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Completed

NCT Number: NCT02708628

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Suleymaniye Birth And Women's Health Education And Research Hospital.

Istanbul, 34020, Turkey (Türkiye)

About this study

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;

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

extract of allium cepae, allantoin and heparin

Drug

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

Scar excision

Procedure

Scar excision in second c-section

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Suleymaniye Birth And Women's Health Education And Research Hospital

Other Gov

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 15, 2016
Registry last updated
Oct 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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