ABTHERA ADVANCE™ Use Without Wittman Patch

Necrotizing Pancreatitis Clinical Trial

Official title:

Use of the ABTHERA ADVANCE™ Open Abdomen Dressing in Patients With Necrotizing Pancreatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04986943
• Other study ID #: IRB00082734
• Secondary ID: 08-20-01A
• Status: Completed
• Start date: October 12, 2020
• Est. completion date: March 14, 2023

Study information

• Verified date: August 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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 ADVANCE™ 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 ADVANCE™ 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: March 14, 2023
• Est. primary completion date: March 28, 2022
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Male or Female patients aged = 22

• Severe necrotizing pancreatitis with abdominal compartment syndrome or severe sepsis requiring decompressive laparotomy and/or pancreatic debridement

• Patients that require open abdomen at the conclusion of their index operation

Exclusion Criteria:

• Female patients who are pregnant or lactating

• If in the opinion of the treating physician a patient should not participate in this study.

Related Conditions & MeSH terms

• Necrotizing Pancreatitis
• Pancreatitis
• Pancreatitis, Acute Necrotizing

Intervention

Device:
• Using ABTHERA Advance without a Wittmann Patch
In this group, patients will be receiving only the ABTHERA Advance product, without the use of the Wittmann Patch

Locations

Country	Name	City	State
United States	Atrium Health	Charlotte	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	3M

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cost Saving	Determine the variable cost savings associated with use of ABTHERA ADVANCE™ without the use of Wittmann patch.	3 months after the last participant has been enrolled.
Secondary	Effectiveness	Determine the rate of abdominal closure, component separation, and mesh placement with the ABTHERA ADVANCE™ without the use of Wittmann patch.	3 months after the last participant has been enrolled.