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CompletedNCT03223233Updated Oct 24, 2017

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

An observational study in Wound Infection and Cesarean Wound Disruption, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2017-10-24.

Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
90
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Wound Infection
  • Cesarean Wound Disruption

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03

In context

Wound Infection

388 studies on the registry are indexed under Wound Infection; 40 are open to participants now.

This study's enrollment of 90 is below the median of 217 across 66 observational studies indexed under Wound Infection.

Browse Wound Infection studies →

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital is the lead sponsor of 224 studies on the registry; 34 are open to participants now.

Browse Kanuni Sultan Suleyman Training and Research Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The participants are post-cesarean patients who developed surgical site infections.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • who developed surgical site infection after their cesarean sections.
  • 18-40 years old

Exclusion criteria

Exclusion Criteria:

  • history of chorioamnionitis and premature rupture of membranes
  • urinary tract infections
  • any infectious condition other than surgical site infection
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
90 participants (actual)
Target follow-up
2 Weeks
Patient registry
Yes

Groups and cohorts

  • No secondary suture

    The participants who developed post-cesarean surgical site infection and follow-up only antibiotic treatment for their wound care.

    Other: procalcitonin level

  • Secondary suture

    The participants who developed post-cesarean surgical site infection and need a secondary suture for their wound care

    Other: procalcitonin level

Interventions

  • Otherprocalcitonin level

    serum procalcitonin level will be measured in both groups.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 5 months

07

Study locations

1 site
  • Kanuni SSRTH
    Istanbul, 34303, Turkey (Türkiye)
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References and documents

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. PubMed 23375419 ↗
  • 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. PubMed 23784676 ↗
  • 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. PubMed 27592364 ↗
  • 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. PubMed 29804483 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2017 to primary completion in Sep 2017, 4 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 17, 2017
First posted
Jul 21, 2017
StartActual
May 2, 2017
Primary completionActual
Sep 29, 2017
CompletionActual
Oct 8, 2017
Last update
Oct 24, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03223233
Lead sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Responsible party
Berna Aslan Cetin (MD,ObGYN, Kanuni Sultan Suleyman Training and Research Hospital) — Principal investigator
First posted
Jul 21, 2017
Start date
May 2, 2017
Primary completion
Sep 29, 2017
Completion
Oct 8, 2017
Last update
Oct 24, 2017

Study contacts

Alev Atis, MD,ObGyn
study director · Kanuni Sultan Suleyman Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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