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Completed

NCT Number: NCT06491381

Post Cesarian Section Wound Infections At Emergency Room

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.

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Key information

Conditions

Surgical Wound Infection Disease Attributes Emergencies Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Wound Infection

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Al-Hussein University Hospital

Cairo, Cairo Governorate, 11633, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cesarean Delivery

Procedure

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.

Primary outcomes

  1. Post Caesarian Section Wound Infections

    Time frame: 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 outcomes

  1. Wound Healing Complications

    Time frame: 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).

  2. Length of Hospital Stay

    Time frame: 6 weeks after surgery.

    We will measure the duration of hospitalization for patients who undergo a cesarean section at the emergency unit and hospital.

  3. Surgical Site Pain

    Time frame: 6 weeks after surgery.

    We will evaluate the intensity and duration of pain experienced by patients at the surgical site following a cesarean section.

  4. Antibiotic Usage

    Time frame: 6 weeks after surgery.

    We will measure the frequency, type, and duration of antibiotic administration to treat post-cesarean section wound infections.

  5. Patient Satisfaction

    Time frame: 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.

  6. Keloid formation

    Time frame: 6 months after the surgery

    We will assess formation of keloid after the surgery/

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Incidence of Post Cesarean Section Wound Infections At Emergency Unit At E-Hhussien University Hospital

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 9, 2024
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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