Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03725748 |
| Other study ID # |
assistant professor2 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2018 |
| Est. completion date |
June 2019 |
Study information
| Verified date |
October 2018 |
| Source |
Kasr El Aini Hospital |
| Contact |
hany saad, assistant prof |
| Phone |
01001817211 |
| Email |
dr_hanysaad[@]yahoo.co.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
