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

Trial Summary

What is the purpose of this trial?

Bacterial in the subdermal layer of the skin, such as in hair follicles and sweat glands, may contaminate surgical wounds. 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 fusion.

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 data supports the effectiveness of the treatment Povidone-Iodine for infection prevention in spinal fusion?

Research shows that using a diluted povidone-iodine solution during spinal surgeries can help reduce surgical site infections, which are common complications in these procedures. Additionally, povidone-iodine has been used effectively for disinfecting wounds in other types of surgeries, like heart surgery, indicating its broad antimicrobial properties. ^{1 2 3 4 5}

Is povidone-iodine safe for use in humans?

Povidone-iodine is generally safe for use in humans as a disinfectant, but it can occasionally cause skin irritation or allergic reactions. In heart surgery, it was used safely in many patients, though deep infections were serious despite its use. Its safety in spinal surgery is still being evaluated, as it may affect wound healing and bone union. ^{3 4 6 7 8}

How is the treatment Povidone-Iodine unique for preventing infections in spinal fusion surgeries?

Povidone-Iodine is unique because it is used as an antiseptic solution to disinfect surgical wounds during spinal fusion surgeries, potentially reducing infection rates. Unlike some other treatments, it is applied directly to the surgical site, and while it is a broad-spectrum disinfectant, its safety in spinal surgeries is still being evaluated due to occasional negative effects on wound healing and bone union. ^{1 2 3 7 9}

Eligibility Criteria

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

I am either male or female.

English Speaking

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

Exclusion Criteria

I have had surgery on my spine before.

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

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

References

1. Germany 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Prevention of Surgical Site Infection in Lumbar Instrumented Fusion Using a Sterile Povidone-Iodine Solution. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Can povidone-iodine solution be used safely in a spinal surgery? [2022]

4. England pubmed.ncbi.nlm.nih.gov

Ten years experience with povidone-iodine in heart surgery. [2019]

5. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Effect of short-time povidone-iodine application on osteoblast proliferation and differentiation. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of dermal toxicity and toxicokinetics of povidone‑iodine in Göttingen minipigs. [2023]

7. Italy 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. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the role of povidone‑iodine in the prevention of surgical site infections. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Povidone-iodine irrigation combined with Vancomycin powder lowers infection rates in pediatric deformity surgery. [2022]