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

NCT03345771 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 17-00496
• Study Type: interventional
• Target: 230
• Locations: 1 country
• Sites: 1

Brief 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

Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale (VAS) Pain Score

  A patient is asked to indicate his/her perceived scar severity along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (worst possible scar) to 100 (best possible scar); the higher the score, the better the scarring.

  Day 8

• Wound Evaluation Scale (WES)

  WES is a 6-item scale. Items 1-5 are scored 0 (yes) or 1 (no), and item 6 is scored 0 (poor) or 1 (acceptable). The total score range is 0-6; the higher the score, the more optimal the wound healing.

  Day 8

Study Arms (2)

Antimicrobial Barrier Dressing

ACTIVE COMPARATOR

postoperative wound dressing with either anti-microbial dressing placed in the operating room from surgery to postoperative day 7

Combination Product: Antimicrobial Barrier Dressing

Closed-incision Negative Pressure Therapy

ACTIVE COMPARATOR

portable NPWT device placed in the operating room from surgery to postoperative day 7

Device: Negative Pressure Wound Therapy (NPWT)

Interventions

Antimicrobial Barrier Dressing COMBINATION_PRODUCT

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

Also known as: AQUACEL Ag Hydrofiber Dressing

Antimicrobial Barrier Dressing

Negative Pressure Wound Therapy (NPWT) DEVICE

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

Also known as: PICO

Closed-incision Negative Pressure Therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those identified at pre-operative testing to have an elevated BMI (\> 35)

You may not qualify if:

• Active infection
• previous scar or wound healing complication
• post traumatic degenerative joint disease (DJD) with hardware
• revision surgery
• inflammatory arthritis
• anticoagulation outside of the standard of care.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Results Point of Contact

• Title: Ran Schwarzkopf MD MSc
• Organization: NYU Langone Health

ran.schwarzkopf@nyulangone.org

(646)-501-7300

Study Officials

• Ran Schwarzkopf, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: November 17, 2017
• Study Start: November 13, 2017
• Primary Completion: April 1, 2021
• Study Completion: June 1, 2021
• Last Updated: April 22, 2022
• Results First Posted: April 22, 2022

Record last verified: 2022-03

Locations

US (1)