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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Betadine group | Active Comparator | Subcutaneous tissues of cesarean section wounds are swabbed with10% undiluted Povidone Iodine solution without mobbing before closure of subcutaneous tissues |
|
| No intervention group | No Intervention | No swabbing of subcutaneous tissue of cesarean section wounds |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Povidone iodine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D014946 | Wound Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D011206 | Povidone-Iodine |
| ID | Term |
|---|---|
| D007466 | Iodophors |
| D017613 | Iodine Compounds |
| D007287 | Inorganic Chemicals |
| D011145 | Polyvinyls |
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|
| D014753 |
| Vinyl Compounds |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011205 | Povidone |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |