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Spinal DiseasesNCT03249363

Intraoperative Disinfection by Pulse Irrigation With Povidone-Iodine Solution in Spine Surgery

A study testing Group A - Pulsed PVP-I Irrigation in people with Spinal Diseases and Spinal Fusion, run by University of Rome Tor Vergata.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Spinal Diseases, Spinal Fusion, Spine Injury
What is being tested?
Group A - Pulsed PVP-I Irrigation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
No sites listed yet
Study dates
1 Jan 2010to 1 Jan 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Male and Female
  • Patients candidated to spinal surgery for spinal surgery
  • Primary spinal surgery procedure

Who cannot join

  • Clinical signs of infection before surgery
  • Previous spinal surgery

About this study

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

Read the detailed description

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.

Being tested
Group A - Pulsed PVP-I Irrigation
Keywords
Pulse Irrigation Povidone Iodine Spine Surgery
Medical subject headings
Spinal Diseases, Spinal Injuries, Cross Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group A - Pulsed PVP-I IrrigationProcedure or surgery

Study groups in NCT03249363
Study groupRoleWhat they receive
Group A - Pulsed PVP-I IrrigationExperimentalGroup 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
Receives: Procedure: Group A - Pulsed PVP-I Irrigation
Group B - Pulsed Saline IrrigationActive comparatorGroup 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
Receives: Procedure: Group A - Pulsed PVP-I Irrigation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With surgical site infection

    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)

    Measured: From the surgery to 1 year after

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2017
  2. Study start1 Jan 2010
  3. Primary completion1 Jan 2012
  4. Study completion1 Jan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03249363
Sponsor's protocol ID
URome
Status last verified
Aug 2017
First submitted
5 Jul 2017
Last updated
17 Aug 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 20407344

  • 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.

    PubMed 11743489

  • 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.

    PubMed 18619911

  • Barker FG 2nd. Efficacy of prophylactic antibiotic therapy in spinal surgery: a meta-analysis. Neurosurgery. 2002 Aug;51(2):391-400; discussion 400-1.

    PubMed 12182777

  • 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.

    PubMed 23327981

  • 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.

    PubMed 21325989

  • 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.

    PubMed 18449049

  • 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.

    PubMed 11013497

  • 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.

    PubMed 17961738

  • 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.

    PubMed 28529858

  • 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.

    PubMed 15480149

  • 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.

    PubMed 17621202

  • Rogers DM, Blouin GS, O'Leary JP. Povidone-iodine wound irrigation and wound sepsis. Surg Gynecol Obstet. 1983 Nov;157(5):426-30.

    PubMed 6635913

  • 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.

    PubMed 18948793

  • 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.

    PubMed 7356379

Questions about this trial

What is this clinical trial studying?

A study testing Group A - Pulsed PVP-I Irrigation in people with Spinal Diseases and Spinal Fusion, run by University of Rome Tor Vergata.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With surgical site infection (time frame: From the surgery to 1 year after). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03249363, which also lists 36 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2017.

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