An observational study in Surgical Wound Infection, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-02-12.
Sponsored by Al-Azhar University · Observational
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 220 is close to the median of 240 across 2,136 observational studies indexed under Infections.
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This study will include 220 patients undergoing cesarean section at El-hussien Hospital, equally divided into two groups of 110 each. One group will consist of emergency cesarean deliveries performed in the Emergency Unit, excluding cases with premature rupture of membranes. The other group will include elective, scheduled cesarean deliveries. This diverse population will allow for a comprehensive comparison of surgical site infection rates and other outcomes between emergency and elective cesarean sections.
Exclusion Criteria:
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.
Procedure: 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.
Procedure: Cesarean delivery
The cesarean section will begin with a Pfannenstiel incision above the pubic bone, followed by blunt dissection to separate tissue layers and retracting the rectus muscles for peritoneal cavity access. A transverse or vertical peritoneal incision will expose the uterus, and a transverse incision on the lower uterine segment will be made for delivery. The baby will be delivered, the umbilical cord clamped and cut, and the baby handed to the pediatric team. The placenta will be detached and delivered, and the uterus will be closed with multiple layers of sutures. The abdominal layers will be closed with absorbable Polyglactin (Vicryl) sutures for the rectus sheath and subcutaneous tissue, and non-absorbable Polypropylene sutures for the skin. A sterile dressing will be applied to protect the wound and promote a clean healing environment, ensuring proper surgical technique, tissue handling, and minimizing post-operative complications.
Post Caesarian Section Wound Infections
* 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.
Time frame: 6 weeks after surgery.
Wound Healing Complications
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).
Time frame: 6 weeks after surgery.
Length of Hospital Stay
We will measure the duration of hospitalization for patients who undergo a cesarean section at the emergency unit and hospital.
Time frame: 6 weeks after surgery.
Surgical Site Pain
We will evaluate the intensity and duration of pain experienced by patients at the surgical site following a cesarean section.
Time frame: 6 weeks after surgery.
Antibiotic Usage
We will measure the frequency, type, and duration of antibiotic administration to treat post-cesarean section wound infections.
Time frame: 6 weeks after surgery.
Patient Satisfaction
We will assess the level of satisfaction reported by patients regarding their overall experience with the cesarean section procedure and subsequent wound healing.
Time frame: 6 weeks after surgery.
Keloid formation
We will assess formation of keloid after the surgery/
Time frame: 6 months after the surgery
Plan to share: Yes — We plan to share de-identified individual participant data (IPD) from this study. The shared data will include baseline demographics, clinical characteristics, surgical details, and outcome measures related to surgical site infections and other relevant outcomes for both emergency and elective cesarean section groups. Data will be available beginning 9 months after the main study results are published. Researchers who provide a methodologically sound proposal will be allowed access to the data. Proposals should be directed to the corresponding author. The corresponding author will also be responsible for making the data available to approved researchers. To gain access, data requestors will need to sign a data access agreement. The data will be available for 5 years for researchers whose proposed use of the data has been approved. The shared dataset will exclude participant identifying information and comply with privacy regulations.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Al-Azhar University