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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05164224
Other study ID # 12/2020 BSGN 14
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date March 1, 2022

Study information

Verified date December 2021
Source Menoufia University
Contact Mohamed E Anter, MD
Phone 01224462910
Email mohamedsibai681@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


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


Recruitment information / eligibility

Status Recruiting
Enrollment 64
Est. completion date March 1, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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.

Study Design


Locations

Country Name City State
Egypt Menoufia University hospital Shibin Al Kawm Menoufia

Sponsors (1)

Lead Sponsor Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 2 weeks
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04359472 - The Collection and Application of Autologous Amniotic Fluid at Cesarean Delivery Closure. N/A
Completed NCT03968783 - The Effect of Suturing Material on Scar Healing N/A
Not yet recruiting NCT03111706 - 2D and 3D Ultrasound Assessment of Cesarean Section Scars N/A
Completed NCT03223233 - Predicting the Severity of Post-cesarean Wound Infections Using Serum Procalcitonin Levels N/A
Completed NCT03851003 - The Influence of Endometrial Suturing on the Risk of Uterine Scar Defect N/A
Completed NCT04587960 - Delayed Primary Closure of Skin in Emergency Caesarean Section N/A
Recruiting NCT03966001 - Cesarean Scar Defect Formation After First Cesarean Section.
Completed NCT03414762 - PICO Negative Pressure Wound Therapy in Obese Women Undergoing Elective Cesarean Delivery. Phase 3