Fasciotens to Treat an Open Abdomen - a Prospective Cohort Study

NCT04033614 | Recruiting

• 1 other identifier: 18-019
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The open abdomen can occur as a result of various diseases. After infections of the abdomen, compartment syndromes or traumata, it is essential for survival (1). This condition of the open abdomen lasts from days to months. Within a very short time, the fascia and abdominal wall structures retract in such a way that direct abdominal closure is often impossible. In addition, there is a pronounced intraabdominal oedema, which additionally increases the space required by the abdominal organs. Therefore, it is clinically indispensable to increase the space of the intraabdominal organs in this life-threatening situation. After the laparotomy (opening of the abdomen) has been performed, it is therefore not closed. However, the natural traction on the abdominal wall, in particular on the fascia, the attached musculature as well as skin and subcutis, no longer exists in this situation. As a result, these structures retract over the period of the existing laparostoma. In the present study, the CE-certified medical device Fasciotens Abdomen will be used to prove the functionality of this device and the user feasibility. The basic principle of Fasciotens Abdomen is the ventrally directed pulling force on the two fascial edges via an external device with support on the thorax and pelvis. The possibility to apply a traction to the fascia from the moment of opening the abdomen without reducing the intraabdominal space is absolutely new and the rationale of this technique. The objective of this study is to prove the obvious prevention of fascial retraction through the Fasciotens Abdomen device.

Conditions

Abdominal Compartment Syndrome; Pancreatitis,Acute Necrotizing; Intraabdominal Hypertension; Peritonitis

Keywords

Laparotomy, open abdomen, fascia, retraction, intraabdominal oedema

Outcome Measures

Primary Outcomes (1)

• Closure rate of the abdominal wall fascia

  The primary endpoint of the study is the closure rate of the fascia.

  Up to 24 weeks

Study Arms (1)

Patients with Laparostoma

EXPERIMENTAL

Patients needing a laparostoma will be treated with the fasciotens abdomen device. The distance between the fasciae will be measured frequently using a ruler. 12 months after the treatment an ultrasound measurement will be performed to assess hernia formation

Device: Fasciotens-Abdomen

Interventions

Fasciotens-Abdomen DEVICE

The basic principle of Fasciotens Abdomen is the ventrally directed pulling force on the two fascial edges via an external device with support on the thorax and pelvis. A commercially available resorbable surgical mesh is sewn into the fascia margin. Commercial surgical sutures attached to this net are then attached to a height-adjustable suspension, which is connected to an external support on the thorax and pelvis. This ensures continuous traction to the two fascial edges. The remaining wound surface can then be treated with conventional dressing material.

Patients with Laparostoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Laparostoma with a resorbable net and planned or necessary "second look" operation.
• Age of majority
• Signed informed consent form or in the case of patients unable to give consent, signature from the authorised representative/legal carevier or consultant.

You may not qualify if:

• A Moribund patient with a life expectancy of less than 24 hours despite laparostomy
• Unstable thorax or known severe skeletal instability which impaires the use of the fasciotens abdomen device.
• Open wounds or infections at the potential contact points of the Fasciotens abdomen device
• Known cardiac insufficiency with ejection fraction less than 35%
• Patients with lung failure (ARDS) and the need for abdominal positioning within the next 24h
• Persons who are accommodated in a mental hospital or an insititution on official or judicial instruction
• Persons who are dependent on or have an employment relationship with the principal investigator
• Other conditions which, at the judgement of the investigator, militate against the use of the investigational product
• Minority

Sponsors & Collaborators

• RWTH Aachen University: lead
• Fasciotens GmbH: collaborator

Study Sites (1)

Klinik für Allgemein-, Viszeral- und Transplantationschirurgie

Aachen, North Rhine-Westphalia, 52074, Germany

RECRUITING

Related Publications (16)

• 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.

  PMID: 25174789 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.

  PMID: 22487141 BACKGROUND

• Roberts DJ, Zygun DA, Grendar J, Ball CG, Robertson HL, Ouellet JF, Cheatham ML, Kirkpatrick AW. Negative-pressure wound therapy for critically ill adults with open abdominal wounds: a systematic review. J Trauma Acute Care Surg. 2012 Sep;73(3):629-39. doi: 10.1097/TA.0b013e31825c130e.

  PMID: 22929494 BACKGROUND

• Carlson GL, Patrick H, Amin AI, McPherson G, MacLennan G, Afolabi E, Mowatt G, Campbell B. Management of the open abdomen: a national study of clinical outcome and safety of negative pressure wound therapy. Ann Surg. 2013 Jun;257(6):1154-9. doi: 10.1097/SLA.0b013e31828b8bc8.

  PMID: 23478532 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.

  PMID: 23674252 BACKGROUND

• Cheatham ML, Safcsak K. Is the evolving management of intra-abdominal hypertension and abdominal compartment syndrome improving survival? Crit Care Med. 2010 Feb;38(2):402-7. doi: 10.1097/ccm.0b013e3181b9e9b1.

  PMID: 20095067 BACKGROUND

• Miller RS, Morris JA Jr, Diaz JJ Jr, Herring MB, May AK. Complications after 344 damage-control open celiotomies. J Trauma. 2005 Dec;59(6):1365-71; discussion 1371-4. doi: 10.1097/01.ta.0000196004.49422.af.

  PMID: 16394910 BACKGROUND

• Vidal MG, Ruiz Weisser J, Gonzalez F, Toro MA, Loudet C, Balasini C, Canales H, Reina R, Estenssoro E. Incidence and clinical effects of intra-abdominal hypertension in critically ill patients. Crit Care Med. 2008 Jun;36(6):1823-31. doi: 10.1097/CCM.0b013e31817c7a4d.

  PMID: 18520642 BACKGROUND

• Raeburn CD, Moore EE, Biffl WL, Johnson JL, Meldrum DR, Offner PJ, Franciose RJ, Burch JM. The abdominal compartment syndrome is a morbid complication of postinjury damage control surgery. Am J Surg. 2001 Dec;182(6):542-6. doi: 10.1016/s0002-9610(01)00821-2.

  PMID: 11839314 BACKGROUND

• Barker DE, Kaufman HJ, Smith LA, Ciraulo DL, Richart CL, Burns RP. Vacuum pack technique of temporary abdominal closure: a 7-year experience with 112 patients. J Trauma. 2000 Feb;48(2):201-6; discussion 206-7. doi: 10.1097/00005373-200002000-00001.

  PMID: 10697075 BACKGROUND

• Bee TK, Croce MA, Magnotti LJ, Zarzaur BL, Maish GO 3rd, Minard G, Schroeppel TJ, Fabian TC. Temporary abdominal closure techniques: a prospective randomized trial comparing polyglactin 910 mesh and vacuum-assisted closure. J Trauma. 2008 Aug;65(2):337-42; discussion 342-4. doi: 10.1097/TA.0b013e31817fa451.

  PMID: 18695468 BACKGROUND

• De Waele JJ, Leppaniemi AK. Temporary abdominal closure techniques. Am Surg. 2011 Jul;77 Suppl 1:S46-50.

  PMID: 21944452 BACKGROUND

• Hatch QM, Osterhout LM, Podbielski J, Kozar RA, Wade CE, Holcomb JB, Cotton BA. Impact of closure at the first take back: complication burden and potential overutilization of damage control laparotomy. J Trauma. 2011 Dec;71(6):1503-11. doi: 10.1097/TA.0b013e31823cd78d.

  PMID: 22182860 BACKGROUND

• Burlew CC, Moore EE, Biffl WL, Bensard DD, Johnson JL, Barnett CC. One hundred percent fascial approximation can be achieved in the postinjury open abdomen with a sequential closure protocol. J Trauma Acute Care Surg. 2012 Jan;72(1):235-41. doi: 10.1097/TA.0b013e318236b319.

  PMID: 22310132 BACKGROUND

• Dubose JJ, Scalea TM, Holcomb JB, Shrestha B, Okoye O, Inaba K, Bee TK, Fabian TC, Whelan J, Ivatury RR; AAST Open Abdomen Study Group. Open abdominal management after damage-control laparotomy for trauma: a prospective observational American Association for the Surgery of Trauma multicenter study. J Trauma Acute Care Surg. 2013 Jan;74(1):113-20; discussion 1120-2. doi: 10.1097/TA.0b013e31827891ce.

  PMID: 23271085 BACKGROUND

• Lambertz A, Mihatsch C, Roth A, Kalverkamp S, Eickhoff R, Neumann UP, Klink CD, Junge K. Fascial closure after open abdomen: initial indication and early revisions are decisive factors--a retrospective cohort study. Int J Surg. 2015 Jan;13:12-16. doi: 10.1016/j.ijsu.2014.11.025. Epub 2014 Nov 25.

  PMID: 25447607 BACKGROUND

MeSH Terms

Conditions

Intra-Abdominal Hypertension; Pancreatitis, Acute Necrotizing; Peritonitis

Condition Hierarchy (Ancestors)

Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Intraabdominal Infections; Infections; Peritoneal Diseases

Central Study Contacts

Roman Marius Eickhoff, Dr. med.

CONTACT

+49 241 80 89500; reickhoff@ukaachen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist in surgery

Study Record Dates

• First Submitted: July 18, 2019
• First Posted: July 26, 2019
• Study Start: August 5, 2019
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)