protocolSection identificationModule nctId: NCT06284174, orgStudyIdInfo id: B-BR-109-054-T, briefTitle: Effectiveness of Povidone-Iodine Versus Chlorhexidine Gluconate Solutions in Reducing Microbial Contamination in Spinal Surgery Wounds During Intraoperative Soaking., statusModule overallStatus: RECRUITING, startDateStruct date: 2021-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: National Cheng-Kung University Hospital, class: OTHER, descriptionModule briefSummary: This study aims to assess the efficacy of intraoperative wound irrigation with iodine-containing and chlorhexidine-containing solutions in reducing bacterial colonization during spine surgery, and to determine which solution is more effective. Additionally, we aim to evaluate any side effects associated with the use of these two antiseptic solutions for wound irrigation., conditionsModule conditions: Spine Infection, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This research will include patients diagnosed with lumbar spinal stenosis causing nerve compression, who are scheduled for open spinal decompression and fusion surgery. Patients will be randomly assigned to one of three groups: a control group (soaked with 0.9% normal saline), an iodine group (soaked with 3.5% povidone-iodine solution), and a CHG group (soaked with 0.05% chlorhexidine gluconate). All groups will receive the same surgical pre-care, preoperative disinfection, and prophylactic antibiotics. Before wound closure, each group will undergo different irrigation solutions for soaking the wound for three minutes followed by rinsing with copious saline. Samples from deep and superficial tissues and implants will be taken for bacterial culture and molecular biochip analysis., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: Patients will be randomly assigned by computer to one of three groups: a control group (soaked with 0.9% normal saline), an iodine group (soaked with 3.5% povidone-iodine solution), and a CHG group (soaked with 0.05% chlorhexidine gluconate). All groups will receive the same surgical pre-care, preoperative disinfection, and prophylactic antibiotics.All patients understood the experimental process and signed the consent form. The patients did not know the group they were assigned to during the whole process. The bacterial culturers, examiners and clinical outcome assessors did not know the patient group., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 105, type: ESTIMATED, armsInterventionsModule interventions name: Povidone-iodine solution; chlorhexidine gluconate, outcomesModule primaryOutcomes measure: Bacteria culture and Polymerase chain reaction exam, secondaryOutcomes measure: Post operative infection, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Cheng Kung University Hospital, status: RECRUITING, city: Tainan, zip: 704, country: Taiwan, contacts name: Wei-Ren Su, M.D., M.Sc., role: CONTACT, phone: 886-6-2766689, email: suwr@ms28.hinet.net, geoPoint lat: 22.99083, lon: 120.21333, hasResults: False