Intraoperative Disinfection by Pulse Irrigation With Povidone-Iodine Solution in Spine Surgery
NCT ID: NCT03249363
Last Updated: 2017-08-17
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
50 participants
Study Classification
INTERVENTIONAL
Study Start Date
2010-01-01
Study Completion Date
2012-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The purpose of this study was to evaluate the efficacy, in preventing Spinal Surgical Infection, of intraoperative pulsatile irrigation with a 2000-ml saline solution of PVP-Iodine in a group of patients undergoing complex spine surgery with a posterior approach. To confirm and better assess the efficacy of intraoperative irrigation on the infection rate in spinal surgery, specimens for bacterial culture were harvested by swabs from muscular tissue before and after irrigation of the wounds
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Remote Ischemic Preconditioning on Postoperative Complications in Visceral Surgery
NCT02375269
Postoperative Complication
UNKNOWN
NA
Transfusion Requirements During Spinal Surgery for Severe Scoliosis
NCT01490164
Scoliosis
COMPLETED
Del Nido Cardioplegia Randomized Trial
NCT02442050
Cardiac Perfusion
TERMINATED
NA
Postoperative Pressure Injury in Patients Undergoing Prone Spinal Surgery
NCT03965169
Pressure Injury
UNKNOWN
NA
Electric Polarization of Red Blood Cells : A Cohort Study to Assess the Erythrocytes Membrane Integrity Through Charge Conservation, Following Cardiac Surgery.
NCT05754294
Inflammatory Response
Erythrocyte Destruction
Red Blood Cell Disorder
+2 more
WITHDRAWN
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The investigators enrolled fifty patients undergoing spinal surgery were randomly divided in two subgroups (A and B) of 25 patients each. In subgroup A, wounds were irrigated with dilute (3%) povidone-iodine solution through a low-pressure pulsatile device. In subgroup B wounds were irrigated with normal saline solution thorough a bulb syringe. In both subgroup specimens for bacterial culture were harvested by swabs from surgical site before and after irrigation of the wounds.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Spinal Diseases
Spinal Fusion
Spine Injury
Infection, Hospital
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
PREVENTION
Blinding Strategy
SINGLE
Participants
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group A - Pulsed PVP-I Irrigation
Group in wich the patients who underwent spinal surgery were treated with 5-10 minutes of low-pressure irrigation with Povidone-Iodine (PVP-I) diluted to a 3% concentration (30g/l) in 2 l of saline performed before applying the bone graft
Group Type
EXPERIMENTAL
Group A - Pulsed PVP-I Irrigation
Intervention Type
PROCEDURE
Group B - Pulsed Saline Irrigation
Group in wich the patients who underwent spinal surgery were treated with 5-10 minutes of low-pressure irrigation with only 2 litres of saline solution (without povidone Iodine) performed before applying the bone graft
Group Type
ACTIVE_COMPARATOR
Group A - Pulsed PVP-I Irrigation
Intervention Type
PROCEDURE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Group A - Pulsed PVP-I Irrigation
Intervention Type
PROCEDURE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Male and Female
* Patients candidated to spinal surgery for spinal surgery
* Primary spinal surgery procedure
* Patients candidated to spinal surgery for spinal surgery
* Primary spinal surgery procedure
Exclusion Criteria
* Clinical signs of infection before surgery
* Previous spinal surgery
* Previous spinal surgery
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Rome Tor Vergata
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Gabriele Bernardi
MD
Responsibility Role
PRINCIPAL_INVESTIGATOR
References
Explore related publications, articles, or registry entries linked to this study.
Schuster JM, Rechtine G, Norvell DC, Dettori JR. The influence of perioperative risk factors and therapeutic interventions on infection rates after spine surgery: a systematic review. Spine (Phila Pa 1976). 2010 Apr 20;35(9 Suppl):S125-37. doi: 10.1097/BRS.0b013e3181d8342c.
Reference Type
BACKGROUND
National Nosocomial Infections Surveillance (NNIS) System Report, Data Summary from January 1992-June 2001, issued August 2001. Am J Infect Control. 2001 Dec;29(6):404-21. doi: 10.1067/mic.2001.119952. No abstract available.
Reference Type
BACKGROUND
Watters WC 3rd, Baisden J, Bono CM, Heggeness MH, Resnick DK, Shaffer WO, Toton JF; North American Spine Society. Antibiotic prophylaxis in spine surgery: an evidence-based clinical guideline for the use of prophylactic antibiotics in spine surgery. Spine J. 2009 Feb;9(2):142-6. doi: 10.1016/j.spinee.2008.05.008. Epub 2008 Jul 10.
Reference Type
BACKGROUND
Barker FG 2nd. Efficacy of prophylactic antibiotic therapy in spinal surgery: a meta-analysis. Neurosurgery. 2002 Aug;51(2):391-400; discussion 400-1.
Reference Type
BACKGROUND
Bratzler DW, Dellinger EP, Olsen KM, Perl TM, Auwaerter PG, Bolon MK, Fish DN, Napolitano LM, Sawyer RG, Slain D, Steinberg JP, Weinstein RA; American Society of Health-System Pharmacists; Infectious Disease Society of America; Surgical Infection Society; Society for Healthcare Epidemiology of America. Clinical practice guidelines for antimicrobial prophylaxis in surgery. Am J Health Syst Pharm. 2013 Feb 1;70(3):195-283. doi: 10.2146/ajhp120568. No abstract available.
Reference Type
BACKGROUND
Sansur CA, Smith JS, Coe JD, Glassman SD, Berven SH, Polly DW Jr, Perra JH, Boachie-Adjei O, Shaffrey CI. Scoliosis research society morbidity and mortality of adult scoliosis surgery. Spine (Phila Pa 1976). 2011 Apr 20;36(9):E593-7. doi: 10.1097/BRS.0b013e3182059bfd.
Reference Type
BACKGROUND
Tsirikos AI, Lipton G, Chang WN, Dabney KW, Miller F. Surgical correction of scoliosis in pediatric patients with cerebral palsy using the unit rod instrumentation. Spine (Phila Pa 1976). 2008 May 1;33(10):1133-40. doi: 10.1097/BRS.0b013e31816f63cf.
Reference Type
BACKGROUND
Sponseller PD, LaPorte DM, Hungerford MW, Eck K, Bridwell KH, Lenke LG. Deep wound infections after neuromuscular scoliosis surgery: a multicenter study of risk factors and treatment outcomes. Spine (Phila Pa 1976). 2000 Oct 1;25(19):2461-6. doi: 10.1097/00007632-200010010-00007.
Reference Type
BACKGROUND
Epstein NE. Do silver-impregnated dressings limit infections after lumbar laminectomy with instrumented fusion? Surg Neurol. 2007 Nov;68(5):483-5; discussion 485. doi: 10.1016/j.surneu.2007.05.045.
Reference Type
BACKGROUND
Lu M, Hansen EN. Hydrogen Peroxide Wound Irrigation in Orthopaedic Surgery. J Bone Jt Infect. 2017 Jan 1;2(1):3-9. doi: 10.7150/jbji.16690. eCollection 2017.
Reference Type
BACKGROUND
Gruenberg MF, Campaner GL, Sola CA, Ortolan EG. Ultraclean air for prevention of postoperative infection after posterior spinal fusion with instrumentation: a comparison between surgeries performed with and without a vertical exponential filtered air-flow system. Spine (Phila Pa 1976). 2004 Oct 15;29(20):2330-4. doi: 10.1097/01.brs.0000142436.14735.53.
Reference Type
BACKGROUND
Celik SE, Kara A. Does shaving the incision site increase the infection rate after spinal surgery? Spine (Phila Pa 1976). 2007 Jul 1;32(15):1575-7. doi: 10.1097/BRS.0b013e318074c39f.
Reference Type
BACKGROUND
Rogers DM, Blouin GS, O'Leary JP. Povidone-iodine wound irrigation and wound sepsis. Surg Gynecol Obstet. 1983 Nov;157(5):426-30.
Reference Type
BACKGROUND
Brandt C, Hott U, Sohr D, Daschner F, Gastmeier P, Ruden H. Operating room ventilation with laminar airflow shows no protective effect on the surgical site infection rate in orthopedic and abdominal surgery. Ann Surg. 2008 Nov;248(5):695-700. doi: 10.1097/SLA.0b013e31818b757d.
Reference Type
BACKGROUND
Viljanto J. Disinfection of surgical wounds without inhibition of normal wound healing. Arch Surg. 1980 Mar;115(3):253-6. doi: 10.1001/archsurg.1980.01380030009003.
Reference Type
BACKGROUND
Lineaweaver W, McMorris S, Soucy D, Howard R. Cellular and bacterial toxicities of topical antimicrobials. Plast Reconstr Surg. 1985 Mar;75(3):394-6. doi: 10.1097/00006534-198503000-00016.
Reference Type
BACKGROUND
Crowley DJ, Kanakaris NK, Giannoudis PV. Irrigation of the wounds in open fractures. J Bone Joint Surg Br. 2007 May;89(5):580-5. doi: 10.1302/0301-620X.89B5.19286.
Reference Type
BACKGROUND
Anglen JO. Wound irrigation in musculoskeletal injury. J Am Acad Orthop Surg. 2001 Jul-Aug;9(4):219-26. doi: 10.5435/00124635-200107000-00001.
Reference Type
BACKGROUND
Jarvis WR, Edwards JR, Culver DH, Hughes JM, Horan T, Emori TG, Banerjee S, Tolson J, Henderson T, Gaynes RP, et al. Nosocomial infection rates in adult and pediatric intensive care units in the United States. National Nosocomial Infections Surveillance System. Am J Med. 1991 Sep 16;91(3B):185S-191S. doi: 10.1016/0002-9343(91)90367-7.
Reference Type
BACKGROUND
Culver DH, Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG, Banerjee SN, Edwards JR, Tolson JS, Henderson TS, et al. Surgical wound infection rates by wound class, operative procedure, and patient risk index. National Nosocomial Infections Surveillance System. Am J Med. 1991 Sep 16;91(3B):152S-157S. doi: 10.1016/0002-9343(91)90361-z.
Reference Type
BACKGROUND
McGirt MJ, Parker SL, Lerner J, Engelhart L, Knight T, Wang MY. Comparative analysis of perioperative surgical site infection after minimally invasive versus open posterior/transforaminal lumbar interbody fusion: analysis of hospital billing and discharge data from 5170 patients. J Neurosurg Spine. 2011 Jun;14(6):771-8. doi: 10.3171/2011.1.SPINE10571. Epub 2011 Mar 18.
Reference Type
BACKGROUND
Kaye KS, Anderson DJ, Sloane R, Chen LF, Choi Y, Link K, Sexton DJ, Schmader KE. The effect of surgical site infection on older operative patients. J Am Geriatr Soc. 2009 Jan;57(1):46-54. doi: 10.1111/j.1532-5415.2008.02053.x.
Reference Type
BACKGROUND
Weber WP, Zwahlen M, Reck S, Feder-Mengus C, Misteli H, Rosenthal R, Brandenberger D, Oertli D, Widmer AF, Marti WR. Economic burden of surgical site infections at a European university hospital. Infect Control Hosp Epidemiol. 2008 Jul;29(7):623-9. doi: 10.1086/589331.
Reference Type
BACKGROUND
Calderone RR, Garland DE, Capen DA, Oster H. Cost of medical care for postoperative spinal infections. Orthop Clin North Am. 1996 Jan;27(1):171-82.
Reference Type
BACKGROUND
Goldenheim PD. In vitro efficacy of povidone-iodine solution and cream against methicillin-resistant Staphylococcus aureus. Postgrad Med J. 1993;69 Suppl 3:S62-5.
Reference Type
BACKGROUND
Block C, Robenshtok E, Simhon A, Shapiro M. Evaluation of chlorhexidine and povidone iodine activity against methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus faecalis using a surface test. J Hosp Infect. 2000 Oct;46(2):147-52. doi: 10.1053/jhin.2000.0805.
Reference Type
BACKGROUND
Perencevich EN, Sands KE, Cosgrove SE, Guadagnoli E, Meara E, Platt R. Health and economic impact of surgical site infections diagnosed after hospital discharge. Emerg Infect Dis. 2003 Feb;9(2):196-203. doi: 10.3201/eid0902.020232.
Reference Type
BACKGROUND
Hill RL, Casewell MW. The in-vitro activity of povidone-iodinecream against Staphylococcus aureus and its bioavailability in nasal secretions. J Hosp Infect. 2000 Jul;45(3):198-205. doi: 10.1053/jhin.2000.0733.
Reference Type
BACKGROUND
McLure AR, Gordon J. In-vitro evaluation of povidone-iodine and chlorhexidine against methicillin-resistant Staphylococcus aureus. J Hosp Infect. 1992 Aug;21(4):291-9. doi: 10.1016/0195-6701(92)90139-d.
Reference Type
BACKGROUND
van Meurs SJ, Gawlitta D, Heemstra KA, Poolman RW, Vogely HC, Kruyt MC. Selection of an optimal antiseptic solution for intraoperative irrigation: an in vitro study. J Bone Joint Surg Am. 2014 Feb 19;96(4):285-91. doi: 10.2106/JBJS.M.00313.
Reference Type
BACKGROUND
Kaysinger KK, Nicholson NC, Ramp WK, Kellam JF. Toxic effects of wound irrigation solutions on cultured tibiae and osteoblasts. J Orthop Trauma. 1995;9(4):303-11. doi: 10.1097/00005131-199509040-00006.
Reference Type
BACKGROUND
Bhandari M, Schemitsch EH, Adili A, Lachowski RJ, Shaughnessy SG. High and low pressure pulsatile lavage of contaminated tibial fractures: an in vitro study of bacterial adherence and bone damage. J Orthop Trauma. 1999 Nov;13(8):526-33. doi: 10.1097/00005131-199911000-00002.
Reference Type
BACKGROUND
Dirschl DR, Duff GP, Dahners LE, Edin M, Rahn BA, Miclau T. High pressure pulsatile lavage irrigation of intraarticular fractures: effects on fracture healing. J Orthop Trauma. 1998 Sep-Oct;12(7):460-3. doi: 10.1097/00005131-199809000-00005.
Reference Type
BACKGROUND
Flow Investigators. Fluid lavage of open wounds (FLOW): design and rationale for a large, multicenter collaborative 2 x 3 factorial trial of irrigating pressures and solutions in patients with open fractures. BMC Musculoskelet Disord. 2010 May 6;11:85. doi: 10.1186/1471-2474-11-85.
Reference Type
BACKGROUND
Abdul-Jabbar A, Berven SH, Hu SS, Chou D, Mummaneni PV, Takemoto S, Ames C, Deviren V, Tay B, Weinstein P, Burch S, Liu C. Surgical site infections in spine surgery: identification of microbiologic and surgical characteristics in 239 cases. Spine (Phila Pa 1976). 2013 Oct 15;38(22):E1425-31. doi: 10.1097/BRS.0b013e3182a42a68.
Reference Type
BACKGROUND
De Luna V, Mancini F, De Maio F, Bernardi G, Ippolito E, Caterini R. Intraoperative Disinfection by Pulse Irrigation with Povidone-Iodine Solution in Spine Surgery. Adv Orthop. 2017;2017:7218918. doi: 10.1155/2017/7218918. Epub 2017 Oct 2.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
URome
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Surgical Stress Measured by Microdialysis
NCT01495143
COMPLETED
NA
Intraoperative Cell Salvage and Postoperative Acidosis
NCT02800343
COMPLETED
Effect of Combined Remote Ischemic Preconditioning and Postconditioning on Acute Pulmonary Injury in Patients Undergoing Valvular Heart Surgery
NCT01427621
COMPLETED
PHASE4
Intraoperative Pauses in Relation to Stress Assessment Among Surgeons
NCT04626648
COMPLETED
NA
Pre-op Fluid Study
NCT05079269
ACTIVE_NOT_RECRUITING
NA
Inferior Venacava Ultrasound to Guide Fluid Management for Prevention of Hypotension After Spinal Anesthesia.
NCT04736498
COMPLETED
NA
Protection of the Heart With Remote Ischemic Preconditioning During Heart Surgery: A Pilot Study
NCT00546390
COMPLETED
NA
Brain Tissue Oxygen Saturation and Blood Transfusion in Cardiac Surgery
NCT00879463
COMPLETED
NA
Fluid Infusion During Breast Surgery
NCT00431743
UNKNOWN
PHASE4
Remote Ischaemic Preconditioning in Children Undergoing Cardiac Surgery
NCT01680601
COMPLETED
NA
Prevention or Treatment of Arterial Hypotension and Oxygen Cerebral Saturation During Major Abdominal Surgery
NCT05481047
COMPLETED
NA
Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients
NCT02342288
COMPLETED
NA
Internal Jugular Vein and Spinal-induced Hypotension
NCT05015218
COMPLETED
A Cohort Prospective Study of Predictors Influencing the Quality of Visualization of the Operating Field During Orthognathic Surgery
NCT05814991
ENROLLING_BY_INVITATION
Perioperative Cardiac Arrest and Outcome
NCT05316779
COMPLETED
Remote Ischemic Preconditioning During Cardiopulmonary Bypass
NCT03723993
WITHDRAWN
NA
Does Fluid Replacement From Preoperative NPO Status Improve Postoperative Recovery
NCT02638623
COMPLETED
NA
Association of the Arteriovenous Difference in Carbon Dioxide and Its Relation to the Difference in Arteriovenous Oxygen Content With the Occurrence of Postoperative Complication
NCT03914976
COMPLETED
Patient Management During Major Abdominal Surgery: an Oxygen Consumption Protocol Compared to Standard Approach
NCT03113435
RECRUITING
NA
Incidence , Risk Factors and Outcomes of Haemodynamic Instability and Cardiac Arrest During Spine Surgery
NCT05131854
UNKNOWN
Remote Ischemic Conditioning in Abdominal Surgery
NCT03234543
UNKNOWN
NA
Influence of Intraoperative Fluid Balance on the Incidence of Adverse Events in Pediatric Cardiac Surgery
NCT05142046
COMPLETED
Vasopressor Outcomes in Spine Surgery
NCT06053398
COMPLETED
EARLY_PHASE1
The Factors Associated 30-day Mortality After Perioperative Cardiac Arrest in Adults Undergoing Non-cardiac Surgery.
NCT06712134
COMPLETED
Remote Ischemic Preconditioning Before Abdominal Surgery
NCT01340742
WITHDRAWN
NA