What side effects are associated with this type of intervention?

Negative pressure wound therapy (NPWT), such as the Prevena Vacuum-Assisted Closure devices, is commonly used to manage surgical incisions, promote healing, and reduce infection risk. Common side effects of NPWT include skin irritation, pain at the wound site, and potential allergic reactions to the adhesive dressings. In some cases, patients may experience bleeding, infection, or delayed wound healing. Device-related complications can include mechanical failure or issues with the vacuum seal, which may necessitate additional interventions. Overall, while NPWT is generally well-tolerated, monitoring for these side effects is essential to ensure optimal outcomes.

What prior FDA approvals exist?

The FDA has approved several treatments for managing surgical incisions, promoting healing, and reducing infection risk, similar to the Prevena Vacuum-Assisted Closure devices. Negative pressure wound therapy (NPWT) systems, such as the V.A.C. Therapy System by KCI, have been widely used and approved for these purposes. These devices create a controlled negative pressure environment to help draw wound edges together, remove exudate, and promote granulation tissue formation. Additionally, other NPWT devices like the PICO Single Use Negative Pressure Wound Therapy System have also received FDA approval, offering portable and disposable options for post-surgical wound care.

What other types of research exist?

Promising alternatives to Prevena Vacuum-Assisted Closure devices for surgical patients include: 1) Low-level laser therapy, which has shown efficacy in reducing inflammation and promoting tissue repair. 2) Hyperbaric oxygen therapy, which enhances oxygen delivery to tissues, promoting faster healing and reducing infection risk. 3) Advanced wound dressings with antimicrobial properties, such as those containing silver or honey, which help prevent infections and support healing. 4) Kinesio tape, which has been explored as a potential alternative to traditional bandaging in decongestive lymphatic therapy, aiding in fluid drainage and reducing swelling.

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Vacuum-Assisted Closure Device

Prevena Therapy for Spine Surgery

Phase 4

Recruiting

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-6 weeks following surgery

Awards & highlights

Drug Has Already Been Approved

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, vacuum-assisted closure devices like Prevena may cause skin irritation, discomfort at the application site, or allergic reactions to adhesive materials used.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-6 weeks following surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-6 weeks following surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-6 weeks following surgery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Seroma

Communicable Diseases

Frequency of Wound dehiscence

Secondary study objectives

Frequency of readmission

Frequency of skin necrosis

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Group 2 (Prevena)Active Control2 Interventions

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

Group II: Group 1 (control)Placebo Group1 Intervention

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Prevena Vacuum-Assisted Closure (VAC) device operates by applying negative pressure to surgical incisions, which helps to remove exudate and infectious materials from the wound site. This negative pressure promotes increased blood flow, reduces edema, and draws the edges of the wound together, thereby accelerating the healing process. For surgery patients, this is particularly important as it not only speeds up recovery but also significantly reduces the risk of postoperative infections, which can lead to complications and prolonged hospital stays.

The clinical efficacy and cost effectiveness of the vacuum-assisted closure technique in the management of acute and chronic wounds: a randomized controlled trial.