Serum Procalcitonin and Post-cesarean Wound Infection

Cesarean Wound Disruption Clinical Trial

Official title:

Correlation of Serum Procalcitonin and Severity of Post-cesarean Wound Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05164224
• Other study ID #: 12/2020 BSGN 14
• Status: Recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Cesarean Wound Disruption
• Wound Infection
• Wounds and Injuries

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