The Use of Diluted Povidone Iodine Irrigation in Spine Surgery

NCT01577524 | Terminated Phase 2

• 1 other identifier: 2009-1350
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Site Infection

Outcome Measures

Primary Outcomes (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.

  Twelve months post operation

Study Arms (2)

Diluted Povidone Iodine Solution

ACTIVE COMPARATOR

Drug: Povidone-Iodine

Normal Saline Wash

PLACEBO COMPARATOR

Drug: Saline

Interventions

Povidone-Iodine DRUG

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.

Also known as: Betadine

Diluted Povidone Iodine Solution

Saline DRUG

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.

Normal Saline Wash

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Attabib, Najmedden, M.D.: lead

Study Sites (1)

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

Location

Related Publications (12)

• 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 BACKGROUND

• 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.

  PMID: 16094267 BACKGROUND

• 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.

  PMID: 2860178 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.

  PMID: 8290460 BACKGROUND

• 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.

  PMID: 1334988 BACKGROUND

• 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.

  PMID: 8300691 BACKGROUND

• 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.

  PMID: 2860173 BACKGROUND

• 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.

  PMID: 2860153 BACKGROUND

• 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.

  PMID: 2860156 BACKGROUND

• 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.

  PMID: 2868173 BACKGROUND

• 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.

  PMID: 15959380 BACKGROUND

• 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.

  PMID: 3558716 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Povidone-Iodine; Sodium Chloride

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Study Officials

• Najmedden Attabib, MD

  Neurosurgery Department, Saint John Regional Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDIV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 30, 2012
• First Posted: April 16, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: July 14, 2016

Record last verified: 2016-07

Locations

CA (1)