September 29, 2021

Randomized controlled trial shows positive outcomes.

CLEANSING BLAST Povidone-iodine nasal irrigation and sprays are being evaluated for their efficacy at lowering or removing loads of SARS-CoV-2.

One lasting effect of COVID-19 has had researchers and providers searching for different ways to combat it. A recent study evaluated the ability of povidone-iodine to remove the COVID-19 virus located in the nasopharynx.

The randomized controlled trial, published in Indian Journal of Otolaryngology and Head & Neck Surgery, focused on 189 individuals between the ages of 15 and 90 years with RT-PCR-confirmed COVID-19 cases who were experiencing symptoms for the previous four days.

The trial consisted of seven branches of 27 patients each, with five intervention branches compared with two placebo comparator branches:

• Branch one received povidone-iodine nasal irrigation at a concentration of 0.4%.
• Branch two received povidone-iodine nasal irrigation at a concentration of 0.5%.
• Branch three received povidone-iodine nasal irrigation at a concentration of 0.6%.
• Branch four received povidone-iodine nasal spray at a concentration of 0.5%.
• Branch five received povidone-iodine nasal spray at a concentration of 0.6%.
• Branch six received distilled water through nasal irrigation.
• Branch seven received distilled water through nasal spray.

The authors observed a statistically significant proportion of nasopharyngeal clearance with all strengths of povidone-iodine nasal irrigation and nasal spray compared to the placebo. "Additionally, 0.5% nasal irrigation was significantly better than 0.5% nasal spray for viral clearance and had the highest nasopharyngeal clearance among all strengths," says ENT specialist Mostafa Kamal Arefin, one of the study's authors.

The only undesirable event was nasal irritation recorded in two patients each in the 0.4% and 0.6% povidone-iodine nasal irrigation groups. The authors ultimately recommend using povidone-iodine in the nasopharynx and oropharynx to prevent COVID-19.

Povidone-iodine is safe and effective, despite concerns of allergic reactions.

FOR EYES Povidone-iodine has a short application time and is unlikely to cause skin irritation.

Applying topical povidone-iodine to the ocular surface helps to prevent endophthalmitis during ophthalmic procedures, but some physicians hesitate to use the agent on patients with reported allergies to iodine. Recent research, however, suggests clinical situations that demand avoiding the use of povidone-iodine are rare, and that the benefits of using it far outweigh the risks.

Iodine-containing chemicals can provoke three types of allergic reactions: skin irritation, contact dermatitis and generalized anaphylaxis. Although patients might report allergies to iodine, iodinated contrast or shellfish, the study’s authors say true iodine allergies are rare and anaphylaxis after ophthalmic surgery has not been described in the literature.

The authors, publishing their results in Journal of VitreoRetinal Diseases, also note that even true allergies to the substances should not contraindicate the use of povidone-iodine for endophthalmitis prophylaxis. In fact, they say, avoiding povidone-iodine in patients who reported shellfish allergies or reactions to iodinated contrast unnecessarily increases the risk of endophthalmitis.

The authors say the benefits of using the prepping agent in ophthalmology include short application time for effectiveness, efficacy of dilute concentrations, lack of microbial resistance, ability to penetrate biofilm and safety to the retina. Skin irritation and contact dermatitis may occur if patients are exposed to the agent for a long period of time, but dangerous anaphylaxis has not been documented with povidone-iodine use, even for patients with a reported iodine allergy.

General surgery literature suggests that chlorhexidine may be an effective alternative. However, the hesitation to use chlorhexidine in ophthalmic settings stems from data showing it can cause corneal endothelial and epithelial toxicity. Additionally, allergic dermatitis is very common with chlorhexidine, but not with povidone-iodine.

"Omitting povidone-iodine use substantially increases the incidence of intraocular infection," conclude the authors. "Therefore, povidone-iodine continues to be the foundation of endophthalmitis prophylaxis in ophthalmology."

Proper control of S. aureus colonization prior to surgery is an important, sometimes overlooked step in reducing the SSI risk associated with S. aureus carriage in the nares.

Credit: 3M Company
Application of 3M^™ Skin and Nasal Antiseptic (Povidone-Iodine Solution 5% w/w [0.5% available iodine] USP) Patient Preoperative Skin Preparation to patient.

Credit: 3M Company
Kimberly Prinsen, RN MSN.

In the US alone, combined inpatient (10,303,000) and outpatient (11,474,800) surgeries account for approximately 22 million surgical procedures per year.¹ Each procedure can place a patient at risk for a surgical site infection (SSI). It is well documented that S. aureus is the most common cause of SSIs and is responsible for 30.4% of infections.¹ A substantial proportion of these (43.7%) are caused by methicillin-resistant S. aureus (MRSA).² Overall, S. aureus SSIs result in considerable morbidity and mortality,³ yet research indicates that up to 60% of SSIs are preventable.⁴

The importance of nasal decolonization to combat SSIs cannot be overstated and guidelines are evolving to include nasal decolonization as part of a comprehensive preoperative protocol to help reduce patients’ risk of SSI. In the 2019 update of the CDC Strategies to Prevent Hospital-onset Staphylococcus aureus Bloodstream Infections in Acute Care Facilities, surgical site infection (SSI) prevention practices were addressed. The guidance recommended as a core strategy that all patients undergoing high risk surgeries (e.g., cardiothoracic, orthopedic and neurosurgery), unless known to be S. aureus negative, use an intranasal antistaphylococcal antibiotic/antiseptic (e.g., mupirocin or iodophor) and chlorhexidine wash or wipes prior to surgery.

Facilities can choose to apply the selected pre-operative source control regimen universally to all patients versus screening for MRSA and treating. Recently, in alignment with the CDC guidance, universal nasal decolonization was included in the AORN Guidelines for Perioperative Practice: Patient Skin Antisepsis (May 2021). This focused attention on the need to decrease bacterial load, particularly S. aureus, especially in high-risk surgical procedures as more complex procedures, such as ortho and spine, move to the ambulatory setting. The guideline also focused on PVP-I as an alternative to an antibiotic (mupirocin).⁵

Keep in mind that high risk patients are not limited to cardiothoracic, orthopedic and neurosurgery, nor are they limited to inpatient surgery. In addition, there continues to be movement of more complex procedures being done in the ambulatory setting. For example, procedures that include implants increases risk for SSI and can occur in many specialties. Per the AORN guidance the need to include the decolonization as part of a preoperative protocols should be evaluated by an interdisciplinary team.⁵

Reducing SSI risk

The human body is a reservoir for S. aureus. Approximately 30% of healthy adults are carriers.^{3, 6, 7} In fact, S. aureus carriers are two to nine times as likely as non-carriers to develop SSIs, suggesting that the majority of infections are caused by a patient’s endogenous bacteria, including S. aureus.^8,9 The effective control of S. aureus colonization prior to surgery is an important, sometimes overlooked step in reducing the SSI risk associated with S. aureus carriage in the nares.

The anterior nare is recognized as an anatomical niche for S. aureus¹⁰ with its own unique bacterial ecosystem.11 Currently, the standard choice for nasal S. aureus decolonization prior to surgery is intra-nasal mupirocin (an antibiotic), applied twice-daily for 5 days prior to surgery.¹² A number of studies have shown intra-nasally applied mupirocin to reduce the proportion of procedures resulting in SSIs,^13,14 with one study reporting a reduction of 94% in patients undergoing gastrointestinal surgery.¹⁵ However, other randomized controlled trials have failed to show a significant reduction in infection rates.^16-18

Nasal S. aureus decolonization with mupirocin has drawbacks, including patient compliance due to the required twice-daily regimen over a five-day period as well as affordability. Another concern is increasing antibiotic resistance.¹⁹ These limitations have led to the exploration of alternatives for nasal decolonization.

Finding alternatives

3M^™ Skin and Nasal Antiseptic (Povidone-Iodine Solution 5% w/w [0.5% available iodine] USP) Patient Preoperative Skin Preparation, is cleared for preparation of the skin prior to surgery, as it helps reduce bacteria that potentially can cause skin infections. Safe for use in children as young as two months old (see 3M Drug Facts label), it has been available since 2010. The patented formula is specially designed for the unique nasal environment as a topical antiseptic approach to help reduce the risk factor of S. aureus that can lead to SSIs, providing an alternative to nasal decolonization with mupirocin.

This solution has been specifically formulated to reduce microbial load in the unique environment of the nares, and the efficacy of this particular preparation has been widely studied.20-24 The regimen involves a one-time application of 5% povidone-iodine solution to the anterior nares prior to a surgical procedure – and it reduces nasal S. aureus colonization for at least 12 hours.¹¹

Additionally, 3M^™ Skin and Nasal Antiseptic has been extensively researched and has more published peer-reviewed and investigator-initiated studies than any other nasal decolonization antiseptic product (as of July 2021) with more than 10 clinical studies. One study, in particular, focused on cost-effectiveness; A retrospective study conducted by Torres et al. (2016), in total knee and hip arthroplasty investigated the incidence of SSIs and cost-effectiveness of universal application of 3M^™ Skin and Nasal Antiseptic versus MRSA screening followed by treatment of carriers with mupirocin. The results showed 3M^™ Skin and Nasal Antiseptic was an effective alternative to mupirocin, resulting in significant cost savings and eliminated the risk of mupirocin resistance.

The ease of incorporating effective nasal decolonization into the preoperative protocol for every patient every time is an important consideration when selecting which method and product to use. 3M^™ Skin & Nasal Antiseptic is a one-time application done the hour* prior to surgery resulting in a 99.5% reduction in S. aureus.²⁵ Study results have demonstrated SSI risk reduction with the aid of this simple one-time preop application as part of a comprehensive preoperative SSI reduction bundle.^21,23,26

Reducing S. aureus in the nares can help reduce the risk of SSI when done as part of a comprehensive preoperative protocol. 3MTM Skin and Nasal Antiseptic is a simple solution to help address nasal colonization of S. aureus, and the clinical evidence is continuing to mount for this safe, time-saving and effective approach which can aid in the efficiency of preoperative patient preparation.

Note: To request a sample please click here.

*The clinical significance or in vitro data is unknown.

Note: Author Kimberly Prinsen, RN MSN, has over 36 years of experience as a nurse in the perioperative specialty. Kim holds a Bachelor of Science in Nursing from Allen College in Waterloo, IA and a Master of Science in Nursing Leadership from the same institution. Kim joined 3M in 2014. She is an Advanced Clinical Application Specialist with 3M Medical Solutions Division. Her current role focusses on antiseptics including nasal decolonization and perioperative skin preparation. Her work involves both product and program development. She has presented on HAI related topics throughout the United States and, in turn, created educational content for her colleagues to present globally. Prior to joining to 3M, Kim served as a Clinical Director of Surgical Services at a Hospital in Iowa and was responsible for overall operational and financial performance for Surgery, PACU, Ambulatory Unit, Sterile Processing, Ambulatory Surgery Center and Center for Pain Medicine. Kim also served as a Lieutenant in the Navy Reserves as part of the Fleet Hospital. She is a member of AORN and APIC.

Treating patients with povidone-iodine in pre-op is a proven way to prevent surgical site infections.

Patients who were scheduled to undergo cardiac and orthopedic procedures at the VA Portland Health Care System in Oregon were being screened for MRSA colonization. Carriers were prescribed a nasal decolonization regimen with mupirocin ointment one to four weeks before their procedures. Nevertheless, surgical site infection (SSI) rates among the patients began to rise. A team of nurses set out to find out why.

As it turned out, physicians and patients were having trouble complying with the protocol. Surgeons didn't always schedule screenings early enough to treat carriers before surgery, while patients who were prescribed mupirocin didn't always follow the application instructions, which involved self-administering the ointment twice a day for five days.

The team of nurses decided to address the issue by foregoing use of mupirocin. Instead, pre-op nurses now swab the nares of patients with povidone-iodine two hours before surgery. Application involves four swabs; each is used to windshield-wipe the vault and point of each nostril in 30-second sequences.

The new approach saw a higher compliance rate, and it cost only $14 per patient. It also worked. In the first year of implementation, no patients treated with povidone-iodine in pre-op developed an SSI.

"Would you rather self-administer nasal mupirocin twice a day for five days, or have a nurse administer [povidone-iodine] within two hours of surgery?" asks Melissa S. Schmidt, MSN, RN, CNL, CPAN, CAPA, PACU, clinical nurse leader at the Portland VA. "The outcomes are about the same. That’s why we’re no longer using the mupirocin protocol."

Its use shows promise as a preventative measure.

The coronavirus has taught us all how important it is to wear a mask to prevent infection, as it spreads via respiratory droplets, saliva or direct contact. One recent study highlights the rationale, safety, recommendations and dosage of povidone-iodine gargle as a useful method to decrease viral loads of COVID-19.

The study, published in Japanese Dental Science Review, notes that povidone-iodine is safe for use in oral and nasal cavities at concentrations up to 1.25%. It recommends nasal/oral administration of povidone-iodine every two to three hours up to four times a day for the following subjects:

• Patients who have confirmed/suspected SARS-CoV-2 infection; are undergoing high-risk procedures such as those involving nasal, oral, pharyngeal and pulmonary secretions; reside in COVID-19 hotspots; or are unconscious.
• Healthcare providers before and after patient contact and who are involved in the care of patients with suspected/confirmed SARS-CoV-2 infection; who are involved in high-risk procedures for patients in COVID-19 hotspots; or those lacking sufficient PPE.
• Patients and/or healthcare providers in COVID-19 hotspots involved in high-risk procedures involving asymptomatic patients.

While the practice of gargling and rinsing with undiluted povidone-iodine for at least 30 seconds is a standard regimen to prevent a sore throat, extended rinsing with an appropriate dilution of the antiseptic for more than two minutes up to four times a day is encouraged to reduce the incidence of airborne respiratory infections such as avian flu, SARS and swine flu, note the study's authors. The use of the gargle is recommended as a preventive strategy to effectively inactivate the viral load in the oral and oral pharyngeal region that can become infected with SARS- CoV-2.