Cesarean Wound DisruptionNCT05164224
Serum Procalcitonin and Post-cesarean Wound Infection
An observational study of Cesarean Wound Disruption, run by Menoufia University at 1 site in Egypt.
Trial summary
serum procalcitonin levels are important during infections and sepsis.The aim of this study is to evaluate the correlation between serum procalcitonin and severity of post cesarean wound infection Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Cesarean Wound Disruption
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Mar 2022
- 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
- Adult
Study population: patients who will develop surgical site infection after their cesarean sections
Who may be able to join
- patients who will develop surgical site infection after their cesarean sections.
- 18-40 years old
Who cannot join
- History of chorioamnionitis, premature rupture of membranes or prolonged rupture of membrane.
- Urinary tract infections.
- Any infectious condition other than surgical site infection.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Menoufia University hospital
Shibīn al Kawm, Menoufia, 11111
Mohamed Elsibai Anter, MD, +20-048-2070065, Mohamedsibai681@yahoo.com
About this study
Official title: Correlation of Serum Procalcitonin and Severity of Post-cesarean Wound Infection
serum procalcitonin levels are important during infections and sepsis.The aim of this study is to evaluate the correlation between serum procalcitonin and severity of post cesarean wound infection
Read the detailed description
Bacterial infection is primarily a clinical concept that may require the use of supportive bedside or laboratory tests to confirm or exclude. There are two broad factors that are always necessary to confirm the diagnosis: inflammation or systemic dysfunction and direct or indirect evidence of a compatible bacterial pathogen. Inflammation may be localized or result in a systemic inflammatory response syndrome (SIRS).
Infection handling and prevention are now improving with an effective antibiotic discovery, complete immunization and modern sanitation. However, infection remains the most common cause of morbidity and mortality rate in many health care services in the world.
One of the most often serious complications in surgical procedure is surgical site infection. Surgical site infection (SSI) is defined as the presence of liquid pus or abscess which extends on a wound within 30day (RCOG Press, 2008; Bratzlr et al.,2006). Surgical site infection is diagnosed with clinical and laboratory examination. The diagnosis begins with an inspection to check any pus, abscess or inflammation reaction extends on the surgical site. An open wound is also being checked, as well as pus liquid or abscess that leaks from thewound. Pus or tissue specimen should be taken for culture examination and routine blood count for leucocyte count should be investigated and procalcitonin level Procalcitonin (PCT) and leucocyte count are indicators of systemic infection. Procalcitonin is one of the applicable markers to detect bacterial infection in adults. Plasma PCT level is comparable with specific response of bacterial infection, particularly for invasive or probably-invasive bacteria. High concentration of PCT indicates sepsis, severe sepsis or even septic shock condition. It may also represent another possibility and gives additional information towards conventional clinical data. Some studies state that procalcitonin is better, or at least has the same diagnosis potency with another infection marker such as CRP, leukocytosis and fever
- Conditions
- Cesarean Wound Disruption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No secondary suture | The participants who will develop post-cesarean surgical site infection and follow-up only antibiotic treatment for their wound care. | |
| secondary suture | The participants who will develop post-cesarean surgical site infection and need a secondary suture for their wound care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum procalcitonin levels in participants who will developwound infection after cesarean sections
Serum procalcitonin levels will be measured in participants who will develop post-cesarean wound site infections. The serum procalcitonin levels will be compared in subgroups (who need secondary suture and those who willn't require suturing)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start1 Jan 2021
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Wound DisruptionStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Cross-sectional
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Elsibai Anter, Menoufia University
- Investigators
- Mohamed E Anter, MD, Study director, Menoufia University-Shebin Elkom-Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05164224
- Sponsor's protocol ID
- 12/2020 BSGN 14
- Status last verified
- Dec 2021
- First submitted
- 5 Dec 2021
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Serum Procalcitonin and Severity of Post-cesarean Wound Infection
- ClinicalTrials.gov ID
- NCT05164224
- Acronym / sponsor ID
- 12/2020 BSGN 14
- Conditions
- Cesarean Wound Disruption
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 20 Dec 2021 (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.
serum procalcitonin levels are important during infections and sepsis.The aim of this study is to evaluate the correlation between serum procalcitonin and severity of post cesarean wound infection
Detailed description
Bacterial infection is primarily a clinical concept that may require the use of supportive bedside or laboratory tests to confirm or exclude. There are two broad factors that are always necessary to confirm the diagnosis: inflammation or systemic dysfunction and direct or indirect evidence of a compatible bacterial pathogen. Inflammation may be localized or result in a systemic inflammatory response syndrome (SIRS).
Infection handling and prevention are now improving with an effective antibiotic discovery, complete immunization and modern sanitation. However, infection remains the most common cause of morbidity and mortality rate in many health care services in the world.
One of the most often serious complications in surgical procedure is surgical site infection. Surgical site infection (SSI) is defined as the presence of liquid pus or abscess which extends on a wound within 30day (RCOG Press, 2008; Bratzlr et al.,2006). Surgical site infection is diagnosed with clinical and laboratory examination. The diagnosis begins with an inspection to check any pus, abscess or inflammation reaction extends on the surgical site. An open wound is also being checked, as well as pus liquid or abscess that leaks from thewound. Pus or tissue specimen should be taken for culture examination and routine blood count for leucocyte count should be investigated and procalcitonin level Procalcitonin (PCT) and leucocyte count are indicators of systemic infection. Procalcitonin is one of the applicable markers to detect bacterial infection in adults. Plasma PCT level is comparable with specific response of bacterial infection, particularly for invasive or probably-invasive bacteria. High concentration of PCT indicates sepsis, severe sepsis or even septic shock condition. It may also represent another possibility and gives additional information towards conventional clinical data. Some studies state that procalcitonin is better, or at least has the same diagnosis potency with another infection marker such as CRP, leukocytosis and fever
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No secondary suture | – | –The participants who will develop post-cesarean surgical site infection and follow-up only antibiotic treatment for their wound care. |
| secondary suture | – | –The participants who will develop post-cesarean surgical site infection and need a secondary suture for their wound care |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- patients who will develop surgical site infection after their cesarean sections
Key inclusion criteria (2 listed)
- patients who will develop surgical site infection after their cesarean sections.
- 18-40 years old
Key exclusion criteria (3 listed)
- History of chorioamnionitis, premature rupture of membranes or prolonged rupture of membrane.
- Urinary tract infections.
- Any infectious condition other than surgical site infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum procalcitonin levels in participants who will developwound infection after cesarean sections
Time frame: 2 weeks
Serum procalcitonin levels will be measured in participants who will develop post-cesarean wound site infections. The serum procalcitonin levels will be compared in subgroups (who need secondary suture and those who willn't require suturing)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- Individual participant dataSharing planned: Yes
Related trials for Cesarean Wound Disruption
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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.
Mohamed E Anter, MD study director
Menoufia University-Shebin Elkom-Egypt
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 Cesarean Wound Disruption, run by Menoufia 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Dec 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed E Anter, MD (01224462910, mohamedsibai681@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum procalcitonin levels in participants who will developwound infection after cesarean sections (time frame: 2 weeks). 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 20 Dec 2021.