Trial Outcomes & Findings for Nasal Decolonization for Orthopedic Trauma Patients (NCT NCT04146116)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

65 participants

Primary outcome timeframe

Within 6 hours after first dose of povidone-iodine

Results posted on

2023-06-28

Participant Flow

Obtained informed consent in the day of surgery area of the hospital prior to surgery.

Participant milestones

Participant milestones
Measure	Nasal Povidone-iodine 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. intranasal povidone-iodine: povidone-iodine USP, 10% w/w antiseptic
Overall Study STARTED	65
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Not collected.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Nasal Povidone-iodine n=51 Participants 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. intranasal povidone-iodine: povidone-iodine USP, 10% w/w antiseptic
Region of Enrollment United States	51 participants n=51 Participants

PRIMARY outcome

Timeframe: Within 6 hours after first dose of povidone-iodine

Population: All patients who received 2 doses of nasal povidone-iodine (pre-surgery and post-surgery)

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).

Outcome measures

Outcome measures
Measure	Nasal Povidone-iodine n=51 Participants 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. intranasal povidone-iodine: povidone-iodine USP, 10% w/w antiseptic
Number of Participants With Staphylococcus Aureus Nasal Colonization	12 Participants

SECONDARY outcome

Timeframe: Within 24 hours after surgery

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. 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).

Outcome measures

Outcome measures
Measure	Nasal Povidone-iodine n=51 Participants 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. intranasal povidone-iodine: povidone-iodine USP, 10% w/w antiseptic
Number of Participants With Staphylococcus Aureus Nasal Colonization	2 Participants

SECONDARY outcome

Timeframe: Within 30 days of surgery

Surgical site infection as defined by the Centers for Disease Control and Prevention National Healthcare Safety Network.

Outcome measures

Outcome measures
Measure	Nasal Povidone-iodine n=51 Participants 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. intranasal povidone-iodine: povidone-iodine USP, 10% w/w antiseptic
Number of Participants With Surgical Site Infection	0 Participants

Adverse Events

Nasal Povidone-iodine

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Nasal Povidone-iodine n=51 participants at risk 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. intranasal povidone-iodine: povidone-iodine USP, 10% w/w antiseptic
Product Issues Stinging in the Nose	5.9% 3/51 • Number of events 3 • Within 24 hours of initial application Collected via survey
Product Issues Burning sensation	2.0% 1/51 • Number of events 1 • Within 24 hours of initial application Collected via survey
Product Issues Sore Throat	2.0% 1/51 • Number of events 1 • Within 24 hours of initial application Collected via survey
Respiratory, thoracic and mediastinal disorders Cough	2.0% 1/51 • Number of events 1 • Within 24 hours of initial application Collected via survey

Additional Information

Dr. Marin Schweizer

University of Wisconsin, Madison

Phone: 6082631545

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place