AzTrials
AzTrials

Surgical Site InfectionPhase 2NCT01577524

The Use of Diluted Povidone Iodine Irrigation in Spine Surgery

A Phase 2 study testing Povidone-Iodine and Saline in people with Surgical Site Infection, run by Attabib, Najmedden, M.D. at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of the study is to determine whether diluted Povidone Iodine solution used to irrigate surgical wounds during spine surgery decreases the incidence of surgical site infections. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Surgical Site Infection
What is being tested?
Povidone-Iodine and Saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
58 participants
Where
1 siteCanada
Study dates
Jan 2012to Jun 2016
Phase
Phase 2
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age of 18-75
  • Undergoing posterior surgical spinal procedure for degenerative spine disease, extra-dural tumors, trauma, or spinal deformity
  • No obvious potential infective focus
  • Patient willing to enroll

Who cannot join

  • Age <18 or >75
  • Identified infective focus in the body, including furuncles,or acne at surgical incision site
  • Patient with discitis or spinal osteomyelitis
  • Dural tear
  • Potential use of Bone Morphogenic Protein (BMP)
  • Iodine hypersensitivity
Show all 10Show fewer
  • Out of province patients due to difficulty in arranging follow up visits
  • Minimal invasive spine surgical procedure (MISS) due to difficulty of having diluted Betadine solution contact soft tissue with the use if MISS retractors
  • Pregnancy
  • Inability to provide informed consent

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

Other trials in Canada

About this study

The purpose of the study is to determine whether diluted Povidone Iodine solution used to irrigate surgical wounds during spine surgery decreases the incidence of surgical site infections.

Read the detailed description

Post-operative infections in spine surgery have been extensively investigated in the literature. These investigations focus on the efficacy of using peri-operative antibiotics, Povidone Iodine skin preparations, the effects of shaving around the surgical sit, and the use of intra-operative diluted Povidone Iodine wound irrigation in preventing post-operative infections.

Povidone-iodine is a complex of polyvinyl pyrrolidine and tri-iodine ions widely used as an antiseptic agent. It has bactericidal activity against a wide spectrum of pathogens, including methicillin-resistant Staphylococcus aureus (MRSA). The safety of its use intra-operatively has been evaluated in animal studies and also supported through Randomized Controlled Trials in spinal surgery and in other surgical subspecialties.

The purpose of this study is to evaluate the efficacy of the intra-operative use of diluted Povidone Iodine solution in reducing post-operative infections when used for irrigating surgical incisions during spinal surgery compared with 0.9% Sodium Chloride Irrigation Solution (i.e. normal saline solution).

The primary outcome measure will be seen as a reduction in the number of post-operative infections. As a result and although not directly measured, it is suspected that a reduction in post-operative infections may result in quicker healing with fewer complications and pain.

Being tested
Povidone-Iodine, Saline
Medical subject headings
Surgical Wound Infection

What participants receive

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

  • Povidone-IodineDrug

    Also called Betadine

    Subjects in the treatment group will receive 3.5% diluted Povidone Iodine solution in the surgical incision in a quantity sufficient to fill the wound to the level of the skin. The Povidone Iodine solution will be maintained in the incision for 3 minutes, after which it will be flushed from the wound with normal saline solution.

  • SalineDrug

    Subjects in the Placebo Comparator group will receive normal saline solution in a quantity sufficient to fill the wound to the level of the skin. The saline solution will be maintained in the incision for 3 minutes, after which it will be flushed from the wound with additional saline solution to replicate the saline wash procedure followed in the Treatment group.

Study groups in NCT01577524
Study groupRoleWhat they receive
Diluted Povidone Iodine SolutionActive comparatorNot described
Receives: Drug: Povidone-Iodine
Normal Saline WashPlacebo comparatorNot described
Receives: Drug: Saline

What is being measured

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

  1. Number of post-operative infections diagnosed in both treatment and control groups

    The Centers for Disease Control (CDC)definition of surgical site infections (SSI)will be used for this study.This definition addresses both superficial and deep surgical site infections.

    Outcome will be determined by the number of superficial, deep, and total (superficial plus deep) wound infections for each group.

    Measured: Twelve months post operation

Timeline

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

  1. First posted16 Apr 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionJun 2016
  4. Study completionJun 2016

Why it stopped: We had very low recruitment rates that would have resulted in several years being added to the study to achieve an appropriate sample size.

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01577524
Sponsor's protocol ID
2009-1350
Status last verified
Jul 2016
First submitted
30 Mar 2012
Last updated
14 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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

  • Cheng MT, Chang MC, Wang ST, Yu WK, Liu CL, Chen TH. Efficacy of dilute betadine solution irrigation in the prevention of postoperative infection of spinal surgery. Spine (Phila Pa 1976). 2005 Aug 1;30(15):1689-93. doi: 10.1097/01.brs.0000171907.60775.85.

    PubMed 16094267

  • Georgiade G, Riefkohl R, Georgiade N, Georgiade R, Wildman MF. Efficacy of povidone-iodine in pre-operative skin preparation. J Hosp Infect. 1985 Mar;6 Suppl A:67-71. doi: 10.1016/s0195-6701(85)80048-7.

    PubMed 2860178

  • 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.

    PubMed 8290460

  • Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections. Infect Control Hosp Epidemiol. 1992 Oct;13(10):606-8. No abstract available.

    PubMed 1334988

  • Rubinstein E, Findler G, Amit P, Shaked I. Perioperative prophylactic cephazolin in spinal surgery. A double-blind placebo-controlled trial. J Bone Joint Surg Br. 1994 Jan;76(1):99-102.

    PubMed 8300691

  • Schubert R. Disinfectant properties of new povidone-iodine preparations. J Hosp Infect. 1985 Mar;6 Suppl A:33-6. doi: 10.1016/s0195-6701(85)80043-8.

    PubMed 2860173

  • Sindelar WF, Brower ST, Merkel AB, Takesue EI. Randomised trial of intraperitoneal irrigation with low molecular weight povidone-iodine solution to reduce intra-abdominal infectious complications. J Hosp Infect. 1985 Mar;6 Suppl A:103-14. doi: 10.1016/s0195-6701(85)80054-2.

    PubMed 2860153

  • Strohecker J, Piotrowski WP, Lametschwandtner A. The intra-operative application of povidone-iodine in neurosurgery. J Hosp Infect. 1985 Mar;6 Suppl A:123-5. doi: 10.1016/s0195-6701(85)80057-8.

    PubMed 2860156

  • Wilson AP, Treasure T, Sturridge MF, Gruneberg RN. A scoring method (ASEPSIS) for postoperative wound infections for use in clinical trials of antibiotic prophylaxis. Lancet. 1986 Feb 8;1(8476):311-3. doi: 10.1016/s0140-6736(86)90838-x.

    PubMed 2868173

  • Fang A, Hu SS, Endres N, Bradford DS. Risk factors for infection after spinal surgery. Spine (Phila Pa 1976). 2005 Jun 15;30(12):1460-5. doi: 10.1097/01.brs.0000166532.58227.4f.

    PubMed 15959380

  • Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.

    PubMed 3558716

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Povidone-Iodine and Saline in people with Surgical Site Infection, run by Attabib, Najmedden, M.D. at 1 site in Canada.

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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

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

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: We had very low recruitment rates that would have resulted in several years being added to the study to achieve an appropriate sample size.). Results are not available in the source record.

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 post-operative infections diagnosed in both treatment and control groups (time frame: Twelve months post operation). 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 NCT01577524, which also lists 12 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 14 Jul 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in