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

Suleymaniye Birth And Women's Health Education And Research Hospital

Status: Completed

Conditions: Cicatrix

Treatments: Drug: extract of allium cepae, allantoin and heparin; Procedure: Scar excision

Study type: Interventional

Funder types: Other

Identifiers

NCT02708628

AGZ-EAC-A-H-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Patients using contractubex

Active Comparator group

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.

Treatment:

Procedure: Scar excision

Drug: extract of allium cepae, allantoin and heparin

Patients not using contractubex

Active Comparator group

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.

Treatment:

Procedure: Scar excision