NPWT vs Conventional Dressings for Hip Surgery Recovery

Overseen By Anne DeBenedetti, BA

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Rush University Medical Center

Disqualifiers: Pregnancy, Lactation, Silver allergy, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of bandages to determine which aids recovery better after hip surgery. One group will use standard sterile dressings, while the other will use a special bandage called negative pressure wound therapy (NPWT), which might reduce wound issues and infections. Researchers aim to discover if NPWT results in fewer complications and less need for additional surgeries. This trial suits individuals recovering from specific hip surgeries, such as revision total hip arthroplasty (THA) for repairing loose parts or infections, who can have their incision closed without extra skin or muscle work. Participants must be willing to try one of the bandages and attend follow-up visits. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative 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.

What prior data suggests that negative pressure wound therapy (NPWT) is safe for hip surgery recovery?

Research has shown that negative pressure wound therapy (NPWT) is safe for hip revision surgeries. One study found that NPWT did not cause any problems in these surgeries. Another study found that NPWT helped lower the risk of deep infections after bone surgery. However, some patients experienced blisters while using NPWT.

Overall, NPWT appears to reduce the risk of infection and other wound issues after surgery. It is important to note that minor skin reactions, such as blisters, can occur. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about negative pressure wound therapy (NPWT) for hip surgery recovery because it offers a different approach to healing compared to conventional sterile antimicrobial dressings. Unlike standard dressings like AQUACEL, which passively cover the wound, NPWT actively uses suction to promote faster healing and reduce infection risk. This method can potentially lead to more efficient recovery times and better outcomes for patients, making it a promising option in surgical care.

What evidence suggests that NPWT is effective for hip surgery recovery?

Research has shown that Negative Pressure Wound Therapy (NPWT), one of the treatments studied in this trial, can help reduce wound complications after hip surgery. Studies have found that NPWT keeps wounds dry, lowering the risk of infection in 76% of patients. It also results in fewer infections at the surgery site and fewer repeat surgeries compared to regular dressings. This method works by gently removing fluids from the wound, aiding in healing. Overall, NPWT has improved recovery after hip and knee surgeries by reducing the chance of infection and other complications. Participants in this trial will receive either NPWT or Sterile Antimicrobial Dressings, the current hospital standard, to compare their effectiveness in recovery. ^{2 3 6 7 8}

Who Is on the Research Team?

Denis Nam, MD, MSc

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need a revision of their hip replacement surgery. It's open to those with loose components, bone loss, or fractures needing component changes, and infections treated by various methods. Participants must be able to close the wound normally without grafts and agree to follow-up visits.

Exclusion Criteria

I need a muscle flap or skin graft for my wound.

Pregnant or lactating female

Known sensitivity to the study product components

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo revision total hip arthroplasty with either NPWT or sterile dressings applied intra-operatively

1 week

Intra-operative application and 1 follow-up visit for dressing removal

Follow-up

Participants are monitored for wound complications, infections, and reoperations

90 days

Regular follow-up visits as needed for monitoring and interventions

What Are the Treatments Tested in This Trial?

Interventions

• Negative Pressure Wound Therapy (NPWT)
• Revision THA
• Sterile Antimicrobial Dressings

Trial Overview The study compares Negative Pressure Wound Therapy (NPWT) with standard sterile dressings in preventing complications after hip revision surgeries. The goal is to see if NPWT reduces problems like infections and the need for more surgeries better than regular dressings.

How Is the Trial Designed?

Group I: Negative pressure wound therapy (NPWT) Experimental Treatment 1 Intervention

Experimental group. Negative pressure wound therapy bandage applied intra-operatively by a physician on the treatment team. The dressing will be removed after 7 days postoperatively, or if the battery power stops earlier.

Group II: Sterile Antimicrobial Dressings Active Control 1 Intervention

Control group, current hospital standard. AQUACEL is left in place for 7 days unless it becomes saturated over 50%, which requires a premature dressing change.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

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

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3773159/

Negative Pressure Wound Therapy Is Associated With ... The flowchart illustrates the clinical outcomes after use of the NPWT for persistent wound drainage after hip arthroplasty. In 76% of patients, a dry wound was ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1878124123000527

The effectiveness of prophylactic closed incision negative ... Prophylactic application of ciNPWT may be effective in reducing wound complications, PJI and reoperation post hip and knee revision arthroplasty surgery.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03321799

Comparison of Negative Pressure Wound Therapy vs. ... Wound complications within 90 days of a revision total hip arthroplasty include: wound dehiscence, prolonged drainage for >7 days postoperatively, hematoma ...

4. arthroplastyjournal.org arthroplastyjournal.org/article/S0883-5403(22)00321-7/fulltext

Randomized Controlled Trial of Incisional Negative ... Closed incision negative pressure therapy (ciNPT) is effective in reducing SSCs and surgical site infections (SSIs) in other populations.

5. becarispublishing.com becarispublishing.com/doi/10.2217/cer-2019-0009

Negative pressure wound therapy in total hip and knee ... Conclusion: NPWT decreased the incidence of superficial surgical site infection. More blisters were noticed in patients with NPWT after total ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6220663/

INCISIONAL NEGATIVE-PRESSURE WOUND THERAPY ... The main finding of this study was that NPWT may be safely used in revision surgeries of hip prosthesis for chronic infection, without any complications and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11385841/

Effect of negative pressure wound therapy on the incidence ... The results of our study indicate that the prophylactic use of NPWT reduces the incidence of deep SSIs following orthopedic trauma surgery.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0883540315010207

Revision Arthroplasty Closed-Incision Negative-Pressure ... Conclusion. Our findings suggest that ciNPT may decrease wound complications and SSIs in patients undergoing revision hip and knee surgery.