Swabbing of Subcutaneous Tissues of Cesarean Section Wounds With Povidone Iodine

Wound Infection Clinical Trial

Official title:

The Efficacy of Swabbing of Subcutaneous Tissues of Cesarean Section Wounds With Povidone Iodine to Prevent Postoperative Wound Infection: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02868372
• Other study ID #: AUH2
• Status: Not yet recruiting
• Phase: N/A
• First received: July 29, 2016
• Last updated: August 14, 2016
• Start date: September 2016
• Est. completion date: April 2017

Study information

• Verified date: August 2016
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 538
• Est. completion date: April 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 43 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection
• Wound Infection
• Wounds and Injuries

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes