Necrotizing PancreatitisNCT04986943
ABTHERA ADVANCE™ Use Without Wittman Patch
An observational study of Necrotizing Pancreatitis, run by Wake Forest University Health Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Necrotizing Pancreatitis
- What is being tested?
- Using ABTHERA Advance without a Wittmann Patch
- Type of treatment
- Medical device
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2020to 14 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Female patients who are pregnant or lactating
- If in the opinion of the treating physician a patient should not participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of the ABTHERA ADVANCE™ Open Abdomen Dressing in Patients With Necrotizing Pancreatitis
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.
Read the detailed 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
- Conditions
- Necrotizing Pancreatitis
- Being tested
- Using ABTHERA Advance without a Wittmann Patch
- Keywords
- Abdominal compartment syndrome, Necrotizing Pancreatitis, Severe sepsis, Necrotizing Pancreatitis with abdominal compartment syndrome, Necrotizing Pancreatitis with severe sepsis
- Medical subject headings
- Pancreatitis, Acute Necrotizing, Intra-Abdominal Hypertension, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using ABTHERA Advance without a Wittmann PatchDevice
In this group, patients will be receiving only the ABTHERA Advance product, without the use of the Wittmann Patch
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Using ABTHERA Advance without a Wittmann Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost Saving
Determine the variable cost savings associated with use of ABTHERA ADVANCE™ without the use of Wittmann patch.
Measured: 3 months after the last participant has been enrolled.
Secondary outcomes (1)
Effectiveness
Determine the rate of abdominal closure, component separation, and mesh placement with the ABTHERA ADVANCE™ without the use of Wittmann patch.
Measured: 3 months after the last participant has been enrolled.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start12 Oct 2020
- Primary completion28 Mar 2022
- Study completion14 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Necrotizing PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Dionisios Vrochides, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04986943
- Sponsor's protocol ID
- IRB00082734
- Other IDs
- 08-20-01A
- Status last verified
- Aug 2023
- First submitted
- 27 Jul 2021
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 23281649Turza 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.
PubMed 23216525Garcia-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.
PubMed 30768066Sermoneta 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.
PubMed 20726923Jensen 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.
PubMed 29085880Kubiak 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.
PubMed 20823698Kirkpatrick 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.
PubMed 25536308Frazee 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.
PubMed 23415556Olona 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.
PubMed 24756917Cheatham 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.
PubMed 23674252Wittmann 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.
PubMed 8098630Bruhin 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.
PubMed 25174789Quyn 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.
PubMed 22487141Atema 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.
PubMed 25446477
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the ABTHERA ADVANCE™ Open Abdomen Dressing in Patients With Necrotizing Pancreatitis
- ClinicalTrials.gov ID
- NCT04986943
- Acronym / sponsor ID
- IRB00082734
- Conditions
- Necrotizing Pancreatitis
- Keywords
- Abdominal compartment syndrome, Necrotizing Pancreatitis, Severe sepsis, Necrotizing Pancreatitis with abdominal compartment syndrome, Necrotizing Pancreatitis with severe sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- 3M
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- 28 Mar 2022 (actual)
- Study completion
- 14 Mar 2023 (actual)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABTHERA Advance without Wittmann patch | – | Device: Using ABTHERA Advance without a Wittmann PatchPatients 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Female patients who are pregnant or lactating
- If in the opinion of the treating physician a patient should not participate in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Using ABTHERA Advance without a Wittmann PatchIn this group, patients will be receiving only the ABTHERA Advance product, without the use of the Wittmann Patch | Device | ABTHERA Advance without Wittmann patch |
Primary outcome
Cost Saving
Time frame: 3 months after the last participant has been enrolled.
Determine the variable cost savings associated with use of ABTHERA ADVANCE™ without the use of Wittmann patch.
1 secondary outcome
Effectiveness
Time frame: 3 months after the last participant has been enrolled.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Background: PubMed 23281649Plaudis 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.
- Background: PubMed 23216525Turza 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.
- Background: PubMed 30768066Garcia-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.
- Background: PubMed 20726923Sermoneta 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.
- Background: PubMed 29085880Jensen 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.
- Background: PubMed 20823698Kubiak 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.
- Background: PubMed 25536308Kirkpatrick 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.
- Background: PubMed 23415556Frazee 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.
- Background: PubMed 24756917Olona 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.
- Background: PubMed 23674252Cheatham 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.
- Background: PubMed 8098630Wittmann 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.
- Background: PubMed 25174789Bruhin 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dionisios Vrochides, MD, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Necrotizing Pancreatitis, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost Saving (time frame: 3 months after the last participant has been enrolled.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04986943, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.