<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03249363</url>
  </required_header>
  <id_info>
    <org_study_id>URome</org_study_id>
    <nct_id>NCT03249363</nct_id>
  </id_info>
  <brief_title>Intraoperative Disinfection by Pulse Irrigation With Povidone-Iodine Solution in Spine Surgery</brief_title>
  <official_title>Intraoperative Disinfection by Pulse Irrigation With Povidone-Iodine Solution in Spine Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rome Tor Vergata</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Rome Tor Vergata</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to evaluate the efficacy, in preventing Spinal Surgical&#xD;
      Infection, of intraoperative pulsatile irrigation with a 2000-ml saline solution of&#xD;
      PVP-Iodine in a group of patients undergoing complex spine surgery with a posterior approach.&#xD;
      To confirm and better assess the efficacy of intraoperative irrigation on the infection rate&#xD;
      in spinal surgery, specimens for bacterial culture were harvested by swabs from muscular&#xD;
      tissue before and after irrigation of the wounds&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators enrolled fifty patients undergoing spinal surgery were randomly divided in&#xD;
      two subgroups (A and B) of 25 patients each. In subgroup A, wounds were irrigated with dilute&#xD;
      (3%) povidone-iodine solution through a low-pressure pulsatile device. In subgroup B wounds&#xD;
      were irrigated with normal saline solution thorough a bulb syringe. In both subgroup&#xD;
      specimens for bacterial culture were harvested by swabs from surgical site before and after&#xD;
      irrigation of the wounds.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2010</start_date>
  <completion_date type="Actual">January 1, 2012</completion_date>
  <primary_completion_date type="Actual">January 1, 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With surgical site infection</measure>
    <time_frame>From the surgery to 1 year after</time_frame>
    <description>Comparison of the results obtained from microbiological bacterial cultures of samples harvested during complex spine surgery in two groups of patients treated intraoperatively with pulsatile irrigation with diluted PVP-I (group A) or pulsatile irrigation with saline solution (group B)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Spinal Diseases</condition>
  <condition>Spinal Fusion</condition>
  <condition>Spine Injury</condition>
  <condition>Infection, Hospital</condition>
  <arm_group>
    <arm_group_label>Group A - Pulsed PVP-I Irrigation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B - Pulsed Saline Irrigation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Group A - Pulsed PVP-I Irrigation</intervention_name>
    <arm_group_label>Group A - Pulsed PVP-I Irrigation</arm_group_label>
    <arm_group_label>Group B - Pulsed Saline Irrigation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and Female&#xD;
&#xD;
          -  Patients candidated to spinal surgery for spinal surgery&#xD;
&#xD;
          -  Primary spinal surgery procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical signs of infection before surgery&#xD;
&#xD;
          -  Previous spinal surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <reference>
    <citation>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.</citation>
    <PMID>20407344</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>11743489</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>18619911</PMID>
  </reference>
  <reference>
    <citation>Barker FG 2nd. Efficacy of prophylactic antibiotic therapy in spinal surgery: a meta-analysis. Neurosurgery. 2002 Aug;51(2):391-400; discussion 400-1.</citation>
    <PMID>12182777</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23327981</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21325989</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>18449049</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>11013497</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17961738</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>28529858</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>15480149</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17621202</PMID>
  </reference>
  <reference>
    <citation>Rogers DM, Blouin GS, O'Leary JP. Povidone-iodine wound irrigation and wound sepsis. Surg Gynecol Obstet. 1983 Nov;157(5):426-30.</citation>
    <PMID>6635913</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>18948793</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>7356379</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>3975287</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>17540739</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>11476531</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>1928163</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>1656747</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>21417699</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19054183</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>18564917</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>8539047</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>8290460</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>11049709</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>12603990</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>10896798</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>1355784</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24553884</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>7562152</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>10714777</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>9781768</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>20459600</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>23873240</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 5, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>August 14, 2017</last_update_submitted>
  <last_update_submitted_qc>August 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rome Tor Vergata</investigator_affiliation>
    <investigator_full_name>Gabriele Bernardi</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Pulse Irrigation Povidone Iodine Spine Surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cross Infection</mesh_term>
    <mesh_term>Spinal Diseases</mesh_term>
    <mesh_term>Spinal Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03249363
org study id: URome
nct id: NCT03249363
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: Number of Participants With surgical site infection
time frame: From the surgery to 1 year after
description: Comparison of the results obtained from microbiological bacterial cultures of samples harvested during complex spine surgery in two groups of patients treated intraoperatively with pulsatile irrigation with diluted PVP-I (group A) or pulsatile irrigation with saline solution (group B)
arm group label: Group A - Pulsed PVP-I Irrigation
arm group type: Experimental
description: 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
arm group label: Group B - Pulsed Saline Irrigation
arm group type: Active Comparator
description: 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
intervention type: Procedure
intervention name: Group A - Pulsed PVP-I Irrigation
arm group label: Group A - Pulsed PVP-I Irrigation
arm group label: Group B - Pulsed Saline Irrigation
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
citation: 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.
PMID: 20407344
citation: 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.
PMID: 11743489
citation: 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.
PMID: 18619911
citation: Barker FG 2nd. Efficacy of prophylactic antibiotic therapy in spinal surgery: a meta-analysis. Neurosurgery. 2002 Aug;51(2):391-400; discussion 400-1.
PMID: 12182777
citation: 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.
PMID: 23327981
citation: 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.
PMID: 21325989
citation: 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.
PMID: 18449049
citation: 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.
PMID: 11013497
citation: 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.
PMID: 17961738
citation: 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.
PMID: 28529858
citation: 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.
PMID: 15480149
citation: 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.
PMID: 17621202
citation: Rogers DM, Blouin GS, O'Leary JP. Povidone-iodine wound irrigation and wound sepsis. Surg Gynecol Obstet. 1983 Nov;157(5):426-30.
PMID: 6635913
citation: 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.
PMID: 18948793
citation: 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.
PMID: 7356379
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PMID: 3975287
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responsible party type: Principal Investigator
investigator affiliation: University of Rome Tor Vergata
investigator full name: Gabriele Bernardi
investigator title: MD
mesh term: Cross Infection
mesh term: Spinal Diseases
mesh term: Spinal Injuries
sharing ipd: Undecided