An interventional study of Povidone iodine in Wound Infection, sponsored by Assiut University. Status unknown. Open to female participants aged 20 Years to 43 Years. Per ClinicalTrials.gov, last updated 2016-08-16.
Sponsored by Assiut University · Not applicable, Interventional, and Prevention
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.
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 :
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:
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 538 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Subcutaneous tissues of cesarean section wounds are swabbed with10% undiluted Povidone Iodine solution without mobbing before closure of subcutaneous tissues
Drug: Povidone iodine
No swabbing of subcutaneous tissue of cesarean section wounds
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.
Also known as: Betadine
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
Time frame: One month
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Assiut University