Normal Saline Versus Betadine Use to Reduce the Incidence of Wound Infection in Cesarean Section
NCT ID: NCT03725748
Last Updated: 2018-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
300 participants
INTERVENTIONAL
2018-11-01
2019-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
no irrigation group
nothing used for irrigation of cs scar
No interventions assigned to this group
saline irrigation group
saline used for irrigation the cs scar before closure
irrigation
irrigation the edges of the cs scar before closure
betadine irrigation group
betadine used for irrigation of cs scar
irrigation
irrigation the edges of the cs scar before closure
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
irrigation
irrigation the edges of the cs scar before closure
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* require a cesarean section (elective or emergency).
Exclusion Criteria
* history of immunosuppressive drug use,
* gestationaldiabetes mellitus
* preeclampsia
* anemic patients
* ruptured of membranes
* feverish patients
19 Years
37 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Kasr El Aini Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
hadeer meshal
assistant prfessor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
fady salah, lecturer
Role: STUDY_DIRECTOR
Director
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Kasr El Ainy
Cairo, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
mohamed saad, lecturer
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
assistant professor2
Identifier Type: -
Identifier Source: org_study_id