Nasal Decolonization for Orthopedic Trauma Patients

NCT04146116 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 201812801
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Many surgical site infections are caused by bacteria that is transferred from a patient's nose to their open surgical wound. Some small studies have shown that putting povidone-iodine in a patient's nose reduces this risk. This study aims to evaluate the real-world effectiveness of nasal povidone-iodine (PROFEND®) in a group of 50 patients at the University of Iowa.

Conditions

Surgical Site Infection

Keywords

nasal decolonization; Orthopedic trauma surgery

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Staphylococcus Aureus Nasal Colonization

  A dry, sterile, rayon swab will be used to sample the anterior apex portion of the right and left nostril. This swab will be tested for S. aureus bacteria. If bacteria are found in either nostril, the participant is categorized as being colonized with S. aureus (e.g. carries the bacteria in their nose with no signs or symptoms of infection).

  Within 6 hours after first dose of povidone-iodine

Secondary Outcomes (2)

• Number of Participants With Staphylococcus Aureus Nasal Colonization

  Within 24 hours after surgery

• Number of Participants With Surgical Site Infection

  Within 30 days of surgery

Study Arms (1)

Nasal povidone-iodine

EXPERIMENTAL

Intranasal povidone-iodine (PDI PROFEND) will be applied to the patients' noses before orthopedic trauma surgery and after surgery. This intranasal povidone-iodine was developed under the Tentative Final Monograph for Health-Care Antiseptic Drug Products 21 CFR Parts 333 and 369 (Docket # 75N-183H), Federal Register Volume 59, Number 116, Friday, June 17, 1994, Proposed Rules. However, the product need not be controlled like a pharmaceutical drug. The product may be stored and controlled similarly to an iodine or alcohol skin preparation product.

Drug: intranasal povidone-iodine

Interventions

intranasal povidone-iodine DRUG

povidone-iodine USP, 10% w/w antiseptic

Also known as: PROFEND

Nasal povidone-iodine

Eligibility Criteria

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

You may qualify if:

• Patients undergoing operative fixation of lower extremity fractures at the University of Iowa during the study period.

You may not qualify if:

• Patients unable to provide informed consent due to head trauma or dementia.

Sponsors & Collaborators

• University of Iowa: lead
• Professional Disposables International, Inc.: collaborator

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Marin Schweizer
• Organization: University of Wisconsin, Madison

mschweizer@medicine.wisc.edu

6082631545

Study Officials

• Marin L Schweizer, PhD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 50 patients will receive PROFEND intranasal povidone-iodine prior to surgery and after surgery. The study aims to evaluate the real-world effectiveness of PROFEND® in reducing S. aureus colonization and surgical site infections (SSIs).

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: October 31, 2019
• Study Start: February 19, 2020
• Primary Completion: June 8, 2021
• Study Completion: June 8, 2021
• Last Updated: June 28, 2023
• Results First Posted: June 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)