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| Name | Class |
|---|---|
| Kinetic Concepts, Inc. | INDUSTRY |
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The purpose of this study is to compare the rate of surgical site infection between traditional wound care and negative pressure wound therapy. Wounds will be assessed 4-5 days after surgery and at the first clinic visit after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Negative Pressure Wound Therapy | Active Comparator | The Prevena Incision Management System is a 510K cleared device that covers and protects the incision from external infectious sources, while negative pressure removes fluid and infectious material from the surgical incision. The ActiVAC pump (also 510K cleared) may be used in some cases with the Prevena dressings as to achieve the negative pressure |
|
| Conventional wound therapy | Active Comparator | Traditional wound therapy (sterile bandages and dressing) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional wound therapy | Device | Sterile bandages and wound coverings |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With a Surgical Site Infection | Number and percentage of participants with at least 1 surgical site infection (SSI). | 30 days after surgery; assessed at 4-5 days and 30 days post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Surgical Site Infections by Type | Each surgical site infection was classified into one of the following categories: superficial incisional, deep incisional, or organ/space (as defined by The American College of Surgeons NSQIP [National Surgical Quality Improvement Program] guidelines). The number of infections in each category is reported separately for both treatment arms. Some participants had multiple infections. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dan Blazer, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46223 | United States | ||
| Duke University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36728375 | Derived | Ceppa EP, Kim RC, Niedzwiecki D, Lowe ME, Warren DA, House MG, Nakeeb A, Zani S, Moyer AN, Blazer DG 3rd; Closed Incision Negative Pressure Therapy (ciNPT) Investigators. Closed Incision Negative Pressure Therapy to Reduce Surgical Site Infection in High-Risk Gastrointestinal Surgery: A Randomized Controlled Trial. J Am Coll Surg. 2023 Apr 1;236(4):698-708. doi: 10.1097/XCS.0000000000000547. Epub 2023 Jan 10. |
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Subjects were enrolled at Duke University Medical Center from December 18, 2013 to April 8, 2021 and at Indiana University from December 12, 2016 to April 8, 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | Negative Pressure Wound Therapy | The Prevena Incision Management System is a 510K cleared device that covers and protects the incision from external infectious sources, while negative pressure removes fluid and infectious material from the surgical incision. The ActiVAC pump (also 510K cleared) may be used in some cases with the Prevena dressings as to achieve the negative pressure. |
| FG001 | Conventional Wound Therapy | Sterile bandages and dressings. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Negative Pressure Wound Therapy | The Prevena Incision Management System is a 510K cleared device that covers and protects the incision from external infectious sources, while negative pressure removes fluid and infectious material from the surgical incision. The ActiVAC pump (also 510K cleared) may be used in some cases with the Prevena dressings as to achieve the negative pressure. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Participants With a Surgical Site Infection | Number and percentage of participants with at least 1 surgical site infection (SSI). | Participants who completed the study. | Posted | Count of Participants | Participants | 30 days after surgery; assessed at 4-5 days and 30 days post-operation |
|
30 days after surgery
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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 | Negative Pressure Wound Therapy | The Prevena Incision Management System is a 510K cleared device that covers and protects the incision from external infectious sources, while negative pressure removes fluid and infectious material from the surgical incision. The ActiVAC pump (also 510K cleared) may be used in some cases with the Prevena dressings as to achieve the negative pressure. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash, Grade 2 | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dan Blazer III, MD | Duke University Medical Center | 919-668-1861 | trey.blazer@duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 31, 2020 | May 20, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 21, 2020 | May 20, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D054843 | Negative-Pressure Wound Therapy |
| ID | Term |
|---|---|
| D004322 | Drainage |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D058106 | Wound Closure Techniques |
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| Negative pressure wound therapy |
| Device |
The Prevena Incision Management System covers and protects the incision from external infectious sources, while negative pressure removes fluid and infectious material from the surgical incision. The ActiVAC pump may be used with the Prevena dressings as well in some situations to achieve negative pressure. |
|
|
| 30 days post-surgery |
| Length of Hospital Stay | Assess (or compare) the length of hospital stay between subjects who receive standard of care and incisional V.A.C. via PIMS. | Up to 62 days post-surgery |
| Durham |
| North Carolina |
| 27710 |
| United States |
| Surgery canceled/aborted |
|
| Incision < 7 cm |
|
| Wrong treatment |
|
| Device not applied |
|
| Dressing not applied in operating room |
|
| Wound vac turned off due to device alarm |
|
| BG001 | Conventional Wound Therapy | Sterile bandages and dressings. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
Sterile bandages and dressings. |
|
|
|
| Secondary | Number of Surgical Site Infections by Type | Each surgical site infection was classified into one of the following categories: superficial incisional, deep incisional, or organ/space (as defined by The American College of Surgeons NSQIP [National Surgical Quality Improvement Program] guidelines). The number of infections in each category is reported separately for both treatment arms. Some participants had multiple infections. | Posted | Count of Units | infections | 30 days post-surgery | infections | infections |
|
|
|
| Secondary | Length of Hospital Stay | Assess (or compare) the length of hospital stay between subjects who receive standard of care and incisional V.A.C. via PIMS. | Posted | Median | Full Range | days | Up to 62 days post-surgery |
|
|
|
| 0 |
| 63 |
| 0 |
| 63 |
| 1 |
| 63 |
| EG001 | Conventional Wound Therapy | Sterile bandages and dressings. | 1 | 75 | 0 | 75 | 0 | 75 |
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| Organ/Space |
|