[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05011942":3,"trial-entities:NCT05011942":100,"trial-summary:NCT05011942":103},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":35,"secondary_outcomes":47,"sex":74,"minimum_age":75,"maximum_age":76,"healthy_volunteers":14,"eligibility_criteria":77,"std_ages":83,"locations":86,"central_contacts":96,"overall_officials":97,"references":98,"see_also_links":99},"NCT05011942","146827","Irrisept Spinal Fusion Pilot Study Protocol","ENROLLING_BY_INVITATION","2024-12","2024-09","2024-09-19","2022-06-06","University of Kansas Medical Center","OTHER",false,"Study objectives include assessing the use of Irrisept irrigation solution in lumbar spinal fusion procedures and effect on clinical and patient reported outcome measures. This includes assessing postoperative SSI as well as fusion rates in addition to patient reported outcome measures.","This is a randomized controlled pilot study with a study size of 50 patients. Results will be utilized to plan a larger scale study. Background literature supports the use of chlorhexidine gluconate as an irrigation solution to decrease SSI although this has not been conducted in this population of patients (lumbar spine fusion) to date. A decrease in SSI with Irrisept, could support the possible use of this as an irrigation solution to decrease infections postoperatively. It will be important to know the effect if any of Irrisept on fusion rates. This study will provide valuable information that may assist in future treatment and prevention of SSI in lumbar spinal fusion patients.",[18],"Lumbar Spine Disease",[],"INTERVENTIONAL","PREVENTION",[23],"NA",{"count":25,"type":26},50,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DEVICE","Irrisept Irrigation solution","ii. Irrigation (Irrisept vs control of normal saline) used after initial skin inicision prior to coming through fascia, after placement of instrumentation (screws, hooks), prior to placement of bone graft, and after fascial closure iii. Irrigation exposure\u002Fsoak time to be 1 min for each irrigation time point. iv. 1 bottle (450 mL) Irrisept irrigation to be used during case with normal saline rinse to follow at each irrigation time point in study subjects v. Normal saline irrigation will be used alone in control subjects at the same time points.",[33,34],"Irrisept irrigation solution","normal saline control arm",[36,40,43,45],{"measure":37,"description":38,"timeFrame":39},"Postoperative surgical site infections","Postop SSI","assessed for change at 1 month",{"measure":37,"description":41,"timeFrame":42},"postop SSI","assessed for change at 3 months",{"measure":37,"description":41,"timeFrame":44},"assessed for change at 6 months",{"measure":37,"description":41,"timeFrame":46},"assessed for change at 12 months",[48,52,53,54,55,58,60,62,64,66,67,68,69,71,72,73],{"measure":49,"description":50,"timeFrame":51},"Fusion rates after surgery","fusion rates after surgery with irrisept vs saline irrigation","assessed at 1 month",{"measure":49,"description":50,"timeFrame":42},{"measure":49,"description":50,"timeFrame":44},{"measure":49,"description":50,"timeFrame":46},{"measure":56,"description":57,"timeFrame":51},"Patient outcome measures","Visual Analog Score for pain measuring patient outcomes in both study arms",{"measure":56,"description":57,"timeFrame":59},"assessed at 3 months",{"measure":56,"description":57,"timeFrame":61},"assessed at 6 months",{"measure":56,"description":57,"timeFrame":63},"assessed at 12 months",{"measure":56,"description":65,"timeFrame":51},"Oswestry Disability Index Questionnaire measuring patient outcomes in both study arms",{"measure":56,"description":65,"timeFrame":59},{"measure":56,"description":65,"timeFrame":61},{"measure":56,"description":65,"timeFrame":63},{"measure":56,"description":70,"timeFrame":51},"Scoliosis Research Society (SRS) 22 Questionnaire measuring patient outcomes in both study arms",{"measure":56,"description":70,"timeFrame":59},{"measure":56,"description":70,"timeFrame":61},{"measure":56,"description":70,"timeFrame":63},"ALL","18 Years","85 Years",{"inclusion":78,"exclusion":80,"raw_text":82},[79],"Age 18-85, undergoing primary lumbar spinal fusion (less than or equal to 3 levels)",[81],"Prior lumbar fusion (decompression only okay), spinal infection, spinal neoplasm","Inclusion Criteria:\n\n* Age 18-85, undergoing primary lumbar spinal fusion (less than or equal to 3 levels)\n\nExclusion Criteria:\n\n* Prior lumbar fusion (decompression only okay), spinal infection, spinal neoplasm",[84,85],"ADULT","OLDER_ADULT",[87],{"facility":88,"city":89,"state":90,"zip":91,"country":92,"geoPoint":93},"The University of Kansas Medical Center","Kansas City","Kansas","66106","United States",{"lat":94,"lon":95},39.11417,-94.62746,[],[],[],[],{"nct_id":4,"conditions":101,"biomarkers":102},[18],[],{"nct_id":4,"found":104,"summary":105,"prompt_version":115},true,{"design":106,"status":107,"heading":108,"summary":109,"follow_up":110,"word_count":111,"commitments":112,"compensation":113,"drugs_mentioned":114},"This is a randomized controlled pilot study, meaning participants are randomly assigned to receive either Irrisept or normal saline. It plans to include 50 patients.","completed","Irrisept for Preventing Infection After Spinal Fusion","This study is testing if using Irrisept irrigation solution during lumbar spinal fusion surgery can help prevent infections. Lumbar spinal fusion is a surgery on your lower back. Researchers will compare Irrisept to a normal saline solution. You might be able to join if you are between 18 and 85 years old and are having your first lumbar spinal fusion surgery (up to 3 levels). You cannot join if you've had a previous lumbar fusion, a spinal infection, or spinal cancer. The main goal is to see if Irrisept reduces surgical site infections at 1, 3, and 6 months after surgery. The current status of this study is unclear, and it plans to enroll 50 patients.","Participants will be assessed for changes in postoperative surgical site infections at 1, 3, and 6 months after surgery.",116,"Not specified in the trial record.","Not stated in the trial record.",[30],"v2"]