The Use of Diluted Povidone Iodine Irrigation in Spine Surgery

Surgical Site Infection Clinical Trial

Official title:

The Use of Diluted Povidone Iodine Irrigation in Spine Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01577524
• Other study ID #: 2009-1350
• Status: Terminated
• Phase: Phase 2
• First received: March 30, 2012
• Last updated: July 13, 2016
• Start date: January 2012
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: Attabib, Najmedden, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Surgical Site Infection
• Surgical Wound Infection

Intervention

Drug:
• Povidone-Iodine
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.
• Saline
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.

Locations

Country	Name	City	State
Canada	Saint John Regional Hospital	Saint John	New Brunswick

Sponsors (1)

Lead Sponsor	Collaborator
Attabib, Najmedden, M.D.

Country where clinical trial is conducted

Canada, 

References & 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Schubert R. Disinfectant properties of new povidone-iodine preparations. J Hosp Infect. 1985 Mar;6 Suppl A:33-6. — View 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. — View 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. — View Citation

Wilson AP, Treasure T, Sturridge MF, Grüneberg 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No