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

NCT ID: NCT02064270

Last Updated: 2018-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 526 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2017-09-07

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.

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.

Conditions

Wound of Knee; Wound of Hip

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Negative Pressure Wound Therapy

Single-Use Negative Pressure Wound Therapy (NPWT)

Group Type: ACTIVE_COMPARATOR

Single-Use Negative Pressure Wound Therapy

Intervention Type: DEVICE

Application of PICO Single-Use Negative Pressure Wound Therapy

Standard dressings

Standard postsurgical dressings

Group Type: ACTIVE_COMPARATOR

Standard postsurgical dressings

Intervention Type: DEVICE

Use of Standard postsurgical dressings

Interventions

Single-Use Negative Pressure Wound Therapy

Application of PICO Single-Use Negative Pressure Wound Therapy

Intervention Type: DEVICE

Standard postsurgical dressings

Use of Standard postsurgical dressings

Intervention Type: DEVICE

Other Intervention Names

NPWT; PICO

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Missouri-Columbia

OTHER

Sponsor Role: lead

Responsible Party

James Stannard

Medical Director, Missouri Orthopaedic Institute; Chairman, Department of Orthopaedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James P Stannard, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

University of Missouri Health System

Columbia, Missouri, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1208434

Identifier Type: -

Identifier Source: org_study_id