Swabbing of Subcutaneous Tissues of Cesarean Section Wounds With Povidone Iodine

NCT ID: NCT02868372

Last Updated: 2016-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 538 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-04-30

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.

Detailed Description

Aim of the study:

To assess the efficacy of subcutaneous swabbing of cesarean section wounds with povidone iodine to prevent postoperative wound infection.

Study Design: Randomized controlled trial.

Subjects: Women having a cesarean delivery.

The women will have a full description of the study and Subjects will be randomized by selecting a sequentially numbered sealed envelope to one of each group which will be opened during closure of rectus sheath.

Method :

• Patient will receive single dose of prophylactic antibiotic (2-grams first generation cephalosporin) intravenous at time of cesarean delivery during induction of anesthesia. -The same type of suturing material; vicryl No1 will be used for rectus Sheath repair in both groups.
• The same type of suturing material will be used to suture the subcutaneous tissue and the skin (vicryl NO 2/0).

Follow up : 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.

Outcome :The study outcome is to detect and record the incidence of surgical wound infection in both groups.It is a composite outcome with presence of any of the following is considered infection:

• Induration
• Swelling of the wound edges
• Discharge of pus or wound dehiscence.
• Purulent drainage with or without laboratory confirmation, from the superficial incision
• Pain or tenderness with redness, or heat
• Superficial incision being deliberately opened by surgeon.

Sample size estimation:

It was calculated that 269 patients are required in each arm to detect a 5% reduction (from 7% to 2%) in cesarean section wound infection rates between study and control groups.

Statistical Analysis:

Data will be tabulated using Statistical Package for Social Scientists (SPSS) program and statistical analysis will be carried out with suitable statistical tests. Continuous variables will be presented as mean and standard deviation, and will be compared using Student-t-test. Dichotomous variables will be compared using Chi square and the cut off point for P-value will be less than 0.05.

Conditions

Wound Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Betadine group

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

Group Type: ACTIVE_COMPARATOR

Povidone iodine

Intervention Type: 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.

No intervention group

No swabbing of subcutaneous tissue of cesarean section wounds

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Povidone iodine

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.

Intervention Type: DRUG

Other Intervention Names

Betadine

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 43 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Essam Rashad Abdel-Hafeez Othman

Associate professor, OB-GYN department- Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

AUH2

Identifier Type: -

Identifier Source: org_study_id