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

Phase 3

Completed

• Conditions: Osteoarthritis
• Interventions: Device: Negative Pressure Wound Therapy (NPWT); Combination Product: Antimicrobial Barrier Dressing

• Registration Number: NCT03345771
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-13
• Study First Submitted: 2017-11-14
• Study First Submitted QC: 2017-11-14
• Study First Posted: 2017-11-17
• Primary Completion: 2021-04-01
• Study Completion: 2021-06-01
• Status Verified: 2022-03
• Results First Submitted: 2022-03-29
• Results First Submitted QC: 2022-03-29
• Last Update Submitted: 2022-03-29
• Results First Posted: 2022-04-22
• Last Update Posted: 2022-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

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

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Closed-incision Negative Pressure Therapy	Negative Pressure Wound Therapy (NPWT)	portable NPWT device placed in the operating room from surgery to postoperative day 7
Antimicrobial Barrier Dressing	Antimicrobial Barrier Dressing	postoperative wound dressing with either anti-microbial dressing placed in the operating room from surgery to postoperative day 7

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) Pain Score	Day 8	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.
Wound Evaluation Scale (WES)	Day 8	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.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States