Predicting the Severity of Post-cesarean Wound Infections Using Serum Procalcitonin Levels

Wound Infection Clinical Trial

Official title:

Predicting the Severity of Post-cesarean Wound Infections Using Serum Procalcitonin Levels

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03223233
• Other study ID #: 2016/12.2
• Status: Completed
• Phase: N/A
• First received: July 17, 2017
• Last updated: October 22, 2017
• Start date: May 2, 2017
• Est. completion date: October 8, 2017

Study information

• Verified date: October 2017
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The serum procalcitonin levels are important during infections and sepsis. The investigators aimed to assess its predictive value in terms of post-cesarean wound infection.

Description:

The serum procalcitonin levels are important during infections and sepsis. Recent studies showed that serum procalcitonin levels are more sensitive than serum CRP levels.The investigators aimed to assess its predictive value in terms of post-cesarean wound infection. The serum procalcitonin levels are aimed to measure in participants who had cesarean section and developed surgical site infection. The investigators aimed to compare the serum procalcitonin levels between the patients who need secondary suture and the patients who did not need secondary suture.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 8, 2017
• Est. primary completion date: September 29, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• who developed surgical site infection after their cesarean sections.

• 18-40 years old

Exclusion Criteria:

• history of chorioamnionitis and premature rupture of membranes

• urinary tract infections

• any infectious condition other than surgical site infection

Related Conditions & MeSH terms

• Cesarean Wound Disruption
• Communicable Diseases
• Infection
• Wound Infection
• Wounds and Injuries

Intervention

Other:
• procalcitonin level
serum procalcitonin level will be measured in both groups.

Locations

Country	Name	City	State
Turkey	Kanuni SSRTH	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Erenel H, Yilmaz N, Oncul M, Acikgoz AS, Karatas S, Ayhan I, Aslan B, Tuten A. Usefulness of Serum Procalcitonin Levels in Predicting Tubo-Ovarian Abscess in Patients with Acute Pelvic Inflammatory Disease. Gynecol Obstet Invest. 2017;82(3):262-266. doi: — View Citation

Takakura Y, Hinoi T, Egi H, Shimomura M, Adachi T, Saito Y, Tanimine N, Miguchi M, Ohdan H. Procalcitonin as a predictive marker for surgical site infection in elective colorectal cancer surgery. Langenbecks Arch Surg. 2013 Aug;398(6):833-9. doi: 10.1007/s00423-013-1095-0. Epub 2013 Jun 20. — View Citation

Wacker C, Prkno A, Brunkhorst FM, Schlattmann P. Procalcitonin as a diagnostic marker for sepsis: a systematic review and meta-analysis. Lancet Infect Dis. 2013 May;13(5):426-35. doi: 10.1016/S1473-3099(12)70323-7. Epub 2013 Feb 1. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum procalcitonin levels in participants who developed wound 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 don't require suturing	5 months