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| Name | Class |
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| Acelity | OTHER |
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This study is a prospective, multi-center, two-arm, unblinded, and randomized controlled trial with a goal of evaluating the impact of a closed incision negative pressure dressing (PREVENA) on incidence of post-operative wound complications and medical costs in patients undergoing lower extremity amputation.
This is a prospective, multi-center, two-arm, unblinded, randomized controlled trial to evaluate the impact of a closed incision negative pressure dressing (PREVENA™ PEEL & PLACE™ Dressing Kit) on incidence of post-operative wound complications in patients undergoing above-the-knee (AKA) or below-the-knee (BKA) amputation. Up to 440 subjects at approximately five (5) participating sites will be randomized to receive either the Prevena dressing or a standard care dressing. The incision will be assessed for complications at post-op day 5 or day 6 and at approximately 30 days after discharge. The primary outcome of this study is reported wound complications, including dehiscence (opening of the incision), seroma, lymph leak, infection (deep or superficial), hematoma (blood clots), ischemia (decreased blood supply), and necrosis (tissue death) A major complication is defined as any wound complication requiring intravenous or oral antibiotics, reoperation and/or hospital readmission. All data (demographics, medical history, and clinical outcomes) will be collected via medical record review
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevena | Experimental | PREVENA™ PEEL & PLACE™ Dressing Kit |
|
| Standard Care | No Intervention | sterile gauze dressing supplemented with an Ace wrap |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PREVENA™ PEEL & PLACE™ Dressing Kit | Device | In combination with a negative pressure pump (V.A.C. ® Therapy Unit, KCI USA, Inc.), the Prevena dressing is designed to provide negative pressure wound therapy (NPWT) over surgical incisions (incisional NPWT). |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Rate of Wound Complications | Presence of any of the following post-procedure:
| 30 days post procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Stay (LOS) | index LOS is defined as days from operation to discharge; 30d LOS is defined as the index LOS plus all readmission days within 30d related to any wound complication | 30 days post procedure |
| 30-day Return to Operating Room (ROR) |
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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 |
|---|---|---|---|---|---|---|
| Westchester Medical Center | Valhalla | New York | 10595 | United States | ||
| Thomas Jefferson University/Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21840153 | Background | Hasanadka R, McLafferty RB, Moore CJ, Hood DB, Ramsey DE, Hodgson KJ. Predictors of wound complications following major amputation for critical limb ischemia. J Vasc Surg. 2011 Nov;54(5):1374-82. doi: 10.1016/j.jvs.2011.04.048. Epub 2011 Aug 15. | |
| 21723151 | Background | Belmont PJ Jr, Davey S, Orr JD, Ochoa LM, Bader JO, Schoenfeld AJ. Risk factors for 30-day postoperative complications and mortality after below-knee amputation: a study of 2,911 patients from the national surgical quality improvement program. J Am Coll Surg. 2011 Sep;213(3):370-8. doi: 10.1016/j.jamcollsurg.2011.05.019. Epub 2011 Jul 1. |
| Label | URL |
|---|---|
| National Healthcare Safety Network definition of Surgical Site Infection (SSI) Event | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prevena | PREVENA™ PEEL & PLACE™ Dressing Kit |
| FG001 | Standard Care | sterile gauze dressing supplemented with an Ace wrap |
| 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 | Aug 21, 2018 |
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Reoperation for wound complication within 30 days involving incision and drainage in the operating room; opening the skin to drain a superficial soft tissue infection at bedside or in the office is not considered reoperation
| 30 days post procedure |
| 30-day Hospital Readmissions | Rehospitalization for wound complication within 30 days | 30 days post procedure |
| Incidence of Skin Dehiscence | Individual rates of the incidence of skin dehiscence | 30 days post procedure |
| Incidence of Fascial Dehiscence | Individual incidence rate of fascial dehiscence | 30 Days |
| Incidence of Superficial Skin Infection | Individual incidence of superficial skin infection | 30 days |
| Incidence of Deep Skin Infection | Individual incidence of deep skin infection | 30 days |
| Incidence of Seroma | Individual incidence of seroma | 30 Days |
| Incidence of Hematoma | Individual Incidence of Hematoma | 30 days |
| Incidence of Necrosis | Individual incidence of Necrosis | 30 Days |
| Philadelphia |
| Pennsylvania |
| 19107 |
| United States |
| Gemelli Hospital | Roma | RM | 8, 00168 | Italy |
| 21804414 | Background | Stannard JP, Volgas DA, McGwin G 3rd, Stewart RL, Obremskey W, Moore T, Anglen JO. Incisional negative pressure wound therapy after high-risk lower extremity fractures. J Orthop Trauma. 2012 Jan;26(1):37-42. doi: 10.1097/BOT.0b013e318216b1e5. |
| 21761149 | Background | Pachowsky M, Gusinde J, Klein A, Lehrl S, Schulz-Drost S, Schlechtweg P, Pauser J, Gelse K, Brem MH. Negative pressure wound therapy to prevent seromas and treat surgical incisions after total hip arthroplasty. Int Orthop. 2012 Apr;36(4):719-22. doi: 10.1007/s00264-011-1321-8. Epub 2011 Jul 15. |
| 23111014 | Background | Grauhan O, Navasardyan A, Hofmann M, Muller P, Stein J, Hetzer R. Prevention of poststernotomy wound infections in obese patients by negative pressure wound therapy. J Thorac Cardiovasc Surg. 2013 May;145(5):1387-92. doi: 10.1016/j.jtcvs.2012.09.040. Epub 2012 Oct 27. |
| 26994715 | Background | Hyldig N, Birke-Sorensen H, Kruse M, Vinter C, Joergensen JS, Sorensen JA, Mogensen O, Lamont RF, Bille C. Meta-analysis of negative-pressure wound therapy for closed surgical incisions. Br J Surg. 2016 Apr;103(5):477-86. doi: 10.1002/bjs.10084. |
| 30126781 | Background | 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. |
| 497341 | Background | O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549-56. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Prevena | PREVENA™ PEEL & PLACE™ Dressing Kit |
| BG001 | Standard Care | sterile gauze dressing supplemented with an Ace wrap |
| BG002 | 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, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | 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 | Overall Rate of Wound Complications | Presence of any of the following post-procedure:
| Posted | Count of Participants | Participants | 30 days post procedure |
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| Secondary | Length of Stay (LOS) | index LOS is defined as days from operation to discharge; 30d LOS is defined as the index LOS plus all readmission days within 30d related to any wound complication | Posted | Mean | Standard Deviation | Length of stay in days | 30 days post procedure |
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| Secondary | 30-day Return to Operating Room (ROR) | Reoperation for wound complication within 30 days involving incision and drainage in the operating room; opening the skin to drain a superficial soft tissue infection at bedside or in the office is not considered reoperation | Posted | Count of Participants | Participants | 30 days post procedure |
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| Secondary | 30-day Hospital Readmissions | Rehospitalization for wound complication within 30 days | Posted | Count of Participants | Participants | 30 days post procedure |
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| Secondary | Incidence of Skin Dehiscence | Individual rates of the incidence of skin dehiscence | Posted | Count of Participants | Participants | 30 days post procedure |
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| Secondary | Incidence of Fascial Dehiscence | Individual incidence rate of fascial dehiscence | Posted | Count of Participants | Participants | 30 Days |
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| Secondary | Incidence of Superficial Skin Infection | Individual incidence of superficial skin infection | Posted | Count of Participants | Participants | 30 days |
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| Secondary | Incidence of Deep Skin Infection | Individual incidence of deep skin infection | Posted | Count of Participants | Participants | 30 days |
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| Secondary | Incidence of Seroma | Individual incidence of seroma | Posted | Count of Participants | Participants | 30 Days |
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| Secondary | Incidence of Hematoma | Individual Incidence of Hematoma | Posted | Count of Participants | Participants | 30 days |
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| Secondary | Incidence of Necrosis | Individual incidence of Necrosis | Posted | Count of Participants | Participants | 30 Days |
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30 days following hospitalization for amputation
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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 | Prevena | PREVENA™ PEEL & PLACE™ Dressing Kit | 1 | 134 | 11 | 134 | 0 | 134 |
| EG001 | Standard Care | sterile gauze dressing supplemented with an Ace wrap | 1 | 129 | 14 | 129 | 0 | 129 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sepsis | Immune system disorders | Systematic Assessment |
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| Skin Dehiscence | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Gastrointestinal Hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Delayed Wound Healing | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Hematoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Homorrhage from Operative Site | Vascular disorders | Non-systematic Assessment |
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| Interstitial Lung Disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Loose Staple | Product Issues | Non-systematic Assessment | Loose staple after trauma to surgical site |
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| Osteomyelitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Worsening post-procedure pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Angina | Cardiac disorders | Non-systematic Assessment |
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| Acute respiratory Distress | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Soft Tissue Infection | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| STEMI | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul DiMuzio, MD | Thomas Jefferson University | 215-955-8304 | paul.dimuzio@jefferson.edu |
| Nov 30, 2018 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D049291 | Seroma |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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