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| ID | Type | Description | Link |
|---|---|---|---|
| 08-20-01A | Other Identifier | Atrium |
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| Name | Class |
|---|---|
| 3M | INDUSTRY |
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The objective of this study is to evaluate the use of the ABTHERA ADVANCE for patients requiring open abdomen due to necrotizing pancreatitis. The institutions traditional approach is to use the ABTHERA Open Abdomen dressing with Wittmann patch. However, the ABTHERA ADVANCE has shown in vitro to have improved tension on the abdominal wall that may obviate the need for costly Wittmann patch placement.
The objective of this study is to evaluate the use of the ABTHERA ADVANCE for patients requiring open abdomen due to necrotizing pancreatitis. The instiutions traditional approach is to use the ABTHERA Open Abdomen dressing with Wittmann patch. However, the ABTHERA ADVANCE has shown in vivotro to have improved fascia movement that may obviate the need for costly Wittmann patch placement.
Primary Objective: Determine the variable cost savings associated with use of ABTHERA ADVANCEâ„¢ without the use of Wittmann patch Hypothesis: The hypothesis is that with use of the ABTHERA ADVANCE will lead to reduced variable costs compared to ABTHERA Open Abdomen dressing with Wittmann patch Secondary Objective(s): Determine the rate of abdominal closure, component separation, and mesh placement with the ABTHERA ADVANCEâ„¢ without the use of Wittmann patch Hypothesis: The hypothesis is that rate of abdominal closure, component separation, and mesh placement will appear similar with use of ABTHERA ADVANCE compared to ABTHERA Open Abdomen dressing with Wittmann patch
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABTHERA Advance without Wittmann patch | Patients with necrotizing pancreatitis that require an open abdomen after their initial operation will be treated with ABTHERA ADVANCE only, without the use of Wittmann patch. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Using ABTHERA Advance without a Wittmann Patch | Device | In this group, patients will be receiving only the ABTHERA Advance product, without the use of the Wittmann Patch |
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| Measure | Description | Time Frame |
|---|---|---|
| Cost Saving | Determine the variable cost savings associated with use of ABTHERA ADVANCEâ„¢ without the use of Wittmann patch. | 3 months after the last participant has been enrolled. |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness | Determine the rate of abdominal closure, component separation, and mesh placement with the ABTHERA ADVANCEâ„¢ without the use of Wittmann patch. | 3 months after the last participant has been enrolled. |
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Inclusion Criteria:
Exclusion Criteria:
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The target study population is patients with necrotizing pancreatitis that require an open abdomen. Pancreatitis is a wide spectrum of disease, however patients with necrotizing pancreatitis are a relatively small subset. As a quaternary care center for patients with pancreatic diseases, most patients in Atrium's care network with severe necrotizing pancreatitis are referred to Carolinas Medical Center. The patients that will be approached for this study are those in the intensive care unit that develop abdominal compartment syndrome or severe pancreatitis requiring laparotomy. The goal for patient enrollment will be 20 patients and outcomes for these patients will be compared to a historical cohort of 40 patients.
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| Name | Affiliation | Role |
|---|---|---|
| Dionisios Vrochides, MD, PhD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atrium Health | Charlotte | North Carolina | 28204 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23281649 | Background | Plaudis H, Rudzats A, Melberga L, Kazaka I, Suba O, Pupelis G. Abdominal negative-pressure therapy: a new method in countering abdominal compartment and peritonitis - prospective study and critical review of literature. Ann Intensive Care. 2012 Dec 20;2 Suppl 1(Suppl 1):S23. doi: 10.1186/2110-5820-2-S1-S23. Epub 2012 Dec 20. | |
| 23216525 |
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| ID | Term |
|---|---|
| D019283 | Pancreatitis, Acute Necrotizing |
| D059325 | Intra-Abdominal Hypertension |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D003161 | Compartment Syndromes |
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| Turza KC, Campbell CA, Rosenberger LH, Politano AD, Davies SW, Riccio LM, Sawyer RG. Options for closure of the infected abdomen. Surg Infect (Larchmt). 2012 Dec;13(6):343-51. doi: 10.1089/sur.2012.014. Epub 2012 Dec 10. |
| 30768066 | Background | Garcia-Corral JR, Cardenas-Lailson LE, Sanjuan-Martinez CA, Arellano-Solorio CH, Aquino-Matus JE, Carrillo-Romero A. Negative pressure therapy in combination with mesh-mediated fascial traction in the treatment of infected pancreatic necrosis. A new therapeutic option. Cir Cir. 2019;87(2):219-223. doi: 10.24875/CIRU.18000472. |
| 20726923 | Background | Sermoneta D, Di Mugno M, Spada PL, Lodoli C, Carvelli ME, Magalini SC, Cavicchioni C, Bocci MG, Martorelli F, Brizi MG, Gui D. Intra-abdominal vacuum-assisted closure (VAC) after necrosectomy for acute necrotising pancreatitis: preliminary experience. Int Wound J. 2010 Dec;7(6):525-30. doi: 10.1111/j.1742-481X.2010.00727.x. Epub 2010 Aug 19. |
| 29085880 | Background | Jensen RO, Buchbjerg T, Simonsen RM, Eckardt R, Qvist N. Vacuum-Assisted Abdominal Closure Is Safe and Effective: A Cohort Study in 74 Consecutive Patients. Surg Res Pract. 2017;2017:7845963. doi: 10.1155/2017/7845963. Epub 2017 Sep 11. |
| 20823698 | Background | Kubiak BD, Albert SP, Gatto LA, Snyder KP, Maier KG, Vieau CJ, Roy S, Nieman GF. Peritoneal negative pressure therapy prevents multiple organ injury in a chronic porcine sepsis and ischemia/reperfusion model. Shock. 2010 Nov;34(5):525-34. doi: 10.1097/SHK.0b013e3181e14cd2. |
| 25536308 | Background | Kirkpatrick AW, Roberts DJ, Faris PD, Ball CG, Kubes P, Tiruta C, Xiao Z, Holodinsky JK, McBeth PB, Doig CJ, Jenne CN. Active Negative Pressure Peritoneal Therapy After Abbreviated Laparotomy: The Intraperitoneal Vacuum Randomized Controlled Trial. Ann Surg. 2015 Jul;262(1):38-46. doi: 10.1097/SLA.0000000000001095. |
| 23415556 | Background | Frazee RC, Abernathy SW, Jupiter DC, Hendricks JC, Davis M, Regner JL, Isbell T, Smith RW, Smythe WR. Are commercial negative pressure systems worth the cost in open abdomen management? J Am Coll Surg. 2013 Apr;216(4):730-3; discussion 733-5. doi: 10.1016/j.jamcollsurg.2012.12.035. Epub 2013 Feb 13. |
| 24756917 | Background | Olona C, Caro A, Duque E, Moreno F, Vadillo J, Rueda JC, Vicente V. Comparative study of open abdomen treatment: ABThera vs. abdominal dressing. Hernia. 2015 Apr;19(2):323-8. doi: 10.1007/s10029-014-1253-5. Epub 2014 Apr 23. |
| 23674252 | Background | Cheatham ML, Demetriades D, Fabian TC, Kaplan MJ, Miles WS, Schreiber MA, Holcomb JB, Bochicchio G, Sarani B, Rotondo MF. Prospective study examining clinical outcomes associated with a negative pressure wound therapy system and Barker's vacuum packing technique. World J Surg. 2013 Sep;37(9):2018-30. doi: 10.1007/s00268-013-2080-z. |
| 8098630 | Background | Wittmann DH, Aprahamian C, Bergstein JM, Edmiston CE, Frantzides CT, Quebbeman EJ, Condon RE. A burr-like device to facilitate temporary abdominal closure in planned multiple laparotomies. Eur J Surg. 1993 Feb;159(2):75-9. |
| 25174789 | Background | Bruhin A, Ferreira F, Chariker M, Smith J, Runkel N. Systematic review and evidence based recommendations for the use of negative pressure wound therapy in the open abdomen. Int J Surg. 2014 Oct;12(10):1105-14. doi: 10.1016/j.ijsu.2014.08.396. Epub 2014 Aug 28. |
| 22487141 | Background | Quyn AJ, Johnston C, Hall D, Chambers A, Arapova N, Ogston S, Amin AI. The open abdomen and temporary abdominal closure systems--historical evolution and systematic review. Colorectal Dis. 2012 Aug;14(8):e429-38. doi: 10.1111/j.1463-1318.2012.03045.x. |
| 25446477 | Background | Atema JJ, Gans SL, Boermeester MA. Systematic review and meta-analysis of the open abdomen and temporary abdominal closure techniques in non-trauma patients. World J Surg. 2015 Apr;39(4):912-25. doi: 10.1007/s00268-014-2883-6. |
| D009135 |
| Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |