A Phase 2 interventional study of irrigation in Incidence of cs Scar Infection, sponsored by Kasr El Aini Hospital. Status unknown at 1 site in Egypt. Open to female participants aged 19 Years to 37 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-31.
Sponsored by Kasr El Aini Hospital · Phase 2, Interventional, and Prevention
This is a prospective randomized controlled study to the difference between using normal saline or betadine irrigation of wound prior to skin closure in reducing the incidence of wound infection after Cesarean section.
This study will be conducted at the Department of Obstetrics \& Gynecology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University, from February to July 2018.
We include in our study 3oo pregnant women who will undergo Cesarean section. All participants will be divided into 3 groups with a 1:1:1 ratio with 100 patients in each group. Each participant will provide an informed written consent.
Consenting patients will be pre-operatively randomised using numerically ordered cards in sealed envelopes to either the group 1 (wound irrigation with 100 ml of normal saline before skin closure) or the group 2 (wound irrigation with 50 ml of 10% aqueous povidone iodine solution ̋ Betadinȅ ) or the control group (no wound irrigation with normal saline nor betadine).Subjects candidate for the study will be 37 weeks' gestation and require a cesarean section (elective or emergency). Patients with allergy to iodine, history of immunosuppressive drug use, gestationaldiabetes mellitus or preeclampsia, anemic patients, ruptured of membranes and feverish patients will be excluded from the study.
The primary outcome will be the incidence of wound infection. Wound infection is diagnosed when the wound drained purulent material or serosanguineous fluid in association with induration, warmth and tenderness. Suspected wound infections are opened for confirmation and wound cultures will be taken. Haematoma, seroma, or wound breakdown in the absence of the previouslydiscussed signs is not considered a wound infection.Wounds are examined twice daily during hospitalization for evidence of infection. After discharge, the women are instructed on the signs and symptoms of wound infection, and asked to contact one of the co-authors immediately if any of the listed symptoms appeared. All participants are examined at 2 and 6 weeks after surgery.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 300 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Kasr El Aini Hospital is the lead sponsor of 273 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
nothing used for irrigation of cs scar
saline used for irrigation the cs scar before closure
Other: irrigation
betadine used for irrigation of cs scar
Other: irrigation
irrigation the edges of the cs scar before closure
incidence of cs scar infection
incidence of cs scar infection
Time frame: 2 to 6 weeks
incidence of hematoma, seroma
incidence of hematoma, seroma, wound breakdown
Time frame: 2 to 6 weeks
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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Kasr El Aini Hospital