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The purpose of this study is to determine if the application of a negative pressure dressing intraoperatively (Prevena; KCI, Inc) to vascular groin incisions decreases the wound complication rate in high risk patients.
The study randomizes patients (1:1) considered high risk, according to a specific set of risk factors, for wound complications into standard post-op dressings vs. Prevena vacuum dressing. The wounds will then be assessed for wound complications in the 30 days postoperatively. Wound complications include breakdown, infection and lymph leak. Patients not considered high risk will have standard post-op dressings and followed similarly to controls. The investigators will also assess economic impact of negative pressure dressing on length of stay and overall inpatient costs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Risk - Prevena Care | Experimental | The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days. |
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| High Risk - Dry Gauze Dressing Care | Active Comparator | Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily |
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| Low Risk - Dry Gauze Dressing Care | Active Comparator | Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prevena Care | Device | The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Groin Wound Complication | Composite measure including wound dehiscence (skin or fascia), lymph leak (seroma or fistula), infection (deep or superficial), or hematoma | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Length of Stay | Readmission to inpatient hospital for management of wound complications | 30 days |
| Return to Operating Room | Return to operating room for surgical management of wound complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul DiMuzio, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41159585 | Derived | Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10(10):CD015022. doi: 10.1002/14651858.CD015022.pub2. | |
| 40260835 | Derived | Cristino MA, Nakano LC, Vasconcelos V, Correia RM, Flumignan RL. Prevention of infection in aortic or aortoiliac peripheral arterial reconstruction. Cochrane Database Syst Rev. 2025 Apr 22;4(4):CD015192. doi: 10.1002/14651858.CD015192.pub2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | High Risk - Prevena Care | The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days. Prevena Care: The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Dry gauze dressing care | Device | Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily |
|
| 30 days |
| Hospital Readmission | Readmission for wound complication | 30 days |
| Index Hospital Cost | Index Hospital Cost | 30 days |
| 30126781 | Derived | Kwon J, Staley C, McCullough M, Goss S, Arosemena M, Abai B, Salvatore D, Reiter D, DiMuzio P. A randomized clinical trial evaluating negative pressure therapy to decrease vascular groin incision complications. J Vasc Surg. 2018 Dec;68(6):1744-1752. doi: 10.1016/j.jvs.2018.05.224. Epub 2018 Aug 17. |
| FG001 | High Risk - Dry Gauze Dressing Care | Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily Dry gauze dressing care: Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily |
| FG002 | Low Risk - Dry Gauze Dressing Care | Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily Dry gauze dressing care: Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | High Risk - Prevena Care | The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days. Prevena Care: The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days. |
| BG001 | High Risk - Dry Gauze Dressing Care | Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily Dry gauze dressing care: Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily |
| BG002 | Low Risk - Dry Gauze Dressing Care | Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily Dry gauze dressing care: Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Groin Wound Complication | Composite measure including wound dehiscence (skin or fascia), lymph leak (seroma or fistula), infection (deep or superficial), or hematoma | Posted | Count of Participants | Participants | 30 days |
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| Secondary | Hospital Length of Stay | Readmission to inpatient hospital for management of wound complications | Posted | Mean | Standard Deviation | days | 30 days |
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| Secondary | Return to Operating Room | Return to operating room for surgical management of wound complications | Posted | Count of Participants | Participants | 30 days |
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| Secondary | Hospital Readmission | Readmission for wound complication | Posted | Count of Participants | Participants | 30 days |
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| Secondary | Index Hospital Cost | Index Hospital Cost | Posted | Mean | Standard Deviation | USD | 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 | High Risk - Prevena Care | The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days. Prevena Care: The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days. | 0 | 59 | 2 | 59 | 0 | 59 |
| EG001 | High Risk - Dry Gauze Dressing Care | Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily Dry gauze dressing care: Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily | 1 | 60 | 1 | 60 | 0 | 60 |
| EG002 | Low Risk - Dry Gauze Dressing Care | Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily Dry gauze dressing care: Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily | 0 | 21 | 0 | 21 | 0 | 21 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| PAD Bypass Graft Thrombosis | Vascular disorders |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul DiMuzio, MD | Thomas Jefferson University | 2159558304 | paul.dimuzio@jefferson.edu |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D058729 | Peripheral Arterial Disease |
| D000783 | Aneurysm |
| D013529 | Surgical Wound Dehiscence |
| ID | Term |
|---|---|
| D007239 | Infections |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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