NCT02064270

Brief Summary

The aim of this study is to assess the prevention of incision healing complications in patients undergoing Total Knee Arthroscopy (TKA) and Total Hip Arthroscopy (THA) treated with either Single-Use Incisional NPWT (Negative Pressure Wound Therapy), or standard of care dressings.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
526

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 17, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2017

Completed
7 months until next milestone

Results Posted

Study results publicly available

April 17, 2018

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

3.5 years

First QC Date

February 6, 2014

Results QC Date

March 12, 2018

Last Update Submit

April 13, 2018

Conditions

Wound of KneeWound of Hip

Keywords

incision careTotal Hip ArthroplastyTotal Knee ArthroplastyKnee surgeryHip surgery

Outcome Measures

Primary Outcomes (1)

  • Incision Appearance Based on VAS (Incision Healing Assessment Form)

    Visual Analog Pain Scale (VAS): PICO Study Incision Healing Assessment Form. Used to represent the assessment of incision healing based on in-person visual appearance, or appearance based on standard digital photograph. This number is reported as a total score on a 0-100 scale, with 0 being poor incision healing and 100 being excellent incision healing.

    35 days (+/- 14 days)

Secondary Outcomes (5)

  • Drainage Amount

    35 days (+/- 14 days)

  • User-friendliness for Patient

    7 days

  • Number of Participants With Complications

    35 days (+/- 14 days)

  • Return to the Operating Room

    35 days (+/- 14 days)

  • Need for Antibiotics

    35 days (+/- 14 days)

Study Arms (2)

Negative Pressure Wound Therapy

ACTIVE COMPARATOR

Single-Use Negative Pressure Wound Therapy (NPWT)

Device: Single-Use Negative Pressure Wound Therapy

Standard dressings

ACTIVE COMPARATOR

Standard postsurgical dressings

Device: Standard postsurgical dressings

Interventions

Single-Use Negative Pressure Wound TherapyDEVICE

Application of PICO Single-Use Negative Pressure Wound Therapy

Also known as: NPWT, PICO
Negative Pressure Wound Therapy
Standard postsurgical dressingsDEVICE

Use of Standard postsurgical dressings

Standard dressings

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patient ≥18 years old
  • \- Male or non-pregnant females
  • \- Patient is scheduled to have a surgical procedure for Total Knee Arthroplasty or Total Hip Arthroplasty (Primary or Revision Procedure)
  • \- The patient is able to understand the trial and is willing to consent to the trial

You may not qualify if:

  • \- Patients who in the opinion of the investigator may not complete the study for any reason
  • \- Patients with a known history of poor compliance with medical treatment
  • \- Patients who have participated in this trial previously and who were withdrawn
  • \- Patients with known allergies to product components (silicone adhesives and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within the dressing)
  • \- Patients not capable of obtaining a standardized digital picture at day 7 (1 week from surgery), and submitting it to the site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri Health System

Columbia, Missouri, 65212, United States

Location

Results Point of Contact

Title
Stacee Clawson, Research Manager
Organization
University of Missouri, Department of Orthopaedic Surgery
clawsons@health.missouri.edu
5738849017

Study Officials

  • James P Stannard, MD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director, Missouri Orthopaedic Institute; Chairman, Department of Orthopaedic Surgery

Study Record Dates

First Submitted

February 6, 2014

First Posted

February 17, 2014

Study Start

March 1, 2014

Primary Completion

September 7, 2017

Study Completion

September 7, 2017

Last Updated

April 17, 2018

Results First Posted

April 17, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)