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

Cicatrix Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02708628
• Other study ID #: AGZ-EAC-A-H-1
• Status: Completed
• Phase: N/A
• First received: February 29, 2016
• Last updated: October 2, 2016
• Start date: December 2015
• Est. completion date: October 2016

Study information

• Verified date: March 2016
• Source: Suleymaniye Birth And Women's Health Education And Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cicatrix

Intervention

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

Procedure:
• Scar excision
Scar excision in second c-section

Locations

Country	Name	City	State
Turkey	Suleymaniye Birth And Women's Health Education And Research Hospital.	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Suleymaniye Birth And Women's Health Education And Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No