Prevena Therapy for Spine Surgery

Overseen By Robert Galiano, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Northwestern University

Disqualifiers: Risk score <80, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

285 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of the Prevena Vacuum-Assisted Closure device in healing after spine surgery. The device is applied to the incision area to potentially accelerate recovery and reduce complications. Participants who recently underwent spine surgery and required a plastic surgeon for closure may be eligible. Some participants will use the Prevena device, while others will serve as a comparison group based on past surgeries without it. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, allowing researchers to understand its benefits for a broader range of patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What is the safety track record for Prevena Spine?

Research has shown that Prevena Therapy is generally safe for use in surgeries. Studies have found that this therapy can help reduce infections in surgical wounds. Although specific data for spine surgery is not yet available, it has been used successfully in other types of surgeries.

Safety information from other surgeries suggests that Prevena is well-tolerated. A study that combined results from multiple studies confirmed its safety and effectiveness. This indicates that, even though it is still under study for spine surgery, it has been used safely in similar situations.

Overall, Prevena Therapy has a history of safety in surgical settings, but further research will help confirm its safety specifically for spine surgery. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Prevena Therapy for spine surgery because it offers a unique approach to post-operative care. Unlike traditional wound care methods that rely on standard dressings, Prevena uses negative pressure wound therapy (NPWT) to help protect the incision site and promote healing. This technique can potentially reduce the risk of infection and complications by actively managing the wound environment, which is a significant advantage over conventional options. By targeting the incision area directly and maintaining optimal conditions for healing, Prevena might enhance recovery outcomes for patients undergoing spine surgery.

What evidence suggests that the Prevena device is effective for spine surgery?

Research shows that Prevena Therapy uses a gentle vacuum to aid wound healing after surgery. This method creates slight suction, reducing swelling and accelerating healing. Although few studies have focused on its use in spine surgery, similar methods have shown promise in other surgeries. In this trial, one group of participants will receive Prevena Therapy after spine surgery to evaluate its effectiveness for these patients. The therapy is already approved for other conditions, indicating its effectiveness in wound healing. However, more research is needed to confirm its efficacy specifically for spine surgery patients. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are having spine surgery and need a plastic surgeon to close the wound. They must have a risk score of 80 or above, indicating they're at higher risk for complications. Pregnant individuals, those with low-risk scores, or with conditions that could affect study results or compliance can't participate.

Inclusion Criteria

I am over 18 years old.

Risk Score Cutoff 80+

Matched to a prospective research participant

Exclusion Criteria

Risk Score Cutoff <80

Medical or psychiatric condition that may increase the risk with study participation, may complicate patient compliance, or may interfere with the interpretation of study results and, in the judgement of the Investigator, would make the subject inappropriate for entry into this study

Subjects who are pregnant at the date of surgery (SOC for surgery)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo spine surgery and receive either Prevena or conventional wound dressing

1 week

Follow-up

Participants are monitored for surgical site infections, wound dehiscence, seroma, skin necrosis, and readmission

1-6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Prevena Spine

Trial Overview The study is testing Prevena Vacuum-Assisted Closure devices on patients undergoing spine surgery. It's designed to see if this device helps in healing surgical wounds better than usual methods.

How Is the Trial Designed?

Group I: Group 2 (Prevena) Active Control 2 Interventions

Prospective group of patients receiving spine surgery who will have Prevena applied to incision area.

Group II: Group 1 (control) Placebo Group 1 Intervention

Retrospective control of patients who did not use Prevena following spine surgery.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

3M

Industry Sponsor

Trials

160

Recruited

31,600+

Dr. John Banovetz

3M

Chief Medical Officer since 2017

PhD in Inorganic Chemistry from Stanford University, Bachelor's degree in Chemistry from Hamline University

William 'Bill' Brown

3M

Chief Executive Officer

Bachelor's and Master's degrees in Mechanical Engineering from Villanova University, MBA from The Wharton School, University of Pennsylvania

Published Research Related to This Trial

Prehabilitation programs before spine surgery, which include education, exercise, and psychological strategies, are feasible and can improve postoperative outcomes such as pain, disability, and patient satisfaction, based on a review of 23 studies.

These programs may also help reduce medical costs, indicating a potential benefit for both patients and healthcare systems, although more research is needed to optimize these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation for spine surgery: A scoping review. Eubanks, JE., Carlesso, C., Sundaram, M., et al.[2023]

The Providence nighttime orthosis has a 57.1% success rate in preventing curve progression in adolescents with idiopathic scoliosis, based on a retrospective review of 56 patients over an average follow-up of 2.21 years.

Successful treatment is more likely in patients with a curve apex at T10 or lower and a Risser sign of 1 or higher, which can help identify ideal candidates for this orthotic treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nighttime bracing with the Providence thoracolumbosacral orthosis for treatment of adolescent idiopathic scoliosis: A retrospective consecutive clinical series. Davis, L., Murphy, JS., Shaw, KA., et al.[2019]

Prehabilitation, which includes physiotherapy and cognitive-behavioral therapy before surgery, may enhance postoperative outcomes for patients with lumbar degenerative pathology by improving physical condition and pain perception.

Factors such as obesity, co-morbidities, and negative perceptions about the condition can influence the effectiveness of prehabilitation, suggesting that addressing these issues is crucial for maximizing its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Prehabilitation" in degenerative spine surgery: A literature review. Delgado-López, PD., Rodríguez-Salazar, A., Castilla-Díez, JM.[2021]

A frail octogenarian who underwent multilevel lumbar spinal fusion surgery showed significant improvement in clinical and patient-reported outcomes after participating in a multimodal prehabilitation program that included physical exercise, nutritional support, and pain education.

The case report indicates that prehabilitation is a feasible and effective approach for optimizing the health of frail older adults before complex spine surgeries, potentially enhancing their recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Multimodal Prehabilitation on Patient-Reported Outcomes for a Frail Octogenarian Undergoing Multilevel Lumbar Spinal Fusion Surgery: A Case Report. Knudsen, R., Polifka, A., Markut, KA., et al.[2023]

The Preoperative Spinal Education (POSE) program significantly reduced the length of hospital stay (LOS) for spinal fusion surgery patients, with the Attend-POSE group having a median LOS of 3 days compared to 5 days for the pre-POSE group.

POSE was safe, as it did not increase complication or readmission rates, and helped patients feel better prepared and less anxious about their surgery, although only 43% of eligible patients chose to participate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Preoperative Spinal Education intervention for spinal fusion surgery designed using the Rehabilitation Treatment Specification System is safe and could reduce hospital length of stay, normalize expectations, and reduce anxiety : a prospective cohort study. Edwards, R., Gibson, J., Mungin-Jenkins, E., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39725287/

Negative Pressure Wound Therapy: An Analysis of Its ... Data included NPWT usage, type of surgery, infection rates, prior spinal surgeries, demographics, comorbidities, smoking status, and immune profiles.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03820219

Incisional Negative Pressure Wound Therapy in Patients ... To date, no studies have been done to establish the efficacy of the Prevena™ System for use on patients requiring spine surgery to reduce wound complications ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1878875024020412

Negative Pressure Wound Therapy: An Analysis of Its ... However, its efficacy in reducing wound infection rates after posterior thoracolumbar spine surgery remains uncertain. Methods. A retrospective review was ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05555355

NCT05555355 | Prevena Spine for Use in Spine Surgery A pilot, prospective, single-center study for the investigation of the use of Prevena Vacuum-Assisted Closure devices in patients undergoing spine surgery.

5. multimedia.3m.com multimedia.3m.com/mws/media/2217788O/3m-prevena-therapy-clinical-evidence-summary-orthopedicca-en.pdf

Clinical Evidence Orthopedics: TKA and THA ... outcomes related to Prevena Therapy. Individual results for each case may vary, depending on the patient, circumstances, and conditions. Incision Type Key.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9687616/

Negative Pressure Wound Therapy in Spinal Surgery - PMC The use of Prevena dressings also significantly reduced the incidence of SSI in patients with deep sternal wound infection that required muscle ...

7. solventum.com solventum.com/content/dam/public/language-masters/en/msb/document/2021/PREVENA-IMS-Spine-Brochure-US-70-2011-8263-4.pdf

36803-HCBSP-70-2011-8263-4 Prevena Spine Brochure. ... A systematic literature review and associated meta-analysis were used to support the safety and effectiveness of 3M™ Prevena™ Therapy over ...