Wound Infection Clinical Trial
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
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 :
- 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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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