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 is testing a special bandage that uses suction to help wounds heal faster in patients having spine surgery. The goal is to see if it can prevent infections and other problems better than regular bandages. The study will also find out which patients benefit the most from using this device.

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.

How does Prevena Therapy for Spine Surgery differ from other treatments?

Prevena Therapy for Spine Surgery is unique because it involves a specialized wound management system that helps reduce surgical site infections and improve healing, which is different from traditional methods that focus primarily on prehabilitation or postoperative care. ^{1 2 3 4 5}

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

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]

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]

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]

Citations

1. United States 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. [2023]

2. England 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. [2022]

3. France pubmed.ncbi.nlm.nih.gov

Nighttime bracing with the Providence thoracolumbosacral orthosis for treatment of adolescent idiopathic scoliosis: A retrospective consecutive clinical series. [2019]

4. Spain pubmed.ncbi.nlm.nih.gov

"Prehabilitation" in degenerative spine surgery: A literature review. [2021]

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

Prehabilitation for spine surgery: A scoping review. [2023]