Swabbing of Subcutaneous Tissues of Cesarean Section Wounds With Povidone Iodine
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|ClinicalTrials.gov Identifier: NCT02868372|
Recruitment Status : Not yet recruiting
First Posted : August 16, 2016
Last Update Posted : August 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Wound Infection||Drug: Povidone iodine||Not Applicable|
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.
- 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:
- 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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||538 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||April 2017|
Active Comparator: Betadine group
Subcutaneous tissues of cesarean section wounds are swabbed with10% undiluted Povidone Iodine solution without mobbing before closure of subcutaneous tissues
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.
Other Name: Betadine
No Intervention: No intervention group
No swabbing of subcutaneous tissue of cesarean section wounds
- Detect and record the incidence of surgical wound infection in both groups [ Time Frame: One month ]: 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