Assessment of a Non-invasive Device in the Management of Open Abdomen (AbCLO)

NCT06242925 | Active Not Recruiting DMC FDA Device

• 1 other identifier: STUDY00003444
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this multicenter, prospective Cohort Interventional study is to perform a pilot study of the AbCLO (Abdominal Wall Closure) device in patients with Open Abdomen. The main question it aims to answer is: • Does the Abdominal Wall Closure Device (AbCLO) increase the likelihood of primary facial closure in cases of open abdomen when compared to historical controls? Participants will be cases of open abdomen who underwent emergency surgery for Trauma or Acute Care Surgery, will have the AbCLO device. These will be compared to historical controls managed at the same center.

Conditions

Open Abdomen

Keywords

Open Abdomen; Trauma; Acute Care Surgery; Emergency General Surgery

Outcome Measures

Primary Outcomes (1)

• Primary Fascial Closure

  Proportion of patients achieved primary facial closure within 14 days. (This is defined as approximation of the fascia on either side of the midline to perform suture closure without using any mesh or additional procedures.

  14 days

Secondary Outcomes (7)

• The need for additional procedure to perform fascial closure

  14 days

• The need for additional device

  14 days

• Duration of open abdomen

  14 days

• Device complications

  14 days

• Duration of mechanical ventilation

  14 days

Study Arms (2)

ABCLO Group

EXPERIMENTAL

The cohort (interventional) patients will receive the standard of care (Lahey bag, Ioban and closed suction drains) in addition to the study intervention (AbCLO Device).

Device: AbCLO (Abdominal Wall Closure) Device

Historical Controls

NO INTERVENTION

The control group is retrospective patients that were previously managed at the same center, regardless of the technique or the device used to close the OA. At TMC, we have a previously collected data bank of all open abdomen managed at our center. This data bank is approved by IRB. This data bank has 170 patients in total. we will use 45 patients from the data bank to be matched to the interventional group (15 patients) to have a total of 60 patients from TMC. As of LAC+USC Medical Center, they will provide historical controls from the trauma registry.

Interventions

AbCLO (Abdominal Wall Closure) Device DEVICE

They will receive the standard of care (Lahey bag covering the bowel, 2 drains in the subcutaneous tissue and Ioban covering everything). The AbClO device has two Rectus Muscle Splints (RMS) to stabilize the rectus abdominis (preventing buckling of these muscles and stabilize the circumferential dynamic retainer (CDR)). The CDR is passed behind the patient's back. The RMSs are positioned on the abdominal wall approximately 2 cm lateral to the wound edges on each side. Additional padding can be applied underneath the RMS. The CDR is passed between the cross bar and the locking strip of each RMS and stretched until taut. The locking strips are locked in position. Four tensioners bridge across the OA from one RMS to the other. Gauze packs should be interposed between the undersurface of the tensioners and the surface of the temporary abdominal coverage to prevent friction. The Tensioners are tightened progressively until complete facial closure.

ABCLO Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults more than 18 years of age, and less than 100 years of age
• Admitted to the trauma and acute care surgery service, underwent damage control laparotomy and left with an open abdomen (OA). Trauma or Emergency General Surgery, such as perforated viscus, Bowel obstruction or abdominal compartment syndrome.

You may not qualify if:

• Pregnant patients
• Patients who lost any portion of the abdominal wall that preclude primary abdominal wall closure
• Patient who previously had a ventral hernia before having an open abdomen
• Patient who already had a previous mesh repair
• Burn patients

Sponsors & Collaborators

• Tufts Medical Center: lead
• InentoRR MD: collaborator
• LAC+USC Medical Center: collaborator

Study Sites (2)

Los Angeles County + University of Sothern California Medical Center

Los Angeles, California, 90033, United States

Location

Tufts Medical center

Boston, Massachusetts, 02111, United States

Location

Related Publications (20)

• Rezende-Neto J, Rice T, Abreu ES, Rotstein O, Rizoli S. Anatomical, physiological, and logistical indications for the open abdomen: a proposal for a new classification system. World J Emerg Surg. 2016 Jun 14;11:28. doi: 10.1186/s13017-016-0083-4. eCollection 2016.

  PMID: 27307788 BACKGROUND

• Roberts DJ, Bobrovitz N, Zygun DA, Ball CG, Kirkpatrick AW, Faris PD, Stelfox HT. Indications for use of damage control surgery and damage control interventions in civilian trauma patients: A scoping review. J Trauma Acute Care Surg. 2015 Jun;78(6):1187-96. doi: 10.1097/TA.0000000000000647.

  PMID: 26151522 BACKGROUND

• Karmali S, Evans D, Laupland KB, Findlay C, Ball CG, Bergeron E, Stewart TC, Parry N, Khetarpal S, Kirkpatrick AW. To close or not to close, that is one of the questions? Perceptions of Trauma Association of Canada surgical members on the management of the open abdomen. J Trauma. 2006 Feb;60(2):287-93. doi: 10.1097/01.ta.0000203579.62446.75.

  PMID: 16508484 BACKGROUND

• Rezende-Neto JB, et al. Vaccum Pack technique for temporary abdominal wound closure. Rev Col Bras Cir 2007; 34:336-339.

  BACKGROUND

• Diaz JJ Jr, Cullinane DC, Dutton WD, Jerome R, Bagdonas R, Bilaniuk JW, Collier BR, Como JJ, Cumming J, Griffen M, Gunter OL, Kirby J, Lottenburg L, Mowery N, Riordan WP Jr, Martin N, Platz J, Stassen N, Winston ES. The management of the open abdomen in trauma and emergency general surgery: part 1-damage control. J Trauma. 2010 Jun;68(6):1425-38. doi: 10.1097/TA.0b013e3181da0da5.

  PMID: 20539186 BACKGROUND

• Chen Y, Ye J, Song W, Chen J, Yuan Y, Ren J. Comparison of Outcomes between Early Fascial Closure and Delayed Abdominal Closure in Patients with Open Abdomen: A Systematic Review and Meta-Analysis. Gastroenterol Res Pract. 2014;2014:784056. doi: 10.1155/2014/784056. Epub 2014 Jun 2.

  PMID: 24987411 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

• Rezende-Neto JB, Rotstein OD. Abdominal catastrophes in the intensive care unit setting. Crit Care Clin. 2013 Oct;29(4):1017-44. doi: 10.1016/j.ccc.2013.06.005. Epub 2013 Aug 16.

  PMID: 24094389 BACKGROUND

• Open Abdomen Advisory Panel; Campbell A, Chang M, Fabian T, Franz M, Kaplan M, Moore F, Reed RL, Scott B, Silverman R. Management of the open abdomen: from initial operation to definitive closure. Am Surg. 2009 Nov;75(11 Suppl):S1-22.

  PMID: 19998714 BACKGROUND

• Kritayakirana K, M Maggio P, Brundage S, Purtill MA, Staudenmayer K, A Spain D. Outcomes and complications of open abdomen technique for managing non-trauma patients. J Emerg Trauma Shock. 2010 Apr;3(2):118-22. doi: 10.4103/0974-2700.62106.

  PMID: 20606786 BACKGROUND

• Sagraves SG, Toschlog EA, Rotondo MF. Damage control surgery--the intensivist's role. J Intensive Care Med. 2006 Jan-Feb;21(1):5-16. doi: 10.1177/0885066605282790.

  PMID: 16698739 BACKGROUND

• Dubose JJ, Lundy JB. Enterocutaneous fistulas in the setting of trauma and critical illness. Clin Colon Rectal Surg. 2010 Sep;23(3):182-9. doi: 10.1055/s-0030-1262986.

  PMID: 21886468 BACKGROUND

• Scott BG, Feanny MA, Hirshberg A. Early definitive closure of the open abdomen: a quiet revolution. Scand J Surg. 2005;94(1):9-14. doi: 10.1177/145749690509400104.

  PMID: 15865109 BACKGROUND

• Smith LA, Barker DE, Chase CW, Somberg LB, Brock WB, Burns RP. Vacuum pack technique of temporary abdominal closure: a four-year experience. Am Surg. 1997 Dec;63(12):1102-7; discussion 1107-8.

  PMID: 9393260 BACKGROUND

• Sherck J, Seiver A, Shatney C, Oakes D, Cobb L. Covering the "open abdomen": a better technique. Am Surg. 1998 Sep;64(9):854-7.

  PMID: 9731813 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

• Dennis A, Vizinas TA, Joseph K, Kingsley S, Bokhari F, Starr F, Poulakidas S, Wiley D, Messer T, Nagy K. Not so fast to skin graft: transabdominal wall traction closes most "domain loss" abdomens in the acute setting. J Trauma Acute Care Surg. 2013 Jun;74(6):1486-92. doi: 10.1097/TA.0b013e3182924950.

  PMID: 23694876 BACKGROUND

• Verdam FJ, Dolmans DE, Loos MJ, Raber MH, de Wit RJ, Charbon JA, Vroemen JP. Delayed primary closure of the septic open abdomen with a dynamic closure system. World J Surg. 2011 Oct;35(10):2348-55. doi: 10.1007/s00268-011-1210-8.

  PMID: 21850603 BACKGROUND

• Rezende-Neto J, Al Kefeiri G, Semprun C, Rizoli S, Rotstein O. A non-invasive device for primary facial closure of the "open Abdomen" to prevent the "homeless bowel": a prospective, randomized, clinical tria abstract]. In: Proceedings of the Trauma Association of Canada 2017 Scientific Meeting & Conference; 2017 Feb 23-24, 2017; Vancouver (AB). Abstract 80.

  BACKGROUND

• Rezende-Neto JB, Camilotti BG. New non-invasive device to promote primary closure of the fascia and prevent loss of domain in the open abdomen: a pilot study. Trauma Surg Acute Care Open. 2020 Nov 11;5(1):e000523. doi: 10.1136/tsaco-2020-000523. eCollection 2020.

  PMID: 33225070 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Mohammed A. Bawazeer, MD

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a multi-center, matched, interventional prospective cohort study compared to historical cohort.

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 5, 2024
• Study Start: February 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)