Surgical Wound InfectionNCT06491381
Post Cesarian Section Wound Infections At Emergency Room
An observational study of Surgical Wound Infection, run by Al-Azhar University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Surgical Wound Infection
- What is being tested?
- Cesarean delivery
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 220 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: 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.
Who may be able to join
- Age > 18
- Managed with elective CS or Emergency CS
- BMI < 25 Kg/m2
Who cannot join
- Immunodeficiency or diabetes.
- Premature rupture of membrane
- Bleeding disorder.
- Previous uterine surgery except previous CS.
- Malignancy.
- Refusal to participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Post Cesarean Section Wound Infections At Emergency Unit At E-Hhussien University Hospital
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?
Read more
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.
- Conditions
- Surgical Wound Infection
- Being tested
- Cesarean delivery
- Keywords
- Surgical site infections, Elective Cesarean delivery, Emergency Room
- Medical subject headings
- Surgical Wound Infection, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cesarean deliveryProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Elective 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. Receives: Procedure: Cesarean delivery | |
| Emergency 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. Receives: Procedure: Cesarean delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks after surgery.
Secondary outcomes (6)
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).
Measured: 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.
Measured: 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.
Measured: 6 weeks after surgery.
Antibiotic Usage
We will measure the frequency, type, and duration of antibiotic administration to treat post-cesarean section wound infections.
Measured: 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.
Measured: 6 weeks after surgery.
Keloid formation
We will assess formation of keloid after the surgery/
Measured: 6 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start1 May 2023
- Primary completion30 Jul 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Wound InfectionStudies of the same condition, open and under way.
- More trials run by Al-Azhar UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491381
- Sponsor's protocol ID
- obstet1724
- Status last verified
- Feb 2025
- First submitted
- 1 Jul 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Post Cesarean Section Wound Infections At Emergency Unit At E-Hhussien University Hospital
- ClinicalTrials.gov ID
- NCT06491381
- Acronym / sponsor ID
- obstet1724
- Conditions
- Surgical Wound Infection
- Keywords
- Surgical site infections, Elective Cesarean delivery, Emergency Room
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elective Cesarean Delivery | – | Procedure: Cesarean deliveryThis 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. |
| Emergency Cesarean Delivery | – | Procedure: Cesarean deliveryThis 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- Age > 18
- Managed with elective CS or Emergency CS
- BMI < 25 Kg/m2
Key exclusion criteria (6 listed)
- Immunodeficiency or diabetes.
- Premature rupture of membrane
- Bleeding disorder.
- Previous uterine surgery except previous CS.
- Malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cesarean deliveryThe 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. | Procedure or surgery | Elective Cesarean Delivery, Emergency Cesarean Delivery |
Primary outcome
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.
6 secondary outcomes
Wound Healing Complications
Time frame: 6 weeks after surgery.
Length of Hospital Stay
Time frame: 6 weeks after surgery.
Surgical Site Pain
Time frame: 6 weeks after surgery.
Antibiotic Usage
Time frame: 6 weeks after surgery.
Patient Satisfaction
Time frame: 6 weeks after surgery.
Keloid formation
Time frame: 6 months after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgical Wound Infection, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Caesarian Section Wound Infections (time frame: 6 weeks after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2025.