Povidone-Iodine for Infection Prevention in Spinal Fusion

Overseen By Lorena Floccari, MD

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Akron Children's Hospital

Disqualifiers: Prior spinal surgery, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day (surgery)

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if povidone-iodine, an antiseptic solution, can prevent infections in individuals with scoliosis undergoing spinal fusion surgery. It compares the effects of povidone-iodine with saline, a simple saltwater solution. Participants must be undergoing their first spinal fusion surgery on the middle or lower back. This study is crucial for minimizing infection risk post-surgery. As a Phase 4 trial, it involves an FDA-approved treatment and seeks to understand its benefits for more patients, contributing to broader medical knowledge.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for Povidone-Iodine?

Research has shown that povidone-iodine is safe and can help prevent infections during spinal surgery. Studies have found that using povidone-iodine in these surgeries reduces the risk of both surface and deeper infections without harming the spinal fusion.

Further research confirms its safety in surgeries for conditions like scoliosis. This treatment has been tested in various settings and is generally considered safe for preventing infections at the surgical site.

For those considering participation in a clinical trial involving povidone-iodine, evidence suggests it is a safe option for reducing infection risk during spinal surgeries. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using povidone-iodine for infection prevention in spinal fusion surgeries because it offers a potent antiseptic action that directly targets bacterial presence at the surgical site. Unlike traditional methods that may rely solely on sterile saline or other less potent antiseptics, povidone-iodine's iodine component provides a broad-spectrum antimicrobial effect, reducing the risk of post-surgical infections. This treatment is distinctive because it is applied topically and allows for a quick, three-minute drying time before surgical exposure, potentially streamlining the surgical preparation process while enhancing infection control.

What is the effectiveness track record for povidone-iodine in preventing infections in spinal fusion surgeries?

This trial will compare the effectiveness of povidone-iodine and saline in preventing infections during spinal fusion surgeries. Research has shown that povidone-iodine helps prevent infections during spinal surgeries. Studies have found that povidone-iodine can lower the risk of infections both on the surface and deeper in the surgical area. It is particularly effective in reducing infection rates in spinal fusion surgeries. This antiseptic solution kills bacteria and prevents them from causing infections at the surgical site. Evidence suggests it is a reliable choice for preventing infections in these procedures. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with scoliosis who are undergoing spinal fusion surgery. Participants should not have an allergy to iodine or povidone-iodine, and must not have a history of thyroid disease or other conditions that could interfere with the study.

Inclusion Criteria

English Speaking

I am either male or female.

I am having surgery to fuse my upper and/or lower spine.

Exclusion Criteria

I am having spine surgery that is not a primary posterior fusion of the thoracic or lumbar spine.

I have had surgery on my spine before.

I am not allergic to povidone-iodine, pregnant, or previously treated with radioiodine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo posterior spinal fusion with either 10% povidone-iodine or saline application to reduce bacterial contamination

1 day (surgery)

1 visit (in-person)

Postoperative Care

Routine postoperative care following standard of care procedures

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness, including incidence of bacterial growth and adverse events

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Povidone-Iodine

Trial Overview The study is testing whether applying 10% povidone-iodine solution subdermally can prevent infections better than saline (saltwater) in patients having spinal fusion surgery. Patients will be randomly assigned to one of these two treatments.

How Is the Trial Designed?

Group I: 10% Povidone-Iodine Arm Active Control 1 Intervention

A single-use sealed packet of three 10% povidone-iodine swabs will be opened via standard sterile technique. Three topical applications of 10% povidone-iodine along the length of the subdermis, using each of the 3 swab sticks provided from the sterile single-use packet. The solution will be allowed to dry at least three minutes. A culture will be obtained by rubbing an Eswab along the incision in the subdermis. Surgical exposure will proceed. After exposure is complete, an additional culture will be obtained with an Eswab in the deep wound. After corrective maneuvers are complete a final culture will be obtained with an Eswab just prior to wound closure.

Group II: Saline Arm Active Control 1 Intervention

Three sterile swabs will be provided for soaking in sterile saline. Three applications of sterile saline along the length of the subdermis, using each of the 3 swabs soaked in sterile saline. The solution will be allowed to dry at least three minutes. A culture will be obtained by rubbing and Eswab along the incision in the subdermis. Surgical exposure will proceed. After exposure is complete, and additional culture will be obtained with and Eswab in the deep wound. After corrective maneuvers are complete a final culture will be obtained with and Eswab just prior to wound closure.

Povidone-Iodine is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Betadine for:

• Antiseptic skin preparation
• Preoperative skin disinfection
• Wound care

Approved in United States as Betadine for:

• Preparation of skin prior to surgery
• Prevention of infection in minor cuts and scrapes
• Antiseptic skin preparation

Approved in Canada as PVP-I for:

• Antiseptic skin preparation
• Preoperative skin disinfection
• Wound care

Approved in Japan as Betadine for:

• Antiseptic skin preparation
• Preoperative skin disinfection
• Wound care

Who Is Running the Clinical Trial?

Akron Children's Hospital

Lead Sponsor

Trials

50

Recruited

5,009,000+

Published Research Related to This Trial

In a study of 475 pediatric patients undergoing spinal surgery, the combination of 3.5% Povidone-iodine irrigation and intrawound Vancomycin powder significantly reduced the surgical site infection (SSI) rate to 0.7%, compared to 10% in patients receiving no intervention.

The use of Vancomycin powder alone also showed a lower infection rate of 1.4%, indicating that both treatments are effective, but the combination offers the best protection against infections in non-neuromuscular patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Povidone-iodine irrigation combined with Vancomycin powder lowers infection rates in pediatric deformity surgery. Roberto, RF., Rowan, FA., Nallur, D., et al.[2022]

In a study of 7566 patients undergoing open-heart surgery, the use of 10% povidone-iodine (PVP-I) for skin and wound disinfection resulted in a low incidence of severe infections, with only 0.5% experiencing deep sternal or retrosternal infections.

While superficial wound healing defects occurred in 5% of patients and were easily treatable with local PVP-I application, deep infections posed a significant risk, leading to a 40% mortality rate, highlighting the importance of strict aseptic techniques and effective antibiotic use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ten years experience with povidone-iodine in heart surgery. Klövekorn, WP., Meisner, H., Sebening, F.[2019]

Povidone iodine (PVP-I) is widely used as a pre-operative antiseptic, but there are rare cases of allergic reactions, as demonstrated in two patients who developed allergic contact dermatitis after its use.

While PVP-I is generally considered a low sensitizer, this case highlights the need for further evaluation of its potential to cause allergic reactions, suggesting that pre-operative allergy testing for PVP-I may be worth considering in some patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An unusual complication of late onset allergic contact dermatitis to povidone iodine in oral & maxillofacial surgery - a report of 2 cases. Reyazulla, MA., Gopinath, AL., Vaibhav, N., et al.[2017]

Povidone-iodine (PVP-I) is effective in reducing surgical site infections (SSIs) when used at all stages of surgical intervention, including preoperative skin preparation, intraoperative irrigation, and postoperative wound management.

The review highlights the need for more rigorous clinical trials to compare PVP-I with other antiseptic agents, particularly for preoperative use, to better understand its advantages and potential economic benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the role of povidone‑iodine in the prevention of surgical site infections. Monstrey, SJ., Govaers, K., Lejuste, P., et al.[2023]

Short exposure to povidone-iodine (PVP-I) at concentrations of 1:10 and higher significantly decreased osteoblast viability and differentiation, but lower dilutions (1:1000) allowed for recovery in cell proliferation.

The presence of bone-morphogenetic protein-2 (BMP-2) helped restore alkaline phosphatase activity to near control levels, and even undiluted PVP-I showed increased mineral deposition, indicating potential for enhanced bone formation despite initial toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of short-time povidone-iodine application on osteoblast proliferation and differentiation. Schmidlin, PR., Imfeld, T., Sahrmann, P., et al.[2021]

A study on Göttingen Minipigs® showed that daily application of 7.5% and 10% povidone-iodine (PVP-I) for up to 39 weeks was safe, with no skin irritation or thyroid dysfunction observed.

Despite increased serum iodine levels, the treatment did not lead to endocrine disruption, suggesting that PVP-I could provide antimicrobial benefits in humans without significant safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of dermal toxicity and toxicokinetics of povidone‑iodine in Göttingen minipigs. Eddy, EP., Shet, MS., Cataldo, M., et al.[2023]

A study involving 244 patients undergoing spinal surgery found that using diluted povidone-iodine solution for wound irrigation significantly reduced the infection rate compared to normal saline, with no infections reported in the povidone-iodine group.

The use of diluted povidone-iodine did not negatively affect wound healing, bone fusion, or clinical outcomes, indicating it is a safe option for disinfection in spinal surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can povidone-iodine solution be used safely in a spinal surgery? Chang, FY., Chang, MC., Wang, ST., et al.[2022]

In a study comparing 460 spine surgeries in 2008 to 490 surgeries in 2009, the use of a povidone-iodine and hydrogen peroxide solution for irrigation resulted in a significant reduction of post-operative infections, with zero infections reported in 2009.

The findings suggest that the combination of PVP-I and H(2)O(2) is an effective method for enhancing surgical wound care and preventing infections in spine surgery patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of post-operative infections in spine surgery by wound irrigation with a solution of povidone-iodine and hydrogen peroxide. Ulivieri, S., Toninelli, S., Petrini, C., et al.[2022]

In a study of 278 patients undergoing elective posterior lumbar instrumentation, using a diluted sterile povidone-iodine (PVI) solution for wound irrigation significantly reduced the incidence of surgical site infections (SSIs) from 6.7% to 0.7%.

The use of PVI solution is particularly recommended for patients with higher body mass index and other risk factors for SSIs, as it demonstrated a relative risk reduction of 90.7% for infections compared to normal saline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of Surgical Site Infection in Lumbar Instrumented Fusion Using a Sterile Povidone-Iodine Solution. Carballo Cuello, CM., Fernández-de Thomas, RJ., De Jesus, O., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9210233/

Efficacy of Povidone Iodine Solution in the Prevention of ... In this study, we conclude that harvested autologous bone graft after PVI soaking in spinal fusion surgery can decrease the incidence of deep infection.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878875021006379

Prevention of Surgical Site Infection in Lumbar ... Some studies have documented that a diluted sterile povidone-iodine (PVI) solution can be safely used in posterior spinal fusion surgeries as an antiseptic.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40779037/

RCT-based meta-analysis of povidone-iodine irrigation in ... Conclusion: PI irrigation significantly lowers the risk of both superficial and deep SSIs in spinal surgery without negatively impacting fusion ...

4. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/2192568220975385

Efficacy of Povidone Iodine Solution in the Prevention of ... In this study, we conclude that harvested autologous bone graft after PVI soaking in spinal fusion surgery can decrease the incidence of deep infection.

5. eor.bioscientifica.com eor.bioscientifica.com/view/journals/eor/9/11/EOR-24-0091.xml

Does intraoperative wound irrigation with diluted povidone ... Moreover, patients who underwent IOWI with PI had lower rates of deep and superficial infections after spine surgery compared with the ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06744907/safety-and-efficacy-of-subdermal-betadine-during-posterior-spinal-fusion

Safety and Efficacy of Subdermal Betadine During ... The goal of this study is to learn about povidone-iodine and its ability to prevent infections specifically in patients with scoliosis receiving a spinal ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/12/NCT02527512/Prot_SAP_000.pdf

Povidone-iodine versus Saline Irrigation in Pediatric Spine ... A. Scientific Aims. The overall goal is to evaluate the safety and efficacy of surgical site irrigation with povidone-iodine in children and young.

8. ajicjournal.org ajicjournal.org/article/S0196-6553(24)00749-1/abstract

Spine surgical site infection outcome with preoperative ... Spine surgical site infection outcome with preoperative application of a presaturated 10% povidone-iodine nasal decolonization product in a 32- ...