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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02064270

Acronym

PICO

Enrollment

526

Registered

2014-02-17

Start date

2014-03-31

Completion date

2017-09-07

Last updated

2018-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound of Hip, Wound of Knee

Keywords

incision care, Total Hip Arthroplasty, Total Knee Arthroplasty, Knee surgery, Hip surgery

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.

Interventions

DEVICESingle-Use Negative Pressure Wound Therapy

Application of PICO Single-Use Negative Pressure Wound Therapy

DEVICEStandard postsurgical dressings

Use of Standard postsurgical dressings

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Incision Appearance Based on VAS (Incision Healing Assessment Form)	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

Measure	Time frame	Description
Drainage Amount	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)
User-friendliness for Patient	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)
Number of Participants With Complications	35 days (+/- 14 days)	Complications experienced by the subject within the study period time-frame will be recorded.
Return to the Operating Room	35 days (+/- 14 days)	Information regarding the subject returning to the operating room within the research study time-frame will be recorded.
Need for Antibiotics	35 days (+/- 14 days)	The need for additional antibiotics will be recorded.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Negative Pressure Wound Therapy Single-Use Negative Pressure Wound Therapy (NPWT) Single-Use Negative Pressure Wound Therapy: Application of PICO Single-Use Negative Pressure Wound Therapy	201
Standard Dressings Standard postsurgical dressings Standard postsurgical dressings: Use of Standard postsurgical dressings	231
Total	432

Baseline characteristics

Characteristic	Standard Dressings	Total	Negative Pressure Wound Therapy
Age, Continuous	60.5 years	60.6 years	60.7 years
Race and Ethnicity Not Collected	—	0 Participants	—
Region of Enrollment United States	231 Participants	432 Participants	201 Participants
Sex: Female, Male Female	137 Participants	263 Participants	126 Participants
Sex: Female, Male Male	94 Participants	169 Participants	75 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 201	0 / 231
other Total, other adverse events	3 / 201	5 / 231
serious Total, serious adverse events	5 / 201	6 / 231

Outcome results

Primary

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.