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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02868372
Other study ID # AUH2
Secondary ID
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


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
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