Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2025-12-24 @ 12:36 PM
Study NCT ID:
NCT05966961
Status:
RECRUITING
Last Update Posted:
2025-02-03
First Post:
2023-07-19
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010535', 'term': 'Laparoscopy'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2998}, 'targetDuration': '30 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2028-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2023-07-19', 'studyFirstSubmitQcDate': '2023-07-28', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of surgical site infection (superficial (A1) and deep (A2)', 'timeFrame': 'until 30 days + 5 days after surgery.', 'description': 'The aim of the study is to elucidate, if the colonization of bacteria is lower on the Novosyn® CHD suture compared to uncoated Polyglactin 910 suture, which will be assessed by the incidence of surgical site infections (SSI: A1 and A2).'}], 'secondaryOutcomes': [{'measure': 'Handling of the suture material', 'timeFrame': 'intraoperatively', 'description': 'Assessment of the handling of the suture material intraoperatively using a questionnaire including different dimensions (knot security, tensile strength, knot run down, tissue drag etc.) with 5 evaluations levels (excellent, very good, good, satisfied, poor).'}, {'measure': 'Length of hospital stay', 'timeFrame': 'until discharge (approximately 10 days after surgery)', 'description': 'Number of days the patient has to stay in hospital after emergency or elective laparotomy or laparoscopic surgery'}, {'measure': 'Time to return to work', 'timeFrame': 'until 30 days + 5 days after surgery.', 'description': 'Number of days the patient needed to return to work after emergency or elective laparotomy or laparoscopic surgery'}, {'measure': 'Incidence of Surgical Site Infection (SSI)', 'timeFrame': 'at discharge (approximately 10 days after surgery)', 'description': 'Incidence of Surgical Site Infection (SSI) (superficial (A1), deep (A2) and organ space (A3)) at the time of discharge'}, {'measure': 'Incidence of SSI (superficial (A1), deep (A2) and organ space (A3)) stratified by wound class', 'timeFrame': 'until 30 days + 5 days after surgery', 'description': 'Incidence of SSI (superficial (A1), deep (A2) and organ space (A3)) stratified by wound class (Class I clean, Class II clean/contaminated, Class III contaminated, Class IV dirty/infected)'}, {'measure': 'Cumulative Rate of postoperative complications', 'timeFrame': 'discharge (approximately 10 days after surgery) and 30 days+ 5 days after surgery.', 'description': 'Number of postoperative complications of any kind for descriptive analysis'}, {'measure': 'Cumulative Rate of reoperation', 'timeFrame': 'at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.', 'description': 'Number of reoperation of any kind for descriptive analysis'}, {'measure': 'Cumulative Rate of suture removal due to wound problems', 'timeFrame': 'at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.', 'description': 'Rate of suture removal due to wound problems (infection, dehiscence, residual material requiring removal) for descriptive analysis'}, {'measure': 'Cumulative Rate of Re-suturing', 'timeFrame': 'at discharge (approximately 10 days after surgery) and 30 days + 5 days after surgery.', 'description': 'Rate of Re-suturing of any kind for descriptive analysis'}, {'measure': 'Hernia rate', 'timeFrame': '30 days + 5 days postoperatively', 'description': 'Number of Wound Hernia including umbilical hernia verified by ultra-sound examination'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chlorhexidine coated suture', 'emergency laparoscopic surgery', 'emergency laparotomy surgery', 'elective laparoscopic surgery', 'elective laparotomy surgery', 'Novosyn®', 'Polyglactin 910'], 'conditions': ['Surgical Site Infection']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to elucidate, if the colonization of bacteria is lower on the Novosyn® CHD suture compared to uncoated Polyglactin 910 suture, which will be assessed by the incidence of surgical site infections (SSI: A1 and A2). The results of this registry will generate further clinical evidence for the use and the benefit of a Chlorhexidine coated suture used to close the wound after an emergency or elective laparoscopic or laparotomy surgery. The benefit for individual patients lies in the early diagnosis of complications and in the optimized postoperative controls of a clinical study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing wound closure after emergency or elective laparoscopic or laparotomy surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing an emergency or elective laparotomy or laparoscopic surgery.\n* Written informed consent\n* Age≥ 18 years\n* Not incapacitated patient\n\nExclusion Criteria:\n\n* No exclusion criteria except patients with allergy or hypersensitivity to chlorhexidine'}, 'identificationModule': {'nctId': 'NCT05966961', 'acronym': 'POLYNOVO-CHD', 'briefTitle': 'Novosyn® CHD vs Polyglactin 910 Suture to Close Wounds After Emergency or Elective Laparotomy or Laparoscopic Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aesculap AG'}, 'officialTitle': "'All Comer'/'Real-world' Registry-based Randomized, Prospective, Multicenter Clinical Trial to Evaluate the Incidence of Complications Using Novosyn® CHD Suture Versus Polyglactin 910 Suture to Close the Wound After Emergency or Elective Laparotomy or Laparoscopic Surgery", 'orgStudyIdInfo': {'id': 'AAG-G-H-2201'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Novosyn®', 'description': 'Sutures will be used to close the laparotomy or trocar incision in emergency or elective surgery. The suture material will be applied for fascia closure (and subcutaneous closure if applicable) in the context of daily clinical routine', 'interventionNames': ['Device: Novosyn® in emergency or elective laparotomy or laparoscopic surgery']}, {'label': 'Polyglactin 910', 'description': 'Sutures will be used to close the laparotomy or trocar incision in emergency or elective surgery. The suture material will be applied for fascia closure (and subcutaneous closure if applicable) in the context of daily clinical routine', 'interventionNames': ['Device: Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgery']}], 'interventions': [{'name': 'Novosyn® in emergency or elective laparotomy or laparoscopic surgery', 'type': 'DEVICE', 'description': 'Fascia closure (and subcutaneous closure if applicable) after emergency or elective laparotomy or laparoscopic surgery.', 'armGroupLabels': ['Novosyn®']}, {'name': 'Polyglactin 910 in emergency or elective laparotomy or laparoscopic surgery', 'type': 'DEVICE', 'description': 'Fascia closure (and subcutaneous closure if applicable) after emergency or elective laparotomy or laparoscopic surgery.', 'armGroupLabels': ['Polyglactin 910']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Francesco Stanzione, Dr.', 'role': 'CONTACT'}], 'facility': 'Pineta Grande Hospital', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Antonio José Torres Garcia, Dr.', 'role': 'CONTACT'}, {'name': 'Antonio José Torres Garcia, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Clínico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Santa Cruz de Tenerife', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Javier River Castellano, Dr.', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario de Canarias', 'geoPoint': {'lat': 28.46824, 'lon': -16.25462}}, {'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Javier Pardillo Ruiz, Dr.', 'role': 'CONTACT'}], 'facility': 'Hospital Universitario Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}], 'centralContacts': [{'name': 'Jaume Garcia Lopez', 'role': 'CONTACT', 'email': 'info@bbraun.com', 'phone': '+34935866200'}, {'name': 'Ricard Rosique', 'role': 'CONTACT', 'email': 'info@bbraun.com'}], 'overallOfficials': [{'name': 'Antonio José Torres Garcia, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital San Carlos, Madrid'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aesculap AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'B.Braun Surgical SA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}