Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine Surgery

Surgical Site Infection Clinical Trial

Official title:

Bacterial Wound Contamination Prior to Closure: Povidone-Iodine Versus Saline Irrigation in Pediatric Spine Fusion Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02527512
• Other study ID #: IRB-P00015085
• Status: Completed
• Phase: Phase 4
• Start date: July 13, 2017
• Est. completion date: July 12, 2019

Study information

• Verified date: April 2021
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety of povidone-iodine irrigation in pediatric spinal patients by collecting pre- and post-operative safety labwork. Furthermore, the efficacy of povidone-iodine and normal saline irrigation at reducing bacterial contamination of the surgical wound will be measured by collecting cultures before and after irrigation.

Description:

Previous research has shown there is baseline bacterial contamination of surgical spinal wounds prior to closure. While this bacterial contamination may or may not lead to infection, recent adult studies demonstrated reduced infection rates by using povidone-iodine irrigation before closure. This study will determine the safety of using povidone-iodine irrigation in pediatric spinal patients and how effective it is at reducing bacterial contamination of the spinal surgical wound prior to closure, compared with normal saline. The investigators hypothesize povidone-iodine is both safe and effective. Understanding techniques that reduce the local bacterial load in the wound prior to closure after spinal fusion will give data to support measures that will ultimately reduce the rate of postoperative infections.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: July 12, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Age 3 to 18 years on day of surgery

2. diagnosis of spinal deformity

3. undergoing elective posterior spine multi-level instrumentation surgery

Exclusion Criteria:

1. Documented renal failure

2. documented allergy to iodine or shellfish

3. previous spine fusion surgery

4. undergoing elective posterior spine single-level instrumentation surgery

5. undergoing anterior spine multi-level instrumentation surgery

6. current antibiotic use.

Related Conditions & MeSH terms

• Surgical Site Infection
• Surgical Wound Infection

Intervention

Drug:
• Povidone-Iodine
Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine

Other:
• Normal Saline
Solution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter

Locations

Country	Name	City	State
United States	Children's Mercy Kansas City	Kansas City	Missouri
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (4)

Chang FY, Chang MC, Wang ST, Yu WK, Liu CL, Chen TH. Can povidone-iodine solution be used safely in a spinal surgery? Eur Spine J. 2006 Jun;15(6):1005-14. Epub 2005 Aug 20. — 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

Dietz FR, Koontz FP, Found EM, Marsh JL. The importance of positive bacterial cultures of specimens obtained during clean orthopaedic operations. J Bone Joint Surg Am. 1991 Sep;73(8):1200-7. — View Citation

Nandyala SV, Schwend RM. Prevalence of intraoperative tissue bacterial contamination in posterior pediatric spinal deformity surgery. Spine (Phila Pa 1976). 2013 Apr 15;38(8):E482-6. doi: 10.1097/BRS.0b013e3182893be1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Culture Positivity	Assess feasibility of a larger randomized controlled trial using significance of differences in the bacteriology and contamination rates of both treatment arms. Also measured baseline tissue colonization rates.	Cultures taken before and after irrigation during surgery
Secondary	Risk Groups	Baseline (pre-irrigation) and post-irrigation tissue colonization rates and changes in culture positivity	Cultures taken before and after irrigation during surgery