Wound InfectionNCT03223233
Predicting the Severity of Post-cesarean Wound Infections Using Serum Procalcitonin Levels
An observational study of Wound Infection and Cesarean Wound Disruption, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Wound Infection, Cesarean Wound Disruption
- What is being tested?
- procalcitonin level
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2017to 8 Oct 2017
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: The participants are post-cesarean patients who developed surgical site infections.
Who may be able to join
- who developed surgical site infection after their cesarean sections.
- 18-40 years old
Who cannot join
- history of chorioamnionitis and premature rupture of membranes
- urinary tract infections
- any infectious condition other than surgical site infection
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Wound Infection, Cesarean Wound Disruption
- Being tested
- procalcitonin level
- Medical subject headings
- Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
procalcitonin levelOther
serum procalcitonin level will be measured in both groups.
| Study group | Role | What they receive |
|---|---|---|
| No secondary suture | The participants who developed post-cesarean surgical site infection and follow-up only antibiotic treatment for their wound care. Receives: Other: procalcitonin level | |
| Secondary suture | The participants who developed post-cesarean surgical site infection and need a secondary suture for their wound care Receives: Other: procalcitonin level |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start2 May 2017
- Primary completion29 Sep 2017
- Study completion8 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Wound InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital
- Investigators
- Alev Atis, MD,ObGyn, Study director, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223233
- Sponsor's protocol ID
- 2016/12.2
- Status last verified
- Oct 2017
- First submitted
- 17 Jul 2017
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 23375419Takakura 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 23784676Erenel 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 27592364Aslan 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting the Severity of Post-cesarean Wound Infections Using Serum Procalcitonin Levels
- ClinicalTrials.gov ID
- NCT03223233
- Acronym / sponsor ID
- 2016/12.2
- Conditions
- Wound Infection, Cesarean Wound Disruption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 2 May 2017 (actual)
- Primary completion
- 29 Sep 2017 (actual)
- Study completion
- 8 Oct 2017 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No secondary suture | – | Other: procalcitonin levelThe participants who developed post-cesarean surgical site infection and follow-up only antibiotic treatment for their wound care. |
| Secondary suture | – | Other: procalcitonin levelThe participants who developed post-cesarean surgical site infection and need a secondary suture for their wound care |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The participants are post-cesarean patients who developed surgical site infections.
Key inclusion criteria (2 listed)
- who developed surgical site infection after their cesarean sections.
- 18-40 years old
Key exclusion criteria (3 listed)
- history of chorioamnionitis and premature rupture of membranes
- urinary tract infections
- any infectious condition other than surgical site infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| procalcitonin levelserum procalcitonin level will be measured in both groups. | Other | No secondary suture, Secondary suture |
Primary outcome
Serum procalcitonin levels in participants who developed wound infection after cesarean sections
Time frame: 5 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2017.
- Background: PubMed 23375419Wacker 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.
- Background: PubMed 23784676Takakura 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.
- Results publication: PubMed 27592364Erenel 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.
- Derived from this study: PubMed 29804483Aslan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alev Atis, MD,ObGyn study director
Kanuni Sultan Suleyman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound Infection and Cesarean Wound Disruption, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum procalcitonin levels in participants who developed wound infection after cesarean sections (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03223233, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2017.