- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03223233
Predicting the Severity of Post-cesarean Wound Infections Using Serum Procalcitonin Levels
October 22, 2017 updated by: Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Istanbul, Turkey, 34303
- Kanuni SSRTH
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
The participants are post-cesarean patients who developed surgical site infections.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
No secondary suture
The participants who developed post-cesarean surgical site infection and follow-up only antibiotic treatment for their wound care.
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serum procalcitonin level will be measured in both groups.
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Secondary suture
The participants who developed post-cesarean surgical site infection and need a secondary suture for their wound care
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serum procalcitonin level will be measured in both groups.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Serum procalcitonin levels in participants who developed wound infection after cesarean sections
Time Frame: 5 months
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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
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5 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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: 10.1159/000449161. Epub 2016 Sep 3.
- Aslan Cetin B, Aydogan Mathyk B, Koroglu N, Temel Yuksel I, Konal M, Erenel H, Atis Aydin A. Serum procalcitonin levels in incisional surgical site infections requiring a secondary suture after cesarean sections. J Matern Fetal Neonatal Med. 2019 Dec;32(24):4108-4113. doi: 10.1080/14767058.2018.1481949. Epub 2018 Jun 20.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 2, 2017
Primary Completion (ACTUAL)
September 29, 2017
Study Completion (ACTUAL)
October 8, 2017
Study Registration Dates
First Submitted
July 17, 2017
First Submitted That Met QC Criteria
July 18, 2017
First Posted (ACTUAL)
July 21, 2017
Study Record Updates
Last Update Posted (ACTUAL)
October 24, 2017
Last Update Submitted That Met QC Criteria
October 22, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/12.2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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