NCT03725748

Brief Summary

This is a prospective randomized controlled study to the difference between using normal saline or betadine irrigation of wound prior to skin closure in reducing the incidence of wound infection after Cesarean section.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 31, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

October 31, 2018

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

October 20, 2018

Last Update Submit

October 29, 2018

Conditions

Incidence of cs Scar Infection

Keywords

saline, betadine, cesarean scar infection

Outcome Measures

Primary Outcomes (1)

  • incidence of cs scar infection

    incidence of cs scar infection

    2 to 6 weeks

Secondary Outcomes (1)

  • incidence of hematoma, seroma

    2 to 6 weeks

Study Arms (3)

no irrigation group

NO INTERVENTION

nothing used for irrigation of cs scar

saline irrigation group

PLACEBO COMPARATOR

saline used for irrigation the cs scar before closure

Other: irrigation

betadine irrigation group

EXPERIMENTAL

betadine used for irrigation of cs scar

Other: irrigation

Interventions

irrigationOTHER

irrigation the edges of the cs scar before closure

betadine irrigation groupsaline irrigation group

Eligibility Criteria

Age19 Years - 37 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects candidate for the study will be 37 weeks' gestation
  • require a cesarean section (elective or emergency).

You may not qualify if:

  • Patients with allergy to iodine
  • history of immunosuppressive drug use,
  • gestationaldiabetes mellitus
  • preeclampsia
  • anemic patients
  • ruptured of membranes
  • feverish patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr El Ainy

Cairo, 02, Egypt

Location

MeSH Terms

Interventions

Therapeutic Irrigation

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitationInvestigative Techniques

Study Officials

  • fady salah, lecturer

    Director

    STUDY DIRECTOR

Central Study Contacts

hany saad, assistant prof

CONTACT

01001817211dr_hanysaad@yahoo.co.uk

ashraf saad, lecturer

CONTACT

01001817221ashraf@yahoo.co.uk

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant prfessor

Study Record Dates

First Submitted

October 20, 2018

First Posted

October 31, 2018

Study Start

November 1, 2018

Primary Completion

May 1, 2019

Study Completion

June 1, 2019

Last Updated

October 31, 2018

Record last verified: 2018-10

Locations

EG(1)