NCT02708628

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 29, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 15, 2016

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 4, 2016

Status Verified

March 1, 2016

Enrollment Period

4 months

First QC Date

February 29, 2016

Last Update Submit

October 2, 2016

Conditions

Cicatrix

Keywords

scar preventionsectioextract of allium cepaeallantoinheparin

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Patients using contractubex

ACTIVE COMPARATOR

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.

Drug: extract of allium cepae, allantoin and heparinProcedure: Scar excision

Patients not using contractubex

ACTIVE COMPARATOR

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.

Procedure: Scar excision

Interventions

extract of allium cepae, allantoin and heparinDRUG

prophylactic use of a topical gel containing extract of allium cepae, allantoin and heparin two times in a day after second c-section

Also known as: Contractubex
Patients using contractubex
Scar excisionPROCEDURE

Scar excision in second c-section

Patients not using contractubexPatients using contractubex

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients who are admitted for the second cesarean delivery
  • Not to use topical scar gel after the first c-section

You may not qualify if:

  • chronic illness, immunosuppressive therapy or smoking
  • development of wound infection during the second c- section
  • allergies and hypersensitivities to components of the gel

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Istanbul, 34020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cicatrix

Interventions

AllantoinHeparinallantoin, heparin, onion extract drug combination

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

UreaAmidesOrganic ChemicalsHydantoinsImidazolidinesImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Ali Galip Zebitay, M.D.

    Suleymaniye Birth And Women's Health Education And Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2016

First Posted

March 15, 2016

Study Start

December 1, 2015

Primary Completion

April 1, 2016

Study Completion

October 1, 2016

Last Updated

October 4, 2016

Record last verified: 2016-03

Locations

TU(1)