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PI Decision
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Not obese:BMI<30; Standard Care | No Intervention | Standard Wound Care | |
| Obese:BMI≥30; Standard Care | No Intervention | Standard Wound Care | |
| Not Obese:BMI<30; Wound Vac | Other | Using Prevena Incision Management System |
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| Obese:BMI≥30; Wound Vac | Other | Using Prevena Incision Management System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevena Incision Management System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Wound Infection With Szilagyi Grade | This study was terminated prior to gathering of data. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the Safety of the Devise by Monitoring Incidence of Bleeding , Seroma Formation | This study was terminated prior to collection of data. | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kambhampaty Krishnasastry, MD | Northwell Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Shore-LIJ Health System | Lake Success | New York | 11042 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23312938 | Background | Matatov T, Reddy KN, Doucet LD, Zhao CX, Zhang WW. Experience with a new negative pressure incision management system in prevention of groin wound infection in vascular surgery patients. J Vasc Surg. 2013 Mar;57(3):791-5. doi: 10.1016/j.jvs.2012.09.037. Epub 2013 Jan 9. | |
| 22145641 | Background | Colli A, Camara ML. First experience with a new negative pressure incision management system on surgical incisions after cardiac surgery in high risk patients. J Cardiothorac Surg. 2011 Dec 6;6:160. doi: 10.1186/1749-8090-6-160. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Not Obese:BMI<30; Standard Care | Not obese: BMI< 30; Standard Wound Care |
| FG001 | Obese:BMI≥30; Standard Care | Obese: BMI ≥30; Standard Wound Care |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Not Obese:BMI<30; Standard Care | Not obese:BMI<30;Standard Wound Care |
| BG001 | Obese:BMI≥30; Standard Care | Obese:BMI≥30;Standard Wound Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Wound Infection With Szilagyi Grade | This study was terminated prior to gathering of data. | Posted | 30 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Not Obese:BMI<30; Standard Care | Not obese:BMI<30;Standard Wound Care |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infection | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kambhampaty Krishnasastry | Northwell Health System | 516-233-3643 | kkrishna@northwell.edu |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Gender | Count of Participants | Participants |
|
| OG003 | 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. |
|
| Secondary | Assess the Safety of the Devise by Monitoring Incidence of Bleeding , Seroma Formation | This study was terminated prior to collection of data. | Posted | 30 days |
|
|
| 0 |
| 4 |
| 1 |
| 4 |
| EG001 | Obese:BMI≥30; Standard Care | Obese:BMI≥30;Standard Wound Care | 0 | 1 | 1 | 1 |
| EG002 | 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. | 0 | 4 | 0 | 4 |
| EG003 | 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 | 0 | 0 | 0 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |