Study to Compare Negative Pressure Wound Therapy or Standard Dressings After Orthopedic Surgery (PICO)

Prospective Randomized, Controlled Study to Assess Prevention of Incision Healing Complications in Patients Undergoing Total Knee or Hip Arthroplasty, Treated With Either Negative Pressure Wound Therapy or Standard Dressings.

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.

Study Overview

• Status: Completed
• Conditions: Wound of Knee; Wound of Hip
• Intervention / Treatment: Device: Single-Use Negative Pressure Wound Therapy; Device: Standard postsurgical dressings

Detailed Description

Most surgical wounds heal by primary intention, meaning the wound edges are brought together, or approximated, by some sort of mechanical means (sutures, staples, paper tape, surgical glue or adhesive strips) to heal with minimal scar formation. National clinical guidelines recommend that incisions are covered with a postsurgical cover dressing, for up to a period of 48 hours, to help control postoperative bleeding, absorb exudate, provide mechanical protection, help to reduce edema and provide protection from exogenous sources. Multiple patient comorbidities, environmental factors and the type and length of surgery may elevate certain groups of patients into a higher level of risk of developing a post-surgical complication: calling for a higher degree of vigilance and postsurgical intervention. Surgical complications include; wound dehiscence, infection (deep or superficial), hematomas, seromas, tissue necrosis and delayed incision healing. Complication rates can range from 19% in patients requiring open reduction and internal fixation (ORIF) of tibial plateau, pilon and calcaneus fractures up to 50% in high energy trauma wounds. These complications can have a high degree of morbidity for the patient and further sequelae may result in additional surgical procedures or revisions, a lower functional status for the patient, an increased in length of hospital stay (LOS) and a higher cost for the healthcare provider.

Traditional NPWT has been shown to be an effective adjunct therapy in the treatment of acute and chronic wounds, but the emergence of incisional NPWT (iNPWT) and supporting evidence is growing momentum. In vitro studies have shown that iNPWT may help to improve the stimulation of blood flow, help manage exudate, help to reduce edema, provide a mechanical and "splinting" effect on the incision and provide mechanical protection from the environment. Its impact on the prevention or reduction of post-surgical incision complications is still in its infancy, but recent studies have been encouraging and have demonstrated a statistically significant reduction in infection and dehiscence in patients considered as high-risk following severe skeletal trauma.

The aim of this study is to assess the prevention of incision healing complications in patients undergoing TKA and THA treated with either Single-Use Incisional NPWT compared to standard of care dressings.

• Study Type: Interventional
• Enrollment (Actual): 526
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. - Patients who in the opinion of the investigator may not complete the study for any reason
2. - Patients with a known history of poor compliance with medical treatment
3. - Patients who have participated in this trial previously and who were withdrawn
4. - 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)
5. - Patients not capable of obtaining a standardized digital picture at day 7 (1 week from surgery), and submitting it to the site.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Negative Pressure Wound Therapy; Single-Use Negative Pressure Wound Therapy (NPWT)	Device: Single-Use Negative Pressure Wound Therapy; Application of PICO Single-Use Negative Pressure Wound Therapy; Other Names: PICO; NPWT
Active Comparator: Standard dressings; Standard postsurgical dressings	Device: Standard postsurgical dressings; Use of Standard postsurgical dressings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Drainage Amount	Incision Drainage: None; Slight (barely noticed); Moderate (significant amount, but did not have to change dressing); Extensive (had to change dressing)	35 days (+/- 14 days)
User-friendliness for Patient	User-Friendliness of PICO device: Easy to use (no difficulties, no instruction needed); Slightly difficult (needed instruction); Minor difficulties (but able to use effectively); Difficult (not able to use effectively)	7 days
Number of Participants With Complications	Complications experienced by the subject within the study period time-frame will be recorded.	35 days (+/- 14 days)
Return to the Operating Room	Information regarding the subject returning to the operating room within the research study time-frame will be recorded.	35 days (+/- 14 days)
Need for Antibiotics	The need for additional antibiotics will be recorded.	35 days (+/- 14 days)

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Collaborators: Smith & Nephew, Inc.
• Investigators: Principal Investigator: James P Stannard, MD, University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): September 7, 2017
• Study Completion (Actual): September 7, 2017

Study Registration Dates

• First Submitted: February 6, 2014
• First Submitted That Met QC Criteria: February 13, 2014
• First Posted (Estimate): February 17, 2014

Study Record Updates

• Last Update Posted (Actual): April 17, 2018
• Last Update Submitted That Met QC Criteria: April 13, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Total Knee Arthroplasty; Total Hip Arthroplasty; Knee surgery; Hip surgery; incision care
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 1208434

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO