Extended PREVENA Therapy for Post-Surgical Recovery

Not currently recruiting at 9 trial locations

Overseen By Eric Synatschk, MS, CCRP

Age: Any Age

Sex:

Trial Phase: Academic

Sponsor: KCI USA, Inc

Must not be taking: Opioids, Steroids, Chemotherapy, others

Disqualifiers: Pregnancy, Infection, Opioid use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Prevena Therapy, which aids in wound healing after surgery. Researchers aim to determine if it can improve recovery for surgeries on the legs, stomach, chest, or childbirth. Ideal candidates for this trial include individuals needing one of these surgeries who have risk factors such as being overweight, having diabetes, or a history of smoking. Participants must have a surgical wound expected to remain closed for more than 11 days and be willing to attend all follow-up visits. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of an effective treatment.

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

The trial information does not specify if you need to stop taking your current medications. However, if you are on medications that cause immune suppression, you may still be eligible to participate.

What prior data suggests that Prevena Therapy is safe for post-surgical recovery?

Research has shown that Prevena Therapy is generally well-tolerated by patients. One study found that patients who underwent joint replacement surgery and used Prevena Therapy were four times less likely to experience issues at the surgery site. This suggests the treatment can reduce the risk of post-surgery complications. Additionally, the Prevena Incision Management System was tested for safety in a large, carefully controlled study, confirming its safety. While no treatment is entirely risk-free, evidence supports Prevena Therapy as a safe option for post-surgery recovery. ^{1 2 3 4 5}

Why are researchers excited about this study treatment?

The PREVENA Therapy is unique because it offers a new approach to post-surgical recovery through its advanced incision management system. Unlike traditional wound care methods, such as standard dressings or sutures, PREVENA uses a negative pressure therapy system to keep the incision area clean and free from infection, which can significantly enhance healing. Researchers are excited about this treatment because it has the potential to reduce complications and improve recovery times for patients undergoing surgeries. By actively managing the wound environment, PREVENA stands out as a promising option to enhance surgical outcomes.

What evidence suggests that Prevena Therapy is effective for post-surgical recovery?

Research has shown that Prevena Therapy, which participants in this trial will receive, effectively manages surgical cuts. Studies have found that it reduces the risk of complications like infections and fluid buildup after surgeries, including knee and hip procedures. Prevena Therapy uses gentle suction to keep wounds clean and support healing. It has proven to be a safe and effective option for patients at risk of wound complications, especially after general surgeries. Overall, early evidence suggests that Prevena Therapy can significantly improve recovery after surgery. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 22 who can consent and return for follow-ups. It's for those having certain surgeries (orthopedic, abdominal, cardiac, or vascular) without infection risks but with factors like diabetes or smoking that could complicate healing. Pregnant women and chronic opioid users are excluded.

Inclusion Criteria

Subject can provide informed consent

I am 22 years old or older.

I need surgery in one of these areas: leg, abdomen/C-section, chest, or blood vessels.

Exclusion Criteria

I am a woman who is currently pregnant or breastfeeding, except if my surgery is a C-section.

I have been using opioids for more than 3 months.

Subject is enrolled in another interventional clinical study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PREVENA Therapy continuously for up to 14 days following surgery

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on surgical site complications

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Prevena Therapy

Trial Overview

The study tests the Prevena Plus Incision Management System with dressings to see if using it up to 14 days post-surgery is as safe and effective as the current approved use of up to 7 days. Patients will be monitored for their recovery progress over a period of up to 90 days.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 1 Intervention

Subjects undergoing 1 of 4 types of surgery will be enrolled and treated with the PREVENA Plus Incision Management System

Prevena Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Prevena Therapy for:

• Management of closed surgical incisions to reduce the incidence of seroma and superficial surgical site infections in high-risk patients with Class I and II wounds

Approved in European Union as Prevena Therapy for:

• Management of closed surgical incisions to reduce the incidence of seroma and superficial surgical site infections in high-risk patients with Class I and II wounds

Who Is Running the Clinical Trial?

KCI USA, Inc

Lead Sponsor

Trials

33

Recruited

6,100+

Solventum US LLC

Industry Sponsor

Trials

68

Recruited

10,600+

Bryan Hanson

Solventum US LLC

Chief Executive Officer since 2024

Bachelor's degree in Business Administration from Indiana University

Dr. Ryan Egeland

Solventum US LLC

Chief Medical Officer

MD, trained in Plastic and Reconstructive Surgery

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

The implementation of an Enhanced Recovery After Surgery (ERAS) program in colorectal surgery led to a significant reduction in postoperative hospital stay, with a median length of stay decreasing from 3 days in the pilot study to 6 days in the broader implementation phase, despite a drop in compliance from 93% to 74%.

The ERAS protocol was associated with a low readmission rate of 4% and no perioperative mortality in the pilot phase, indicating its safety and effectiveness in facilitating quicker recovery, although the overall complication rates increased during the broader implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introducing an enhanced recovery after surgery program in colorectal surgery: a single center experience. Bona, S., Molteni, M., Rosati, R., et al.[2018]

The study involved 444 patients undergoing elective colorectal surgery and found that the mobile application iColon improved adherence to Enhanced Recovery After Surgery (ERAS) items, with a 62.4% usage rate of the app and a 74.1% adherence to ERAS protocols.

Using iColon was associated with a significant reduction in 30-day readmission rates and received positive feedback from over 94% of users, indicating that digital health tools can enhance patient satisfaction and perceived quality of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

iColon, a patient-focused mobile application for perioperative care in colorectal surgery: Results from 444 patients. Bertocchi, E., Barugola, G., Masini, G., et al.[2023]

The success of outpatient parenteral antibiotic therapy (OPAT) relies heavily on measuring and analyzing patient outcomes to ensure quality improvement.

Collecting consistent and measurable data is crucial for transforming results into actionable insights that can enhance patient care in OPAT programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality assurance and outcomes in outpatient parenteral antibiotic therapy. Kunkel, MJ.[2019]

Outpatient parenteral antibiotic therapy (OPAT) is a cost-effective alternative to hospital care for intravenous antibiotic treatment, primarily due to savings in facility and staffing costs.

Successful OPAT programs require careful patient selection and alignment of interests among payers, physicians, and patients, while also ensuring quality assurance and outcome measurements to maintain treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacoeconomic considerations in the ambulatory use of parenteral cephalosporins. Tice, AD.[2018]

Enhanced Recovery After Surgery (ERAS) is a coordinated care approach that has been shown to improve clinical outcomes across various surgical procedures, supported by numerous randomized controlled trials and systematic reviews.

In addition to improving patient recovery, ERAS has also demonstrated significant economic benefits, making it a cost-effective strategy for perioperative care implemented globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Economic Benefits of Enhanced Recovery After Surgery. Huang, J.[2016]

The Enhanced Recovery After Surgery (ERAS) guidelines aim to minimize stress during surgery and promote quicker recovery, which can lead to shorter hospital stays and fewer complications.

Focusing on preadmission care as part of ERAS can significantly improve patients' physical condition after they leave the hospital.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ERAS in colorectal surgery - neglected preadmission items. Adamová, Z., Slováček, R., Romanová, G.[2020]

Outpatient parenteral antibiotic therapy (OPAT) provides an effective and safe alternative to in-hospital intravenous antibiotic treatment, allowing patients to receive care at home while maintaining similar health outcomes.

OPAT enhances patient satisfaction and quality of life by enabling individuals to continue their daily activities, while also reducing hospital stays, lowering costs, and minimizing the risk of hospital-acquired infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[New developments in outpatient parenteral antibiotic therapy (OPAT)]. Terhalle, E., Jung, N., Stegemann, MS., et al.[2021]

An animated visualization intervention significantly improved adherence to postoperative mobilization among 96 colorectal and gynecological oncology surgery patients, leading to a higher average daily step count compared to control participants.

Patients who received the animated intervention reported better perceived quality of recovery and found it easier to be mobile after surgery, suggesting that this approach could enhance recovery outcomes and should be considered for standard postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using animated visualization to improve postoperative mobilization: A randomized controlled trial. Jones, ASK., Kleinstäuber, M., Akroyd, A., et al.[2020]

In short-term treatments, administering intravenous antimicrobials at a hospital outpatient clinic (HO) was the most effective option, yielding 0.7239 QALYs, but it was also the most expensive at £973.

For long-term treatments, specialist nurse (SN) administration was the most effective (0.677 QALYs) despite being the costliest option at £2379, while self-administered (SA) treatment was the least expensive at £1883, indicating that SN and SA are both cost-effective strategies for outpatient antimicrobial therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of outpatient parenteral antibiotic therapy: a simulation modelling approach. Vargas-Palacios, A., Meads, DM., Twiddy, M., et al.[2021]

In a study of 107 pediatric patients with perforated appendicitis, treatment with ertapenem resulted in fewer postoperative infectious complications compared to a triple antibiotic therapy, with 2 complications in the ertapenem group versus 6 in the triple therapy group.

Ertapenem treatment also led to significantly lower rates of bowel colonization by resistant bacteria (11.3%) compared to the triple therapy group (35.2%), suggesting it may be a safer and more effective option for treating this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ertapenem versus standard triple antibiotic therapy for the treatment of perforated appendicitis in pediatric patients: a prospective randomized trial. Dalgic, N., Karadag, CA., Bayraktar, B., et al.[2018]

Citations

1.

multimedia.3m.com

multimedia.3m.com/mws/media/2009701O/3m-prevena-therapy-orthopedic-clinical-evidence-summary.pdf

Clinical Evidence Summary

The authors concluded that application of 3M™ Prevena™. Therapy on closed incisions after orthopedic surgery might help reduce the complications of a prolonged.

2.

solventum.com

solventum.com/content/dam/public/language-masters/en/msb/document/2023/msd-ssm-prevena-clinical-he-evidence-summary-general-en_gbl.pdf

Clinical Evidence Summaries General Surgery

Prevena Therapy was a safe and effective method of postsurgical management in general surgery patients considered to have risk of developing wound complications ...

3.

multimedia.3m.com

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

Clinical Evidence Orthopedics: TKA and THA

The 3M™ Prevena™ Incision Management System clinical evidence summaries presented adhere to the American Society of Plastic Surgeons (ASPS). Evidence Rating ...

4.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/reviews/DEN180013.pdf

De Novo Summary (DEN180013) Page 1 of 28 PREVENA ...

The purpose of the study was to assess the performance of. PREVENA Incision Management System versus conventional wound dressings on closed median sternal ...

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S2352344123000250

Closed Incision Negative Pressure Therapy vs Standard of ...

The use of ciNPT after TKA and THA was associated with a significant reduction in the risk of SSCs, including surgical site infections, seroma, dehiscence, and ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7949633/

News and views - PMC

Study concludes that total arthroplasty patients treated with PREVENA Therapy were 4 times less likely to experience surgical site complications compared with ...

7.

solventum.com

solventum.com/en-us/home/f/b5005265118/

3M™ Prevena™ Peel and Place Incision Management ...

Enhance your patients' postoperative recovery with the 3M™ Prevena™ Incision Management System ... Safety data sheets. Detailed product composition, safe handling ...