Ignite Creation Date:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2026-02-27 @ 5:09 PM
Study NCT ID:
NCT04055233
Status:
COMPLETED
Last Update Posted:
2019-08-13
First Post:
2018-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reduction of Postoperative Wound Infections by Antiseptica?
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': 'C031233', 'term': 'polihexanide'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two arm prospective randomized single center interventional trial. 1:1 randomization into experimental arm (irrigation with polyhexanide) and control arm (irrigation with saline).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 456}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-12', 'studyFirstSubmitDate': '2018-04-25', 'studyFirstSubmitQcDate': '2019-08-12', 'lastUpdatePostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'surgical site infection', 'timeFrame': '30 days postoperatively', 'description': 'Surgical site infection according to CDC definition.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgical Site Infection']}, 'referencesModule': {'references': [{'pmid': '35263172', 'type': 'DERIVED', 'citation': 'Strobel RM, Leistner R, Leonhardt M, Neumann K, Eschlbock SM, Lee LDG, Seifarth C, Schineis CHW, Kamphues C, Weixler B, Beyer K, Lauscher JC. Is There an Association between Intra-Operative Detection of Pathogens in Subcutaneous Tissue and Surgical Site Infections? Results from a Prospective Study. Surg Infect (Larchmt). 2022 May;23(4):372-379. doi: 10.1089/sur.2021.154. Epub 2022 Mar 9.'}, {'pmid': '31599810', 'type': 'DERIVED', 'citation': 'Strobel RM, Leonhardt M, Krochmann A, Neumann K, Speichinger F, Hartmann L, Lee LD, Beyer K, Daum S, Kreis ME, Lauscher JC. Reduction of Postoperative Wound Infections by Antiseptica (RECIPE)?: A Randomized Controlled Trial. Ann Surg. 2020 Jul;272(1):55-64. doi: 10.1097/SLA.0000000000003645.'}]}, 'descriptionModule': {'briefSummary': 'Wound infections are a frequent complication in abdominal surgery. The investigators hypothesize that the antiseptic solution 0.04 % polyhexanide (serasept) may reduce occurrence of postoperative wound infections compared to NaCL (saline) solution in a prospective randomized setting.', 'detailedDescription': 'Invstigator initiated monocenter randomized controlled trial. Intraoperative irrigation of subcutaneous tissue with NaCl (saline) solution or antiseptic solution 0.04 % polyhexanide (Serasept) in elective abdominal surgery. Primary endpoint: SSI 30 days postoperatively according to CDC criteria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: - planned laparotomy for visceral surgery\n\nExclusion Criteria:\n\n* Age under 18 years\n* allergy against polihexanid\n* laparoscopic surgery\n* emergency surgery\n* lack of understanding of the trial'}, 'identificationModule': {'nctId': 'NCT04055233', 'acronym': 'RECIPE', 'briefTitle': 'Reduction of Postoperative Wound Infections by Antiseptica?', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Reduction of Postoperative Wound Infections by Antiseptica?', 'orgStudyIdInfo': {'id': '2014-001551-22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Subcutaneous irrigation with 0.04% polyhexanide solution', 'description': 'Intervention: after closure of abdominal fascia, an intraoperative irrigation of the subcutaneous tissue with 250 ml antiseptic solution (0.04% polyhexanide) will be done once for ten minutes.\n\nNo subcutaneous suture. Closure of skin with either staples, interrupted sutures or running suture.', 'interventionNames': ['Drug: Polihexanide; Serasept']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Subcutaneous irrigation with NaCl (saline)', 'description': 'Intervention: after closure of fascia, an intraoperative irrigation of the subcutaneous tissue with 250 ml NaCl (saline) will be done once for one minute.\n\nNo subcutaneous suture. Closure of skin with either staples, interrupted sutures or running suture.', 'interventionNames': ['Drug: NaCl; saline']}], 'interventions': [{'name': 'Polihexanide; Serasept', 'type': 'DRUG', 'otherNames': ['Polihexanide (0.04% antiseptic solution)'], 'description': 'Experimental arm: irrigation of subcutaneous tissue after fascia closure with polihexanide (ten minutes).\n\nA single dose of perioperative antibiotics (cefuroxim alone or cefuroxim and metrodidazole in bowel surgeries) was given 30 minutes before skin incision.\n\nHair removal was done with electronic clippers and preoperative skin antisepsis was performed with propanol and povidone-iodine.\n\nBefore closure of fascia, instruments and gloves were changed. No subcutaneous suture was used. Skin was closed either with skin staples, continuous intracutaneous suture or interrupted suture.\n\nAll surgeries were done according to the Standard Operating Procedures of the Department for General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin.', 'armGroupLabels': ['Subcutaneous irrigation with 0.04% polyhexanide solution']}, {'name': 'NaCl; saline', 'type': 'DRUG', 'otherNames': ['NaCl (saline)'], 'description': 'Control arm: irrigation of subcutaneous tissue after fascia closure with NaCl (one minute) A single dose of perioperative antibiotics (cefuroxim alone or cefuroxim and metrodidazole in bowel surgeries) was given 30 minutes before skin incision.\n\nHair removal was done with electronic clippers and preoperative skin antisepsis was performed with propanol and povidone-iodine.\n\nAll surgeries were done according to the Standard Operating Procedures of the Department for General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin.\n\nBefore closure of fascia, instruments and gloves were changed. No subcutaneous suture was used. Skin was closed either with skin staples, continuous intracutaneous suture or interrupted suture.\n\nAll surgeries were done according to the Standard Operating Procedures of the Department for General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin.', 'armGroupLabels': ['Subcutaneous irrigation with NaCl (saline)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12200', 'city': 'Steglitz', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Charité Campus Benjamin Franklin', 'geoPoint': {'lat': 52.45606, 'lon': 13.332}}], 'overallOfficials': [{'name': 'Johannes C Lauscher, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité-University Medicine (Berlin, Germany)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johannes Lauscher', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, MD, PhD, Staff surgeon, Department of General, Visceral and Vascular Surgery', 'investigatorFullName': 'Johannes Lauscher', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}