Negative Pressure Wound Therapy for Knee and Hip Replacement

Recruiting at 12 trial locations

Overseen By Jennifer O'Connell, Sr. Clinical Project Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Molnlycke Health Care AB

Disqualifiers: Emergency surgery, Active infections, Allergies, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

105 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special wound therapy called Avance Solo Negative Pressure Wound Therapy for individuals undergoing a second knee or hip replacement. The goal is to determine if this therapy can reduce complications at the surgery site, particularly for high-risk patients. Participants must have a planned revision surgery on one knee or hip and no active infections. The trial seeks individuals who can understand and use the therapy system at home. As an unphased trial, it offers a unique opportunity to contribute to medical research and potentially benefit from advanced therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial investigators.

What prior data suggests that the Avance Solo Negative Pressure Wound Therapy is safe for knee and hip replacement surgeries?

Research has shown that Avance Solo Negative Pressure Wound Therapy (NPWT) is generally safe for patients. However, a small chance of blisters exists, particularly after knee replacement surgeries. This therapy uses a device that gently pulls on the wound to aid healing. Designed for use by one patient at a time, it remains effective even if the bandage becomes wet. Although NPWT is used in many surgeries, awareness of the blister risk is important. Overall, the treatment is well-tolerated, and most patients experience no major side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Avance Solo Negative Pressure Wound Therapy (NPWT) because it offers a new approach to healing wounds after knee and hip replacements. Unlike traditional wound care methods that typically involve dressings and topical treatments, NPWT uses a vacuum system to draw out fluid and increase blood flow to the area, which can speed up healing. This method can potentially reduce complications like infections and improve overall recovery times, making it a promising option for patients undergoing these common surgeries.

What evidence suggests that the Avance Solo Negative Pressure Wound Therapy is effective for surgical site complications in knee and hip replacements?

Research has shown that negative pressure wound therapy (NPWT) can aid in wound healing after hip and knee surgeries. In this trial, participants will use the Avance Solo system, a specific NPWT device that applies gentle suction to the wound to accelerate recovery and reduce complications. Studies have found that NPWT can ease movement and increase comfort, while also reducing pain during bandage changes. It promotes healing of surgical cuts without major safety concerns. Overall, NPWT effectively manages wounds after knee and hip replacements. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for high-risk patients who are undergoing a second (revision) knee or hip replacement surgery. It's not specified who can't join the trial, but typically, people with certain health conditions or those who don't meet the study requirements would be excluded.

Inclusion Criteria

High-risk patients for surgical wound complications as determined by investigators

Written informed consent

Patients must understand how to operate the negative pressure system at home

Exclusion Criteria

Subjects with contraindications as per the Avance Solo Instructions for use

Clinically significant conditions that would impair the subject's ability to comply with the study

Known allergies to product components (silicone adhesives, polyurethane films, acrylic adhesives, polyethylene fabrics, superabsorbent powders)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Treatment

Participants undergo revision of total hip or knee joint arthroplasty and receive closed incision negative pressure wound therapy

Immediate post-surgery period

Follow-up

Participants are monitored for surgical site complications and infections

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Avance Solo Negative Pressure Wound Therapy

Trial Overview

The study is testing whether using Avance Solo Negative Pressure Wound Therapy (NPWT) can reduce surgical site infections in patients having revision total knee or hip replacements.

How Is the Trial Designed?

Group I: Avance Solo ciNPT Experimental Treatment 1 Intervention

Avance Solo Negative Pressure Wound Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Avance Solo for:

• Closed surgical incisions
• Acute and chronic open wounds
• Pressure ulcers

Approved in European Union as Avance Solo for:

• Closed surgical incisions
• Acute and chronic open wounds
• Pressure ulcers

Who Is Running the Clinical Trial?

Molnlycke Health Care AB

Lead Sponsor

Trials

57

Recruited

7,900+

Published Research Related to This Trial

In a multicenter clinical trial involving 249 patients with high-risk lower extremity fractures, negative pressure wound therapy (NPWT) significantly reduced the incidence of infections compared to standard dressings, with 14 infections in the NPWT group versus 23 in the control group (P = 0.049).

The study found that patients treated with NPWT had a 1.9 times lower risk of developing infections, suggesting that NPWT is an effective prophylactic treatment for preventing complications in high-risk surgical incisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incisional negative pressure wound therapy after high-risk lower extremity fractures. Stannard, JP., Volgas, DA., McGwin, G., et al.[2022]

In a pilot study involving 60 patients undergoing major foot and ankle surgery, the use of a portable negative pressure wound therapy (NPWT) device resulted in a 7.5% rate of surgical site infections, which included both superficial and deep infections.

The incidence of surgical site infections with NPWT did not show a statistically significant reduction compared to a matched historical cohort, suggesting that while NPWT is feasible, it may not provide a clear advantage in preventing infections in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prophylactic negative pressure wound therapy after lower extremity fracture surgery: a pilot study. Dingemans, SA., Birnie, MFN., Backes, M., et al.[2019]

In a pilot study involving 70 patients undergoing elective hip arthroplasty, negative-pressure wound therapy (NPWT) showed a slight reduction in surgical site infection (SSI) rates compared to standard dressings, but the difference was not statistically significant (2 vs 3 infections).

However, patients using NPWT experienced a higher rate of postoperative wound complications, indicating that while NPWT may have some benefits, it could also lead to more issues, suggesting the need for a larger trial to better assess its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Negative-Pressure Wound Dressings to Prevent Surgical Site Complications After Primary Hip Arthroplasty: A Pilot RCT. Gillespie, BM., Rickard, CM., Thalib, L., et al.[2022]

In a study of 110 patients undergoing hip or knee revision surgery, negative pressure wound therapy (NPWT) showed a significantly lower ASEPSIS score (3.0) compared to standard dressing (5.1), indicating better wound healing outcomes in general.

While NPWT did not demonstrate a clinically relevant advantage for all patients, it was particularly beneficial for those with more than three risk factors for healing complications, showing a significant difference in ASEPSIS scores for this subgroup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative wound management with negative pressure wound therapy in knee and hip surgery: a randomised control trial. Giannini, S., Mazzotti, A., Luciani, D., et al.[2018]

Negative-pressure wound therapy (NPWT) is effective in promoting healing for various wound types and is increasingly used in homecare settings due to portable devices, allowing for earlier patient discharge from hospitals.

The Avance Solo system, a single-patient-use NPWT device, enhances patient mobility and comfort while minimizing pain during dressing changes, demonstrating its potential to improve quality of life during multi-week treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A portable, disposable system for negative-pressure wound therapy. Brandon, T.[2015]

In a study involving 11 patients with knee prosthesis infections, negative-pressure wound therapy effectively promoted healing by increasing blood flow and granulation tissue formation, which helped in managing septic complications.

The use of negative-pressure therapy allowed most patients to retain their knee implants, highlighting its potential as a valuable treatment option in orthopedic surgery for infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative Pressure, a "Solution" in the Treatment of Infected Knee Prosthesis? Ene, R., Panti, Z., Albu, E., et al.[2022]

Negative pressure wound therapy (NPWT) shows a significant benefit over standard wound therapy (SWT) for wound closure in patients healing by secondary intention, based on a meta-analysis of 48 studies involving 4315 patients.

NPWT also significantly reduces the length of hospital stays by nearly 5 days compared to SWT, although no differences were found for other outcomes like mortality or adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative pressure wound therapy in patients with wounds healing by secondary intention: a systematic review and meta-analysis of randomised controlled trials. Zens, Y., Barth, M., Bucher, HC., et al.[2021]

Negative pressure wound therapy (NPWT) was found to reduce the incidence of superficial surgical site infections in patients undergoing total hip and knee arthroplasty, based on a meta-analysis of six randomized controlled trials.

However, patients receiving NPWT after total knee arthroplasty experienced a higher occurrence of blisters, indicating a potential side effect of this treatment method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Negative pressure wound therapy in total hip and knee arthroplasty: a meta-analysis. Wang, L., Xu, X., Cao, JG., et al.[2020]

Citations

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molnlycke.us/products-solutions/avance-solo/

Avance Solo | Mölnlycke

Avance Solo NPWT system continues to deliver negative pressure to the wound site, even with low to moderate amounts of fluid saturation in the dressing 1; If ...

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pubmed.ncbi.nlm.nih.gov/31679202/

Effectiveness of Negative-Pressure Wound Therapy ...

In this review, we assess the effects of negative-pressure wound therapy (NPWT) following primary hip and knee replacement surgery with a systematic review ...

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The Avance Solo system, a single-patient-use NPWT device, enhances patient mobility and comfort while minimizing pain during dressing changes, demonstrating ...

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cdn.clinicaltrials.gov/large-docs/16/NCT05427916/Prot_SAP_000.pdf

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The purpose of this study is to assess the efficacy of the FDA cleared device,. Avance® Solo, an device that delivers negative pressure wound ...

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magonlinelibrary.com

magonlinelibrary.com/doi/10.12968/jowc.2024.0033

A new portable negative pressure wound therapy device

In this study, the suNPWT system supported the healing of closed surgical incisions with no safety concerns relating to its use.

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molnlycke.us/solutions/avancesolo/

Introducing Avance® Solo

A portable single patient use negative pressure system. · A multi-layer, advanced surgical dressing with Safetac® adhesive · A -125mmHg pump for consistent, ...

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AVANCE SOLO AND AVANCE SOLO ADAPT

Avance Solo is a portable single patient use negative pressure system that delivers negative pressure to the wound site while transporting exudate from the ...

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woundsinternational.com/wp-content/uploads/2023/02/d5defab56a3ded1838880713c7791a6b.pdf

Download pdf

The second part of this supplement introduces the Avance® Solo Negative Pressure Wound Therapy. (NPWT) System, focusing on the findings of recent research that ...