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Swabbing of Subcutaneous Tissues of Cesarean Section Wounds With Povidone Iodine

2016-08-17 10:53:22 | BioPortfolio

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.

Study Design

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

Conditions

Wound Infection

Intervention

Povidone iodine

Status

Not yet recruiting

Source

Assiut University

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-08-17T10:53:22-0400

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Medical and Biotech [MESH] Definitions

An iodinated polyvinyl polymer used as topical antiseptic in surgery and for skin and mucous membrane infections, also as aerosol. The iodine may be radiolabeled for research purposes.

Preparations used as alternatives or supplements to hand washing with soap and water to destroy microorganisms and prevent transmission of pathogens. The active ingredient may be ETHANOL; 1-PROPANOL; or POVIDONE-IODINE in a gel, foam, or liquid solution.

The application of a vacuum across the surface of a wound through a foam dressing cut to fit the wound. This removes wound exudates, reduces build-up of inflammatory mediators, and increases the flow of nutrients to the wound thus promoting healing.

Stable iodine atoms that have the same atomic number as the element iodine, but differ in atomic weight. I-127 is the only naturally occurring stable iodine isotope.

Unstable isotopes of iodine that decay or disintegrate emitting radiation. I atoms with atomic weights 117-139, except I 127, are radioactive iodine isotopes.

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