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| Name | Class |
|---|---|
| 3M | INDUSTRY |
| Miami Cancer Institute | OTHER |
The purpose of this study is to compare any good and bad effects of using the Prevena Incision Management System to using the usual standard dry gauze approach. The Prevena Incision Management System is a type of Negative Pressure Wound Therapy (NPWT). NPWT is a portable vacuum device made of a sponge-like foam that is applied over your incision to help draw fluid and debris out after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| usual standard dry gauze used for wound management | Active Comparator | Patients who are randomized to the standard dry gauze arm will have the standard dry gauze placed at time of wound closure. Their dressing will be removed on post-operative day 2 as per routine departmental practice. |
|
| Prevena Negative Pressure Wound Therapy System (NPWT) | Experimental | Patients who are randomized to the Prevena Therapy System arm will have the Prevena Incision Management System device placed at time of wound closure. The device will be removed on day of discharge from the hospital or post-operative day 7, whichever comes first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dry gauze | Other |
| ||
| The Prevena Incision Management System |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Post-op Wound Complications | Incidence of inpatient post-operative wound complications will be documented through the use of an inpatient data collection sheet. Incidence of outpatient post-operative wound complication will be documented through the use of an outpatient data collection sheet that will be completed by a provider at the time of the routine post-operative follow-up visit, which will occur at 30 days +/- 5 days after the day of surgery as well as through ongoing documentation of events as elicited through the institution's standard reporting system to collect information on enrolled patients. | 30 days +/- 5 days after surgery |
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Inclusion Criteria:
Criteria for Eligibility Prior to Surgery:
Criteria for Eligibility During Surgery:
Exclusion Criteria:
Exclusion prior to Surgery:
Exclusion during Surgery:
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| Name | Affiliation | Role |
|---|---|---|
| Mario Leitao, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Healthcare Cancer Institute @ Hartford Hospital | Hartford | Connecticut | 06102 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33416292 | Derived | Leitao MM Jr, Zhou QC, Schiavone MB, Cowan RA, Smith ES, Iasonos A, Veith M, Rafizadeh M, Curran K, Ramesh B, Chang K, Chi DS, Sonoda Y, Brown AK, Cosin JA, Abu-Rustum NR, Martino MA, Mueller JJ, Long Roche K, Jewell EL, Broach V, Lambrou NC, Diaz JP, Zivanovic O. Prophylactic Negative Pressure Wound Therapy After Laparotomy for Gynecologic Surgery: A Randomized Controlled Trial. Obstet Gynecol. 2021 Feb 1;137(2):334-341. doi: 10.1097/AOG.0000000000004243. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Standard Dry Gauze Used for Wound Management | Patients who are randomized to the standard dry gauze arm will have the standard dry gauze placed at time of wound closure. Their dressing will be removed on post-operative day 2 as per routine departmental practice. dry gauze |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Apr 20, 2021 |
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| Device |
|
| Memorial Sloan Kettering Basking Ridge (Consent and Follow-Up only) |
| Basking Ridge |
| New Jersey |
| 07920 |
| United States |
| Memorial Sloan Kettering Monmouth (Consent and Follow-Up only) | Middletown | New Jersey | 07748 | United States |
| Memorial Sloan Kettering Bergen (Consent and Follow-Up only) | Montvale | New Jersey | 07645 | United States |
| Memorial Sloan Kettering Commack (Consent and Follow-Up only) | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Westchester (Consent and Follow-Up only) | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Rockville (Consent and Follow-Up only) | Rockville Centre | New York | 11570 | United States |
| Memorial Sloan Kettering Nassau (Consent and Follow-Up only) | Uniondale | New York | 11553 | United States |
| Lehigh Valley Health Network | Allentown | Pennsylvania | 18103 | United States |
| Prevena Negative Pressure Wound Therapy System (NPWT) |
Patients who are randomized to the Prevena Therapy System arm will have the Prevena Incision Management System device placed at time of wound closure. The device will be removed on day of discharge from the hospital or post-operative day 7, whichever comes first. The Prevena Incision Management System |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Standard Dry Gauze Used for Wound Management | Patients who are randomized to the standard dry gauze arm will have the standard dry gauze placed at time of wound closure. Their dressing will be removed on post-operative day 2 as per routine departmental practice. dry gauze |
| BG001 | Prevena Negative Pressure Wound Therapy System (NPWT) | Patients who are randomized to the Prevena Therapy System arm will have the Prevena Incision Management System device placed at time of wound closure. The device will be removed on day of discharge from the hospital or post-operative day 7, whichever comes first. The Prevena Incision Management System |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | 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 | Number of Post-op Wound Complications | Incidence of inpatient post-operative wound complications will be documented through the use of an inpatient data collection sheet. Incidence of outpatient post-operative wound complication will be documented through the use of an outpatient data collection sheet that will be completed by a provider at the time of the routine post-operative follow-up visit, which will occur at 30 days +/- 5 days after the day of surgery as well as through ongoing documentation of events as elicited through the institution's standard reporting system to collect information on enrolled patients. | Posted | Number | Wound Complications | 30 days +/- 5 days after surgery |
|
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30 days +/- 5 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 | Usual Standard Dry Gauze Used for Wound Management | Patients who are randomized to the standard dry gauze arm will have the standard dry gauze placed at time of wound closure. Their dressing will be removed on post-operative day 2 as per routine departmental practice. dry gauze | 1 | 251 | 51 | 251 | 11 | 251 |
| EG001 | Prevena Negative Pressure Wound Therapy System (NPWT) | Patients who are randomized to the Prevena Therapy System arm will have the Prevena Incision Management System device placed at time of wound closure. The device will be removed on day of discharge from the hospital or post-operative day 7, whichever comes first. The Prevena Incision Management System | 0 | 254 | 69 | 254 | 44 | 254 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal infection | Infections and infestations | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Ascites | Gastrointestinal disorders | Systematic Assessment |
| ||
| Aspartate aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Biliary anastomotic leak | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Biliary fistula | Hepatobiliary disorders | Systematic Assessment |
| ||
| Blood bilirubin increased | Investigations | Systematic Assessment |
| ||
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Colonic perforation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Enterocolitis infectious | Infections and infestations | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Gastrointestinal anastomotic leak | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Hematoma | Vascular disorders | Systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Ileus | Gastrointestinal disorders | Systematic Assessment |
| ||
| Infections and infestations - Other, specify | Infections and infestations | Systematic Assessment |
| ||
| Intraoperative splenic injury | Injury, poisoning and procedural complications | Systematic Assessment |
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| Large intestinal anastomotic leak | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Leukocytosis | Blood and lymphatic system disorders | Systematic Assessment |
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| Localized edema | General disorders | Systematic Assessment |
| ||
| Lung infection | Infections and infestations | Systematic Assessment |
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| Metabolism and nutrition disorders- Other, specify | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| Pain | General disorders | Systematic Assessment |
| ||
| Pancreatic anastomotic leak | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Pelvic infection | Infections and infestations | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Systematic Assessment |
| ||
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Rectal anastomotic leak | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Seroma | Injury, poisoning and procedural complications | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Small intestinal perforation | Gastrointestinal disorders | Systematic Assessment |
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| Surgical and medical procedures - Other, specify | Surgical and medical procedures | Systematic Assessment |
| ||
| Thromboembolic event | Vascular disorders | Systematic Assessment |
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| Ureteric anastomotic leak | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary tract obstruction | Renal and urinary disorders | Systematic Assessment |
| ||
| Vaginal hemorrhage | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Vaginal infection | Infections and infestations | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Wound dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin blistering | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Contact dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Wound pain | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| VAS pain level | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mario Leitao, MD | Memorial Sloan Kettering Cancer Center | 212-639-3987 | leitaom@mskcc.org |
| Oct 22, 2024 |
| Prot_SAP_000.pdf |
| Male |
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| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|