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

201 Participants Needed

Trial Summary

What is the purpose of this trial?

Wound complications and surgical site infections following revision total joint arthroplasty result in significant morbidity and cost. To the investigators knowledge, no prospective, randomized controlled trials have examined the rate of wound complications, infection, and reoperation following revision total hip arthroplasty when treated with negative pressure wound therapy (NPWT) versus sterile dressings. The investigators hypothesize that the rate of wound complications, infections, and subsequent procedures in patients undergoing revision THA treatment will demonstrate a statistically and clinically relevant decrease when using NPWT versus sterile dressing.

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 data supports the effectiveness of the treatment Negative Pressure Wound Therapy (NPWT) for hip surgery recovery?

Research shows that Negative Pressure Wound Therapy (NPWT) can improve wound healing and reduce complications like seromas (fluid buildup) after hip surgery. It has also been found to help prevent infections in hip and knee surgeries compared to regular dressings. ^{1 2 3 4 5}

Is Negative Pressure Wound Therapy (NPWT) safe for humans?

Research shows that Negative Pressure Wound Therapy (NPWT) is generally safe for humans, as it is used to improve wound healing after surgeries like hip and knee replacements. It helps prevent complications such as seromas (fluid build-up) and infections, which suggests it is a safe option for managing surgical wounds. ^{1 2 5 6 7}

How does the treatment NPWT differ from conventional dressings for hip surgery recovery?

Negative pressure wound therapy (NPWT) is unique because it uses a vacuum to promote healing by removing excess fluid and reducing swelling, which can help prevent complications like seromas (fluid buildup) and infections after hip surgery. This is different from conventional dressings, which simply cover the wound without actively managing fluid or pressure. ^{1 2 3 5 8}

Research Team

Denis Nam, MD, MSc

Principal Investigator

Rush University Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Postoperative wound management with negative pressure wound therapy in knee and hip surgery: a randomised control trial. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

Negative pressure wound therapy to prevent seromas and treat surgical incisions after total hip arthroplasty. [2022]

3. Brazil pubmed.ncbi.nlm.nih.gov

INCISIONAL NEGATIVE-PRESSURE WOUND THERAPY IN REVISION TOTAL HIP ARTHROPLASTY DUE TO INFECTION. [2022]

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

A New Dressing System for Wound in Enhanced-Recovery Total Hip Arthroplasty: A Randomized and Controlled Trial. [2023]

5. England pubmed.ncbi.nlm.nih.gov

The effectiveness of prophylactic closed incision negative pressure wound therapy compared to conventional dressings in the prevention of periprosthetic joint infection post hip and knee revision arthroplasty surgery: A systematic review. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Wound dressing following primary total hip arthroplasty: a prospective randomised controlled trial. [2022]

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

Polyester mesh dressings reduce delayed wound healing rates after total hip arthroplasty compared with silver-impregnated occlusive dressings. [2022]

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

Effectiveness of Negative-Pressure Wound Therapy following Total Hip and Knee Replacements. [2020]