NCT03223233

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2017

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 8, 2017

Completed
Last Updated

October 24, 2017

Status Verified

October 1, 2017

Enrollment Period

5 months

First QC Date

July 17, 2017

Last Update Submit

October 22, 2017

Conditions

Wound InfectionCesarean Wound Disruption

Outcome Measures

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

    5 months

Study Arms (2)

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

procalcitonin levelOTHER

serum procalcitonin level will be measured in both groups.

No secondary sutureSecondary suture

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatients who underwent cesarean section
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni SSRTH

Istanbul, 34303, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 23375419BACKGROUND

  • 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.

    PMID: 23784676BACKGROUND

  • 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.

    PMID: 27592364RESULT

  • 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.

    PMID: 29804483DERIVED

MeSH Terms

Conditions

Wound Infection

Interventions

Procalcitonin

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

CalcitoninPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsProtein PrecursorsProteins

Study Officials

  • Alev Atis, MD,ObGyn

    Kanuni Sultan Suleyman Training and Research Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,ObGYN

Study Record Dates

First Submitted

July 17, 2017

First Posted

July 21, 2017

Study Start

May 2, 2017

Primary Completion

September 29, 2017

Study Completion

October 8, 2017

Last Updated

October 24, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)