Post Cesarian Section Wound Infections At Emergency Room

Completed

• Conditions: Surgical Wound Infection
• Interventions: Procedure: Cesarean delivery

• Registration Number: NCT06491381
• Lead Sponsor: Al-Azhar University

Brief Summary

The goal of this observational study is to compare the incidence of post-cesarean section wound infections between emergency and elective cesarean deliveries at El-hussien Hospital. The main questions it aims to answer are:

Is there a difference in surgical site infection rates between emergency and elective cesarean sections? What are the other outcome measures associated with emergency versus elective cesarean deliveries?

Participants will be 220 patients undergoing cesarean section, divided into two groups:

110 patients undergoing emergency cesarean delivery in the Emergency Unit 110 patients undergoing elective cesarean delivery

Researchers will compare the emergency cesarean group to the elective cesarean group to see if there are differences in surgical site infection rates and other relevant outcome measures.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-01
• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-01
• Study First Posted: 2024-07-09
• Primary Completion: 2024-07-30
• Study Completion: 2024-08-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 220

Inclusion Criteria

• Age > 18
• Managed with elective CS or Emergency CS
• BMI < 25 Kg/m2

Exclusion Criteria

• Immunodeficiency or diabetes.
• Premature rupture of membrane
• Bleeding disorder.
• Previous uterine surgery except previous CS.
• Malignancy.
• Refusal to participate.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Emergency Cesarean Delivery	Cesarean delivery	This group will consist of 110 patients who undergo unplanned, emergency cesarean deliveries at the Emergency Unit of El-hussien Hospital. Indications for emergency cesarean section may include, but are not limited to, fetal distress, placental abruption, cord prolapse, failed induction of labor, or arrest of labor progression. Patients with premature rupture of membranes will be excluded from this group due to their increased risk of infection. Participants in this group will receive urgent pre-operative preparation and post-operative care as per hospital emergency protocols. Their surgical sites will be monitored for signs of infection during their hospital stay and follow-up period, similar to the elective group.
Elective Cesarean Delivery	Cesarean delivery	This group will consist of 110 patients who are scheduled for planned cesarean deliveries at El-hussien Hospital. These patients will have non-emergency indications for cesarean section, such as previous cesarean delivery, breech presentation, maternal request, or other medical indications that allow for scheduled surgery. Participants in this group will undergo standard pre-operative preparation and receive routine post-operative care as per hospital protocols. Their surgical site will be monitored for signs of infection during their hospital stay and follow-up period.

Primary Outcome Measures

Name	Time	Method
Post Caesarian Section Wound Infections	6 weeks after surgery.	* The wounds will be inspected. The presence of minor or major wound infection will be recorded on an audit form.; * Wound infection will be defined as: Purulent discharge present within or exuding from the wound. Painful spreading erythema indicative of cellulitis.; • An infection will be defined as minor if deep tissue destruction or lymphangitis is absent, and major if these elements, wound dehiscence or systemic symptoms, is present.

Secondary Outcome Measures

Name	Time	Method
Surgical Site Pain	6 weeks after surgery.	We will evaluate the intensity and duration of pain experienced by patients at the surgical site following a cesarean section.
Antibiotic Usage	6 weeks after surgery.	We will measure the frequency, type, and duration of antibiotic administration to treat post-cesarean section wound infections.
Patient Satisfaction	6 weeks after surgery.	We will assess the level of satisfaction reported by patients regarding their overall experience with the cesarean section procedure and subsequent wound healing.
Wound Healing Complications	6 weeks after surgery.	We will assess the occurrence of other wound-related complications, such as wound dehiscence (separation of wound edges), seroma (accumulation of fluid), or hematoma (collection of blood).
Length of Hospital Stay	6 weeks after surgery.	We will measure the duration of hospitalization for patients who undergo a cesarean section at the emergency unit and hospital.
Keloid formation	6 months after the surgery	We will assess formation of keloid after the surgery/

Trial Locations

Locations (1)

Al-Hussein University Hospital; 🇪🇬 Cairo, Egypt