Surgical Procedure, Unspecified
Conditions
Keywords
Prevena Incision Management System (PIMS), Surgical Site Infection (SSI)
Brief summary
The purpose of this research study is to investigate if a new negative pressure incision (surgical cut) management system, could reduce the occurrence of groin wound infections after vascular surgery. This is a single use, sterile dressing that is applied to the patient's skin. It has an attached battery-powered unit that provides negative pressure (a vacuum environment) to the dressing and a disposable canister for the collection of wound fluids. The patient is being asked to participate in this study because the patient is planning to have a vascular surgery procedure that involves groin incision.
Detailed description
Surgical site infection (SSI) in groin wounds after vascular surgery is a significant contributing factor for increased morbidity. Despite the use of prophylactic systemic antibiotics, postoperative groin wound infection still occurs in some circumstances and it continues to be a serious problem after vascular surgical procedures. The incidence of SSI varies from 5 - 40%, and depending upon the depth of infection and type of vascular procedure, the morbidity could range from prolonged hospital stay to limb loss. Increased incidence of SSIs in patients is related to systemic factors like Diabetes, hypertension (HTN), history of smoking, chronic obstructive pulmonary disease (COPD), and local factors like disruption of lymphatics, groin proximity to the perineum, previous surgery at the same site and the use of prosthetic graft material. Prophylactic systemic antibiotics have been routinely used in all vascular surgery procedures, and despite of gentle tissue handling, proper hemostasis and other technical points to minimize tissue trauma, SSIs do happen. The investigators hypothesize that using a closed dressing system with negative pressure will keep the surgical site protected from nearby contaminated field and decrease the risk of infection
Interventions
The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period.
Sponsors
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Older than 18 years 2. Subjects are capable of giving informed written consent 3. Undergoing a vascular surgery procedure that involves a groin incision at North Shore University Hospital and Long Island Jewish Hospital.
Exclusion criteria
1. The patient has a history of blood clotting disorders 2. Patient has evidence of infection in the groin area, where surgical procedure is planned 3. Patient body habitus precludes placement of Prevena dressing. 4. Allergy to Silver or acrylic adhesive
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Wound Infection With Szilagyi Grade | 30 days | This study was terminated prior to gathering of data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess the Safety of the Devise by Monitoring Incidence of Bleeding , Seroma Formation | 30 days | This study was terminated prior to collection of data. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Not Obese:BMI<30; Standard Care Not obese:BMI\<30;Standard Wound Care | 4 |
| Obese:BMI≥30; Standard Care Obese:BMI≥30;Standard Wound Care | 1 |
| Not Obese:BMI<30; Wound Vac Using Prevena Incision Management System
Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period. | 4 |
| Obese:BMI≥30; Wound Vac Using Prevena Incision Management System
Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period. | 0 |
| Total | 9 |
Baseline characteristics
| Characteristic | Not Obese:BMI<30; Standard Care | Obese:BMI≥30; Standard Care | Not Obese:BMI<30; Wound Vac | Obese:BMI≥30; Wound Vac | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 1 Participants | 4 Participants | 0 Participants | 9 Participants |
| Gender Female | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants |
| Gender Male | 2 Participants | 0 Participants | 4 Participants | 0 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 4 | 1 / 1 | 0 / 4 | 0 / 0 |
| serious Total, serious adverse events | 0 / 4 | 0 / 1 | 0 / 4 | 0 / 0 |
Outcome results
Primary
Incidence of Wound Infection With Szilagyi Grade
This study was terminated prior to gathering of data.
Time frame: 30 days
Secondary
Assess the Safety of the Devise by Monitoring Incidence of Bleeding , Seroma Formation
This study was terminated prior to collection of data.
Time frame: 30 days