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Antimicrobial Barrier Dressing Versus Closed-incision Negative Pressure Therapy in the Obese Primary Total Joint Arthroplasty

NCT03345771 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2022-04-22

Study results available
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Summary

The purpose of this study is to determine whether an occlusive antimicrobial barrier dressing or portable negative pressure wound dressing is superior in preventing wound complications and infection rates in obese patients undergoing total joint arthroplasty (TJA). Approximately 240 subjects (120 for total knee arthroplasty and 120 for total hip arthroplasty) will be enrolled to evaluate the outcomes associated with silver impregnated dressings and negative pressure wound therapy (NPWT) in treating this subset of patients and analyze the cost benefit of each.

Conditions

Interventions

COMBINATION_PRODUCT

Antimicrobial Barrier Dressing

Ionic Silver is a soft, nonwoven pad or ribbon that features the gelling benefits of Hydrofiber technology plus antimicrobial ionic silver.

DEVICE

Negative Pressure Wound Therapy (NPWT)

PICO provides suction known as negative Pressure wound Therapy (NPWT) which draws out excess fluid from a wound and protects the injured area from getting dirty to ultimately help promote healing. PICO consists of an nPwT pump connected to an absorbent gentle adhesive dressing

Sponsors & Collaborators

Principal Investigators

  • Ran Schwarzkopf, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-13
Primary Completion
2021-04-01
Completion
2021-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03345771 on ClinicalTrials.gov