Swabbing of Subcutaneous Tissues of Cesarean Section Wounds With Povidone Iodine

NCT02868372 | Unknown

• 1 other identifier: AUH2
• Study Type: interventional
• Target: 538
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study has 2 groups. Group A in which the subcutaneous tissue will be swabbed with 10 cc of undiluted 10% povidone iodine and will not be mobbed. Group B ; No swabbing. Women in both groups will be followed up during hospital stay and outpatient clinic visits a week and a month after cesarean delivery for surgical site complications which will be evaluated by the researcher.

Conditions

Wound Infection

Keywords

Cesarean section; Betadine; Wound infection

Outcome Measures

Primary Outcomes (1)

• Detect and record the incidence of surgical wound infection in both groups

  : Women in both groups will be followed up during hospital stay and outpatient clinic visit for one month after cesarean delivery for surgical site complications which will be evaluated by the researcher

  One month

Study Arms (2)

Betadine group

ACTIVE COMPARATOR

Subcutaneous tissues of cesarean section wounds are swabbed with10% undiluted Povidone Iodine solution without mobbing before closure of subcutaneous tissues

Drug: Povidone iodine

No intervention group

NO INTERVENTION

No swabbing of subcutaneous tissue of cesarean section wounds

Interventions

Povidone iodine DRUG

After closure of the anterior wall of the rectus sheath, the subcutaneous tissues of the cesarean section wound will be swabbed with 10% undiluted Povidone iodine without mobbing.

Also known as: Betadine

Betadine group

Eligibility Criteria

• Age: 20 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• All women having either first time or repeat cesarean section whether elective or emergency.

You may not qualify if:

• Women with prolonged rupture of membranes more than 12 hours.
• Women with morbid obesity with BMI\>35.
• Women with diabetes, hypertension or anemia with hemoglobin\<9.
• Women on corticosteroid therapy or immunosuppressed women.
• Women with intraoperative hemorrhage or hematoma formation.
• Women allergic to betadine.
• The cesarean section which duration exceed one hour or associated with other surgical procedure.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Wound Infection

Interventions

Povidone-Iodine

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, OB-GYN department- Principal investigator

Study Record Dates

• First Submitted: July 29, 2016
• First Posted: August 16, 2016
• Study Start: September 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: August 16, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share