Serum Procalcitonin and Post-cesarean Wound Infection

Sponsor
Menoufia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05164224
Collaborator
(none)
64
1
13.9
4.6

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    64 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Correlation of Serum Procalcitonin and Severity of Post-cesarean Wound Infection
    Actual Study Start Date :
    Jan 1, 2021
    Anticipated Primary Completion Date :
    Jan 1, 2022
    Anticipated Study Completion Date :
    Mar 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Serum procalcitonin levels in participants who will developwound infection after cesarean sections [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Inclusion Criteria:
    • patients who will develop surgical site infection after their cesarean sections.

    • 18-40 years old

    Exclusion Criteria:
    • History of chorioamnionitis, premature rupture of membranes or prolonged rupture of membrane.

    • Urinary tract infections.

    • Any infectious condition other than surgical site infection.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Menoufia University hospital Shibīn Al Kawm Menoufia Egypt 11111

    Sponsors and Collaborators

    • Menoufia University

    Investigators

    • Study Director: Mohamed E Anter, MD, Menoufia University-Shebin Elkom-Egypt

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mohamed Elsibai Anter, Assistant professor of obstetrics and gynecology, Menoufia University
    ClinicalTrials.gov Identifier:
    NCT05164224
    Other Study ID Numbers:
    • 12/2020 BSGN 14
    First Posted:
    Dec 20, 2021
    Last Update Posted:
    Dec 20, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 20, 2021