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Normal Saline Versus Betadine Use to Reduce the Incidence of Wound Infection in Cesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03725748
Recruitment Status : Unknown
Verified October 2018 by hadeer meshal, Kasr El Aini Hospital.
Recruitment status was:  Not yet recruiting
First Posted : October 31, 2018
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
hadeer meshal, Kasr El Aini Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Incidence of cs Scar Infection Other: irrigation Phase 2

Detailed Description:

This study will be conducted at the Department of Obstetrics & Gynecology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University, from February to July 2018.

We include in our study 3oo pregnant women who will undergo Cesarean section. All participants will be divided into 3 groups with a 1:1:1 ratio with 100 patients in each group. Each participant will provide an informed written consent.

Consenting patients will be pre-operatively randomised using numerically ordered cards in sealed envelopes to either the group 1 (wound irrigation with 100 ml of normal saline before skin closure) or the group 2 (wound irrigation with 50 ml of 10% aqueous povidone iodine solution ̋ Betadinȅ ) or the control group (no wound irrigation with normal saline nor betadine).Subjects candidate for the study will be 37 weeks' gestation and require a cesarean section (elective or emergency). Patients with allergy to iodine, history of immunosuppressive drug use, gestationaldiabetes mellitus or preeclampsia, anemic patients, ruptured of membranes and feverish patients will be excluded from the study.

The primary outcome will be the incidence of wound infection. Wound infection is diagnosed when the wound drained purulent material or serosanguineous fluid in association with induration, warmth and tenderness. Suspected wound infections are opened for confirmation and wound cultures will be taken. Haematoma, seroma, or wound breakdown in the absence of the previouslydiscussed signs is not considered a wound infection.Wounds are examined twice daily during hospitalization for evidence of infection. After discharge, the women are instructed on the signs and symptoms of wound infection, and asked to contact one of the co-authors immediately if any of the listed symptoms appeared. All participants are examined at 2 and 6 weeks after surgery.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Normal Saline Versus Betadine Use to Reduce the Incidence of Wound Infection in Cesarean
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: no irrigation group
nothing used for irrigation of cs scar
Placebo Comparator: saline irrigation group
saline used for irrigation the cs scar before closure
 Other: irrigation
irrigation the edges of the cs scar before closure
Experimental: betadine irrigation group
betadine used for irrigation of cs scar
 Other: irrigation
irrigation the edges of the cs scar before closure


Outcome Measures
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Primary Outcome Measures :
  1. incidence of cs scar infection [ Time Frame: 2 to 6 weeks ]
    incidence of cs scar infection


Secondary Outcome Measures :
  1. incidence of hematoma, seroma [ Time Frame: 2 to 6 weeks ]
    incidence of hematoma, seroma, wound breakdown


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 37 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with allergy to iodine
  • history of immunosuppressive drug use,
  • gestationaldiabetes mellitus
  • preeclampsia
  • anemic patients
  • ruptured of membranes
  • feverish patients
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03725748


Contacts
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Contact: hany saad, assistant prof 01001817211 dr_hanysaad@yahoo.co.uk
Contact: ashraf saad, lecturer 01001817221 ashraf@yahoo.co.uk

Locations
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Egypt
Kasr El Ainy
Cairo, Egypt, 02
Contact: mohamed saad, lecturer    01244336666    msaad@scimitar.com   
Sponsors and Collaborators
Kasr El Aini Hospital
Investigators
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Study Director: fady salah, lecturer Director
More Information
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Responsible Party: hadeer meshal, assistant prfessor, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT03725748    
Other Study ID Numbers: assistant professor2
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by hadeer meshal, Kasr El Aini Hospital:
saline, betadine, cesarean scar infection
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Wound Infection
Disease Attributes
Pathologic Processes