Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-03-03 @ 12:08 PM
Study NCT ID:
NCT03223233
Status:
COMPLETED
Last Update Posted:
2017-10-24
First Post:
2017-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predicting the Severity of Post-cesarean Wound Infections Using Serum Procalcitonin Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014946', 'term': 'Wound Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077740', 'term': 'Procalcitonin'}], 'ancestors': [{'id': 'D002116', 'term': 'Calcitonin'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011498', 'term': 'Protein Precursors'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'targetDuration': '2 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-10-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-22', 'studyFirstSubmitDate': '2017-07-17', 'studyFirstSubmitQcDate': '2017-07-18', 'lastUpdatePostDateStruct': {'date': '2017-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum procalcitonin levels in participants who developed wound infection after cesarean sections', 'timeFrame': '5 months', 'description': "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"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Wound Infection', 'Cesarean Wound Disruption']}, 'referencesModule': {'references': [{'pmid': '23375419', 'type': 'BACKGROUND', '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.'}, {'pmid': '23784676', 'type': 'BACKGROUND', '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.'}, {'pmid': '27592364', 'type': 'RESULT', 'citation': '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': '29804483', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The participants are post-cesarean patients who developed surgical site infections.', 'genderDescription': 'Patients who underwent cesarean section', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* who developed surgical site infection after their cesarean sections.\n* 18-40 years old\n\nExclusion Criteria:\n\n* history of chorioamnionitis and premature rupture of membranes\n* urinary tract infections\n* any infectious condition other than surgical site infection'}, 'identificationModule': {'nctId': 'NCT03223233', 'briefTitle': 'Predicting the Severity of Post-cesarean Wound Infections Using Serum Procalcitonin Levels', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'Predicting the Severity of Post-cesarean Wound Infections Using Serum Procalcitonin Levels', 'orgStudyIdInfo': {'id': '2016/12.2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No secondary suture', 'description': 'The participants who developed post-cesarean surgical site infection and follow-up only antibiotic treatment for their wound care.', 'interventionNames': ['Other: procalcitonin level']}, {'label': 'Secondary suture', 'description': 'The participants who developed post-cesarean surgical site infection and need a secondary suture for their wound care', 'interventionNames': ['Other: procalcitonin level']}], 'interventions': [{'name': 'procalcitonin level', 'type': 'OTHER', 'description': 'serum procalcitonin level will be measured in both groups.', 'armGroupLabels': ['No secondary suture', 'Secondary suture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34303', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Kanuni SSRTH', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Alev Atis, MD,ObGyn', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD,ObGYN', 'investigatorFullName': 'Berna Aslan Cetin', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}