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The Use of Diluted Povidone Iodine Irrigation in Spine Surgery

Primary Purpose

Surgical Site Infection

Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Povidone-Iodine
Saline
Sponsored by
Attabib, Najmedden, M.D.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Site Infection

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Saint John Regional Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Diluted Povidone Iodine Solution

Normal Saline Wash

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 30, 2012
Last Updated
July 13, 2016
Sponsor
Attabib, Najmedden, M.D.
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1. Study Identification

Unique Protocol Identification Number
NCT01577524
Brief Title
The Use of Diluted Povidone Iodine Irrigation in Spine Surgery
Official Title
The Use of Diluted Povidone Iodine Irrigation in Spine Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why 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.
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Attabib, Najmedden, M.D.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Site Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diluted Povidone Iodine Solution
Arm Type
Active Comparator
Arm Title
Normal Saline Wash
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Povidone-Iodine
Other Intervention Name(s)
Betadine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of post-operative infections diagnosed in both treatment and control groups
Description
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.
Time Frame
Twelve months post operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Najmedden Attabib, MD
Organizational Affiliation
Neurosurgery Department, Saint John Regional Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17621202
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.
Results Reference
background
PubMed Identifier
16094267
Citation
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.
Results Reference
background
PubMed Identifier
2860178
Citation
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.
Results Reference
background
PubMed Identifier
8290460
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.
Results Reference
background
PubMed Identifier
1334988
Citation
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.
Results Reference
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PubMed Identifier
8300691
Citation
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.
Results Reference
background
PubMed Identifier
2860173
Citation
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.
Results Reference
background
PubMed Identifier
2860153
Citation
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.
Results Reference
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PubMed Identifier
2860156
Citation
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.
Results Reference
background
PubMed Identifier
2868173
Citation
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.
Results Reference
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PubMed Identifier
15959380
Citation
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.
Results Reference
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PubMed Identifier
3558716
Citation
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.
Results Reference
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The Use of Diluted Povidone Iodine Irrigation in Spine Surgery

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