Open AbdomenAbCLONCT06242925
Assessment of a Non-invasive Device in the Management of Open Abdomen (AbCLO)
A study testing AbCLO (Abdominal Wall Closure) Device in people with Open Abdomen, run by Tufts Medical Center at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Open Abdomen
- What is being tested?
- AbCLO (Abdominal Wall Closure) Device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2024to 31 Dec 2025
- Phase
- Interventional
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Tufts Medical center
Boston, Massachusetts, 02111
Los Angeles County + University of Sothern California Medical Center
Los Angeles, California, 90033
About this study
Official title: Assessment of a Non-invasive Device in the Management of Open Abdomen (AbCLO)- Pilot Study
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.
Read the detailed description
This is a multi-center matched prospective cohort study. It will be performed in collaboration between 2 centers in the USA: Tufts Medical Center (TMC) and Los Angeles County + University of Southern California (LAC + USC) Medical Center.
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).
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.
The total sample size is 80 patients, 20 in the treatment arm (15 from TMC and 5 from LAC+USC) and 60 in the control arm (45 from TMC and 15 from LAC+USC). The treatment arm will be matched to historical control based on the following pre-specified variables:
- Age
- Diagnosis: trauma case vs acute general surgery cases,
- Assessment of severity: Injury severity scores (ISS) for Trauma cases and APACHEII score for acute general surgery cases
Outcome Data:
- Primary Outcome: 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. From our experience, most open abdomen is usually closed within 7-10 days. We decided to put any closure more than 14 days is considered failure of the device).
- Proportion of patients that require component separation and/or mesh closure to obtain fascial closure, (if we need to use mesh or do additional procedure to close the abdomen, this is considered failure rate of the ABCLO device)
- Percentage of patients requiring additional device, such as Whitman's patch to maintain fascial closure. (this is also considered failure of the ABCLO device)
- The time from inclusion to complete abdominal wall fascial closure (as defined above) prior to discharge. (Duration of patients that require the abdomen to be open)
- Percentage of patients developing pressure ulcers (as a possible complication of the device)
- Duration of mechanical ventilation, ICU length of stay and hospital length of stay (to examine the indirect effects of primary fascial closure on these outcomes)
- Total cost per patient before and after application of the ABCLO from ICU admission to closure of the abdomen.
- Conditions
- Open Abdomen
- Being tested
- AbCLO (Abdominal Wall Closure) Device
- Keywords
- Open Abdomen, Trauma, Acute Care Surgery, Emergency General Surgery
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbCLO (Abdominal Wall Closure) DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 14 days
Secondary outcomes (7)
The need for additional procedure to perform fascial closure
Proportion of patients that require component separation and/or mesh closure to obtain fascial closure
Measured: 14 days
The need for additional device
Percentage of patients requiring additional device, such as Whitman's patch to maintain fascial closure
Measured: 14 days
Duration of open abdomen
The time from inclusion to complete abdominal wall fascial closure (as defined above) prior to discharge.
Measured: 14 days
Device complications
Percentage of patients developing pressure ulcers
Measured: 14 days
Duration of mechanical ventilation
The duration from intubation to liberation off mechanical ventilator.
Measured: 14 days
ICU length of stay and Hospital length of stay
ICU length of stay from admission to leaving the ICU. Hospital length of stay from admission to discharge
Measured: 14 days
cost
Total cost per patient before and after application of the ABCLO from ICU admission to closure of the abdomen
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start1 Feb 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Open AbdomenStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This is a multi-center, matched, interventional prospective cohort study compared to historical cohort.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- InentoRR MD, LAC+USC Medical Center
- Responsible party
- Sponsor
- Investigators
- Mohammed A. Bawazeer, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06242925
- Sponsor's protocol ID
- STUDY00003444
- Acronym
- AbCLO
- Status last verified
- Apr 2025
- First submitted
- 29 Jan 2024
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 27307788Roberts 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.
PubMed 26151522Karmali 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.
PubMed 16508484Rezende-Neto JB, et al. Vaccum Pack technique for temporary abdominal wound closure. Rev Col Bras Cir 2007; 34:336-339.
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.
PubMed 20539186Chen 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.
PubMed 24987411Miller 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.
PubMed 16394910Rezende-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.
PubMed 24094389Open 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.
PubMed 19998714Kritayakirana 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.
PubMed 20606786Sagraves 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.
PubMed 16698739Dubose 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.
PubMed 21886468Scott 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.
PubMed 15865109Smith 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.
PubMed 9393260Sherck J, Seiver A, Shatney C, Oakes D, Cobb L. Covering the "open abdomen": a better technique. Am Surg. 1998 Sep;64(9):854-7.
PubMed 9731813