health Education And Research Hospital.; 🇹🇷 Istanbul, Turkey