N/A
N=526
Study to Compare Negative Pressure Wound Therapy or Standard Dressings After Orthopedic Surgery
Wound of Knee · Wound of Hip
Bottom Line
View on ClinicalTrials.gov: NCT02064270 ↗Enrolled (actual)
526
Serious AEs
2.6%
Results posted
Apr 2018
Primary outcome: Primary: Incision Appearance Based on VAS (Incision Healing Assessment Form) — 83.4; 83.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Single-Use Negative Pressure Wound Therapy (Device); Standard postsurgical dressings (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Missouri-Columbia
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incision Appearance Based on VAS (Incision Healing Assessment Form) |
83.4; 83.5 | — |
| SECONDARY Drainage Amount |
178; 211; 9; 9; 4; 2 | — |
| SECONDARY User-friendliness for Patient |
113; 11; 7; 0 | — |
| SECONDARY Number of Participants With Complications |
27; 41 | — |
| SECONDARY Return to the Operating Room |
193; 4; 0; 218 | — |
| SECONDARY Need for Antibiotics |
25; 30; 168; 193 | — |
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.
Eligibility Criteria
Inclusion Criteria
- - 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
Exclusion Criteria
- - 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- - Patients who have participated in this trial previously and who were withdrawn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.
Data sourced from ClinicalTrials.gov (NCT02064270). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.