~133 spots leftby Sep 2026

Irrigation Solution for Preventing Infections in Spinal Surgery

Palo Alto (17 mi)
Overseen byJared S. Fridley, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Jared Fridley
No Placebo Group
Approved in 1 jurisdiction

Trial Summary

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.
Is the Irrisept Irrigation System a promising treatment for preventing infections in spinal surgery?The Irrisept Irrigation System could be promising because it is designed to clean wounds during surgery, which can help prevent infections. Other studies show that using special solutions to wash wounds during surgery can lower infection rates, suggesting that similar treatments like Irrisept might also be effective.13578
What safety data exists for the Irrisept irrigation solution?The study titled 'The Effect of Different Irrigation Solutions on the Cytotoxicity and Recovery Potential of Human Osteoblast Cells In Vitro' investigates the cytotoxicity of Irrisept (chlorhexidine) on osteoblast cells, which is relevant to its safety profile. Additionally, the study 'Chlorhexidine Antiseptic Irrigation Eradicates Staphylococcus epidermidis From Biofilm: An In Vitro Study' examines the effectiveness of chlorhexidine, the active ingredient in Irrisept, in eradicating bacteria, which indirectly relates to its safety in preventing infections. However, specific safety data on the use of Irrisept in spinal surgery is not directly addressed in the provided research.23456
What data supports the idea that Irrigation Solution for Preventing Infections in Spinal Surgery is an effective treatment?The available research does not provide direct evidence supporting the effectiveness of the Irrigation Solution for Preventing Infections in Spinal Surgery specifically. However, it does mention the use of similar antiseptic solutions like chlorhexidine and povidone-iodine in other surgical contexts. For example, one study found that chlorhexidine can effectively eliminate certain bacteria in lab settings, which suggests it might help reduce infections. Another study discusses the use of povidone-iodine and Vancomycin powder in pediatric spinal surgeries, which showed a reduction in infection rates. While these findings are promising, they do not directly address the effectiveness of the Irrigation Solution in spinal surgery.34567
Do I have to stop taking my current medications for this trial?Yes, if you are currently taking antibiotics for any infection, you must stop, as concurrent antibiotic use is an exclusion criterion.

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

I am 18 years old or older.

Exclusion Criteria

Suspicion for osteomyelitis
I do not have any open wounds.
I am currently taking antibiotics for an infection.
I have had a spinal infection in the past.

Treatment Details

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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Irrisept IrrigationExperimental Treatment1 Intervention
Patients scheduled to undergo spinal instrumentation will receive intra-operative Irrisept irrigation.
Group II: Vancomycin-saline IrrigationActive Control1 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

Find a clinic near you

Research locations nearbySelect from list below to view details:
Rhode Island HospitalProvidence, RI
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Who is running the clinical trial?

Jared FridleyLead Sponsor
Rhode Island HospitalLead Sponsor

References

The use of closed-suction irrigation systems to manage spinal infections. [2010]Management of infection in the hardware system-fixated spine has proven to be problematic. In many cases, instrumentation is required to provide stability or to maintain correction of deformity, and removal could be hazardous. The authors describe the use of closed continuous irrigation to treat spinal wound infections in patients with fixation systems; irrigation can be used in all parts of the spine with excellent results.
Bacterial decontamination of surgical wounds treated with Lavasept. [2018]In a prospective randomized controlled double-blind study in 50 acutely injured patients, bacterially contaminated type 2-4 soft tissue wounds were treated with moist dressings of 0.2% Lavasept (fractionated polyhexamethylenbiguanide and macrogolum 4000) solution (n=28) in comparison with Ringer solution (n=22). Standardized swabs were taken on days 0, 2, 8 and 15 and investigated for microorganisms. For a quantitative evaluation, the number of colony forming units (CFU) was determined by a serial dilution technique. The tissue compatibility and anti-inflammatory effect were rated on a scale of 0 (=bad) to 3 (=very good). The most frequently found microorganism was Staphylococcus aureus, which was isolated from 13 wounds. Use of Lavasept led to a faster and significant reduction in microorganisms on the wound surfaces. The number of CFU per wound remained constant or decreased, in contrast to the wounds treated with Ringer solution. This was true for both Gram-positive and Gram-negative bacteria. There was no evidence of impaired wound healing in either group. The anti-inflammatory effect and the tissue compatibility of Lavasept were rated significantly better than that of Ringer solution. It is concluded that Lavasept combines antiseptic action with good tissue compatibility.
Chlorhexidine Antiseptic Irrigation Eradicates Staphylococcus epidermidis From Biofilm: An In Vitro Study. [2020]Antiseptic and antibacterial solutions used for intraoperative irrigation are intended to kill bacteria and thereby decrease the incidence of surgical site infections. It is unknown if the concentrations and exposure times of irrigation solutions commonly used for prophylaxis in clean cases (povidone-iodine 0.35% for 3 minutes) are effective against bacteria in biofilm that are present in implant infections. Currently, povidone-iodine (0.35%), chlorhexidine (0.05%), sodium hypochlorite (0.125%), and triple antibacterial solution are all being used off-label for wound irrigation after surgical débridement for orthopaedic infections.
The Effect of Different Irrigation Solutions on the Cytotoxicity and Recovery Potential of Human Osteoblast Cells In Vitro. [2022]Surgeons use various irrigation solutions to minimize the risk of prosthetic joint infection after total joint arthroplasty. The toxicity of these solutions is an important consideration in their use. This study investigates the effect of irrigation solutions Bacitracin, Clorpactin (sodium oxychlorosene), and Irrisept (chlorhexidine) on osteoblast cytotoxicity and proliferation.
Povidone-iodine irrigation combined with Vancomycin powder lowers infection rates in pediatric deformity surgery. [2022]Surgical site infection is a morbid, devastating complication after spinal procedures. Studies have investigated the effect of wound lavage with 3.5% Povidone-iodine solution or the use of intrawound Vancomycin powder. We examined the effect of Povidone-iodine irrigation, intrawound Vancomycin powder, or a combination of both agents in a tertiary care Pediatric Hospital.
What Is the Duration of Irrigation? An In Vitro Study of the Minimum Exposure Time to Eradicate Bacteria With Irrigation Solutions. [2022]Antiseptic irrigation solutions are commonly used by arthroplasty surgeons to reduce intraoperative bacterial colonization with the goal of reducing postoperative infections in the setting of primary total joint arthroplasty. Currently, the minimum irrigation time to eliminate common microbes implicated in periprosthetic joint infection is unknown. We sought to determine the minimum effective exposure time required to prevent growth of Staphylococcus aureus, Staphylococcus epidermidis, and Cutibacterium acnes with common antiseptic solutions.
Antiseptic Irrigation Solutions Used in Total Joint Arthroplasty: A Critical Analysis Review. [2023]There are limited data that directly compare the efficacy of antiseptic irrigation solutions used for the prevention and treatment of periprosthetic joint infections in orthopaedic procedures; there is a notable lack of prospective data.
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]Intraoperative wound irrigation (IOWI) is an important step in preventing surgical site infection (SSI). This study compared the effectiveness of saline with gentamicin versus povidine-iodine (PI) as IOWI solutions in preventing SSI in open spine surgery.