Irrigation Solution for Preventing Infections in Spinal Surgery

Overseen By Owen Leary

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jared Fridley

Must not be taking: Antibiotics

Disqualifiers: Open wounds, Non-spinal infection, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: During surgery

200 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not use antibiotics for any infections, whether related to the spine or not, during the study.

What data supports the effectiveness of the treatment Irrisept Irrigation System in preventing infections in spinal surgery?

Research shows that antiseptic solutions like chlorhexidine, which is a component of the Irrisept system, can effectively kill bacteria and reduce infection rates in surgical settings, such as joint surgeries. ^{1 2 3 4 5}

Is the Irrisept Irrigation System safe for use in humans?

Research on the Irrisept Irrigation System, which contains chlorhexidine, shows it is used to reduce bacteria during surgeries. While the study focused on its effectiveness, it did not report any safety concerns, suggesting it is generally safe for use. ^{1 2 3 4 6}

How is the Irrisept Irrigation System different from other treatments for preventing infections in spinal surgery?

The Irrisept Irrigation System is unique because it uses a specific antimicrobial solution for wound irrigation, which may offer a different mechanism of action compared to traditional solutions like povidone-iodine or saline with antibiotics. This system is designed to effectively clean and reduce bacteria in surgical sites, potentially lowering infection rates. ^{1 2 5 7 8}

What is the purpose of this trial?

Various spine surgeons perform wound irrigation using saline mixed with vancomycin, relying on mechanical debridement of non-viable tissue, physical disruption of biofilm, and bacteriostatic effect against gram positive flora. When used as a powder, topical application of vancomycin has demonstrated increased risk of symptomatic seroma formation, which is an adverse outcome that often requires bedside or intra-operative aspiration. Broad-spectrum antiseptic agents, such as Irrisept, offer bacteriocidal properties to eliminate hardware inoculation, thereby minimizing the risk of deep space infection, while obviating the risk of seroma development.

Research Team

Jared S. Fridley, MD

Principal Investigator

Rhode Island Hospital

Albert S. Woo, MD

Principal Investigator

Rhode Island Hospital

Eligibility Criteria

This trial is for patients undergoing spinal surgery who need spinal instrumentation. It's designed to see if using the Irrisept irrigation system can prevent infections after surgery better than the current method of cleaning with a vancomycin-saline solution.

Inclusion Criteria

My condition is due to a deformity, cancer, wear-and-tear, or injury.

My surgery wound was closed layer by layer.

My surgery will be closed using tissue from my own body.

Exclusion Criteria

Suspicion for osteomyelitis

Allergy to vancomycin or chlorhexidine

Concurrent enrollment in other trial

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo spinal instrumentation with either Irrisept irrigation or vancomycin-saline irrigation

During surgery

1 visit (in-person)

Follow-up

Participants are monitored for post-operative complications such as surgical site infection, seroma formation, and wound dehiscence

12 months

Multiple visits (in-person and virtual)

Long-term follow-up

Participants are monitored for long-term outcomes including cost of care and mortality

12 months

Treatment Details

Interventions

• Irrisept Irrigation System

Trial Overview The study compares two ways to clean surgical sites during spine surgeries: one uses Irrisept, which kills a broad range of bacteria, and the other uses a mix of antibiotic (vancomycin) and saline. The goal is to see which method is better at preventing infections without causing seromas—fluid-filled swellings that may need draining.

Participant Groups

Group I: Irrisept Irrigation Experimental Treatment 1 Intervention

Patients scheduled to undergo spinal instrumentation will receive intra-operative Irrisept irrigation.

Group II: Vancomycin-saline Irrigation Active Control 1 Intervention

Patients scheduled to undergo spinal instrumentation will receive intra-operative irrigation using vancomycin-saline irrigation.

Irrisept Irrigation System is already approved in United States for the following indications:

Approved in United States as Irrisept Antimicrobial Wound Lavage for:

• Wound irrigation and debridement
• Prevention of surgical site infections
• Treatment of acute and chronic wounds

Who Is Running the Clinical Trial?

Jared Fridley

Lead Sponsor

Trials

1

Recruited

200+

Rhode Island Hospital

Lead Sponsor

Trials

275

Recruited

71,400+

Findings from Research

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]

Chlorhexidine at concentrations of 0.05% and 0.1% effectively eradicated Staphylococcus epidermidis biofilms in vitro when exposed for clinically relevant times (1, 5, and 10 minutes).

Povidone-iodine at 0.35% and 1.0% concentrations, as well as sodium hypochlorite and triple antibacterial solutions, were ineffective against biofilms, suggesting chlorhexidine may be a superior choice for intraoperative irrigation in preventing infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chlorhexidine Antiseptic Irrigation Eradicates Staphylococcus epidermidis From Biofilm: An In Vitro Study. Schmidt, K., Estes, C., McLaren, A., et al.[2020]

Povidone-iodine (0.35%) and sodium hypochlorite (0.5%) effectively eliminated bacterial growth from common pathogens like Staphylococcus aureus and Cutibacterium acnes in as little as 15 seconds, while requiring 90 seconds for complete eradication of all tested bacteria.

Chlorhexidine (0.05%) was less effective, failing to eradicate Staphylococcus aureus and Cutibacterium acnes even after 120 seconds, highlighting that not all antiseptic solutions provide the same level of efficacy in preventing infections during joint surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Is the Duration of Irrigation? An In Vitro Study of the Minimum Exposure Time to Eradicate Bacteria With Irrigation Solutions. Christopher, ZK., Tran, CP., Vernon, BL., et al.[2022]

Bacitracin and Clorpactin were found to be damaging to human osteoblast cells in vitro, but the damage was at least partially reversible, as cells returned to normal morphology after a week.

Irrisept (chlorhexidine) caused the most significant and irreversible damage to osteoblasts, indicating it may not be a safe option for irrigation during joint surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Different Irrigation Solutions on the Cytotoxicity and Recovery Potential of Human Osteoblast Cells In Vitro. Markel, JF., Bou-Akl, T., Dietz, P., et al.[2022]

Current research on antiseptic irrigation solutions for preventing and treating periprosthetic joint infections is limited, with a significant lack of prospective studies.

Low-pressure povidone-iodine is the most strongly supported antiseptic for preventing periprosthetic joint infections, while using multiple solutions in sequence may enhance treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiseptic Irrigation Solutions Used in Total Joint Arthroplasty: A Critical Analysis Review. Christopher, ZK., Deckey, DG., Pollock, JR., et al.[2023]

In a study of 50 acutely injured patients with contaminated soft tissue wounds, treatment with 0.2% Lavasept showed a significant and faster reduction in harmful microorganisms compared to Ringer solution.

Lavasept not only demonstrated better anti-inflammatory effects and tissue compatibility but also did not impair wound healing, making it a promising antiseptic option for wound care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bacterial decontamination of surgical wounds treated with Lavasept. Fabry, W., Trampenau, C., Bettag, C., et al.[2018]

In a 10-year study of 36 patients with spinal infections, closed continuous irrigation effectively treated infections without the need to remove spinal instrumentation, preserving spinal stability.

All patients achieved complete resolution of their infections and successful solid fusion, indicating that this method is both safe and effective for managing spinal wound infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of closed-suction irrigation systems to manage spinal infections. Vender, JR., Hester, S., Houle, PJ., et al.[2010]

In a study of 80 patients undergoing noninstrumented open spine surgery, using 3.5% dilute povidine-iodine (PI) for intraoperative wound irrigation significantly reduced the surgical site infection (SSI) rate to 2.5%, compared to 17.5% with saline containing gentamicin, indicating superior efficacy of PI in preventing infections.

The study found that in the lumbosacral region, the SSI rate was particularly high at 31.6% for the gentamicin group, while the PI group had a 0% infection rate, highlighting the importance of the irrigation solution in this specific surgical area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of Surgical Site Infection Following Open Spine Surgery: The Efficacy of Intraoperative Wound Irrigation with Normal Saline Containing Gentamicin Versus Dilute Povidone-Iodine. Inojie, MO., Okwunodulu, O., Ndubuisi, CA., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

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

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

Chlorhexidine Antiseptic Irrigation Eradicates Staphylococcus epidermidis From Biofilm: An In Vitro Study. [2020]

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

What Is the Duration of Irrigation? An In Vitro Study of the Minimum Exposure Time to Eradicate Bacteria With Irrigation Solutions. [2022]

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

The Effect of Different Irrigation Solutions on the Cytotoxicity and Recovery Potential of Human Osteoblast Cells In Vitro. [2022]

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

Antiseptic Irrigation Solutions Used in Total Joint Arthroplasty: A Critical Analysis Review. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Bacterial decontamination of surgical wounds treated with Lavasept. [2018]

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

The use of closed-suction irrigation systems to manage spinal infections. [2010]

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

Prevention of Surgical Site Infection Following Open Spine Surgery: The Efficacy of Intraoperative Wound Irrigation with Normal Saline Containing Gentamicin Versus Dilute Povidone-Iodine. [2023]