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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02064270
Recruitment Status : Completed
First Posted : February 17, 2014
Results First Posted : April 17, 2018
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
Smith & Nephew, Inc.
Information provided by (Responsible Party):
James Stannard, University of Missouri-Columbia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Wound of Knee Wound of Hip Device: Single-Use Negative Pressure Wound Therapy Device: Standard postsurgical dressings Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 526 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : March 2014
Actual Primary Completion Date : September 7, 2017
Actual Study Completion Date : September 7, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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:
  • NPWT
  • PICO
Active Comparator: Standard dressings
Standard postsurgical dressings
 Device: Standard postsurgical dressings
Use of Standard postsurgical dressings


Outcome Measures
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Primary Outcome Measures :
  1. Incision Appearance Based on VAS (Incision Healing Assessment Form) [ Time Frame: 35 days (+/- 14 days) ]
    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.


Secondary Outcome Measures :
  1. Drainage Amount [ Time Frame: 35 days (+/- 14 days) ]

    Incision Drainage:

    1. None
    2. Slight (barely noticed)
    3. Moderate (significant amount, but did not have to change dressing)
    4. Extensive (had to change dressing)

  2. User-friendliness for Patient [ Time Frame: 7 days ]

    User-Friendliness of PICO device:

    1. Easy to use (no difficulties, no instruction needed)
    2. Slightly difficult (needed instruction)
    3. Minor difficulties (but able to use effectively)
    4. Difficult (not able to use effectively)

  3. Number of Participants With Complications [ Time Frame: 35 days (+/- 14 days) ]
    Complications experienced by the subject within the study period time-frame will be recorded.

  4. Return to the Operating Room [ Time Frame: 35 days (+/- 14 days) ]
    Information regarding the subject returning to the operating room within the research study time-frame will be recorded.

  5. Need for Antibiotics [ Time Frame: 35 days (+/- 14 days) ]
    The need for additional antibiotics will be recorded.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02064270


Locations
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United States, Missouri
University of Missouri Health System
Columbia, Missouri, United States, 65212
Sponsors and Collaborators
University of Missouri-Columbia
Smith & Nephew, Inc.
Investigators
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Principal Investigator: James P Stannard, MD University of Missouri-Columbia
  Study Documents (Full-Text)

Documents provided by James Stannard, University of Missouri-Columbia:
Informed Consent Form  [PDF] April 27, 2017
Study Protocol and Statistical Analysis Plan  [PDF] March 24, 2016

More Information
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Responsible Party: James Stannard, Medical Director, Missouri Orthopaedic Institute; Chairman, Department of Orthopaedic Surgery, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT02064270    
Other Study ID Numbers: 1208434
First Posted: February 17, 2014    Key Record Dates
Results First Posted: April 17, 2018
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by James Stannard, University of Missouri-Columbia:
incision care
Total Hip Arthroplasty
Total Knee Arthroplasty
Knee surgery
Hip surgery
Additional relevant MeSH terms:
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Wounds and Injuries