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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02708628
Enrollment
120
Registered
2016-03-15
Start date
2015-12-31
Completion date
2016-10-31
Last updated
2016-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cicatrix

Keywords

scar prevention, sectio, extract of allium cepae, allantoin, heparin

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.

Interventions

DRUGextract 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

PROCEDUREScar excision

Scar excision in second c-section

Sponsors

Suleymaniye Birth And Women's Health Education And Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime 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.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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026