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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two solutions to prevent infections during spinal surgery. One group uses the Irrisept Irrigation System, a broad-spectrum antiseptic designed to kill bacteria and reduce infection risk without causing fluid build-up. The other group uses a saline solution mixed with vancomycin, an antibiotic that can help prevent infections but may lead to fluid-filled pockets (seromas). Suitable participants include those with spine deformities or injuries scheduled for spinal surgery without current infections. As an unphased trial, this study allows participants to contribute to innovative research that could enhance surgical outcomes for future patients.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Irrisept, a medical cleaning system, effectively cleans surgical areas using a solution with Chlorhexidine Gluconate (CHG), which combats many types of bacteria. This system often prevents infections during surgeries, including spine surgeries.

Studies have found that Irrisept is safe and generally well-tolerated by patients. Reports of serious side effects are rare, suggesting that most people do not experience major issues when it is used in surgeries.

For those considering joining the trial, knowing that Irrisept has been successfully used in various surgeries can be reassuring. However, always consult a healthcare provider about potential risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Irrisept Irrigation System because it offers a unique approach to preventing infections in spinal surgery. Unlike traditional methods that often rely on antibiotic solutions like vancomycin-saline, Irrisept uses a combination of chlorhexidine gluconate and surfactants to cleanse and disinfect the surgical site. This system is designed to more effectively reduce microbial presence during surgery, potentially lowering infection rates better than standard options. Additionally, its targeted delivery method could enhance surgical outcomes by ensuring thorough irrigation without relying solely on antibiotics, which helps in combating antibiotic resistance.

What evidence suggests that the Irrisept Irrigation System is effective for preventing infections in spinal surgery?

Research has shown that the Irrisept Irrigation System, containing chlorhexidine, effectively reduces bacteria during surgeries. This system uses a gentle wash to thoroughly clean the surgical area. Studies have found that this antiseptic solution helps prevent infections by killing many types of bacteria. In this trial, some participants will receive the Irrisept Irrigation System, while others will receive vancomycin-saline irrigation. Unlike vancomycin powder, which can cause fluid-filled pockets called seromas, Irrisept does not have this side effect. This makes it a potentially safer choice for patients undergoing spinal surgery. ^{1 2 3 4 5}

Who Is on the Research Team?

Jared S. Fridley, MD

Principal Investigator

Rhode Island Hospital

Albert S. Woo, MD

Principal Investigator

Rhode Island Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06439953

Irrisept Solution for Instrumented Spine Surgery The efficacy of intrawound vancomycin powder and povidone-iodine irrigation to prevent surgical site infections in complex instrumented spine surgery. Spine J.

2. irrisept.com irrisept.com/

Irrisept: Home Irrisept is a self-contained jet lavage delivering low-pressure irrigation. It contains Chlorhexidine Gluconate (CHG), a preservative, to offer broad spectrum ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9414142/

Irrigation techniques used in spine surgery for surgical site ... The most evidence exists for povidone-iodine and has Level 2 evidence supporting SSI reduction during spinal surgery.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11509154/

Assessing the Effects of Surgical Irrigation Solutions on ... This study examines an overlooked aspect of surgical irrigation solutions by investigating their impact on innate immunity and highlights the feasibility of ...

5. withpower.com withpower.com/trial/phase-postoperative-complications-5-2024-0943d

Irrigation Solution for Preventing Infections in Spinal Surgery Research on the Irrisept Irrigation System, which contains chlorhexidine, shows it is used to reduce bacteria during surgeries. While the study focused on its ...