Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03815370 |
| Other study ID # |
17-249 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2019 |
| Est. completion date |
March 30, 2023 |
Study information
| Verified date |
March 2022 |
| Source |
Unity Health Toronto |
| Contact |
Joao Rezende, MD |
| Phone |
416-864-5284 |
| Email |
Rezendenetoj[@]smh.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
At the end of most abdominal operations, the fascial layer is closed by stitching edges of
the wound together. However, because of logistic and/or technical reasons or the patient's
critical condition, the surgeon is forced to leave the abdomen open.
The current approach for temporary coverage of abdomen is vacuum assisted techniques (VAT).
This technique requires the use of vacuum-assisted drainage to remove blood or watery fluid
from a wound or operative site. Although this is the most successful and commonly used
procedure, there are some limitations to this method. For example, VAT have little effect on
preventing lateral movement of the wound edges. Therefore, VAT it is not the ideal procedure
in aiding surgeons to closed the abdomen.
The purpose of this study is to compare usual care (vacuum or non-vacuum methods for
temporary coverage of the OA) versus usual care plus a novel new abdominal binder device
called ABRO™ that may aid in the closure of patients who undergo open abdomen closure
procedures.
Description:
At the end of most abdominal operations the fascial layer is closed primarily. However,
because of logistic, physiological and or anatomical reasons, the surgeon needs to leave the
abdomen open. In those circumstances, attempts to close the abdomen could potentially lead to
unnecessary damage to the abdominal wall fascia, intra-abdominal hypertension, abdominal
compartment syndrome and abdominal wall dehiscence post-operatively.
The use of the "open abdomen" (OA) in the post-operative period is not uncommon. Currently,
three important trends provide grounds for increased use of this surgical strategy:
- Lifesaving surgical procedures in severely injured trauma patients.
- Surgical procedures performed in patients with non-traumatic surgical emergencies
- Abdominal catastrophes in elderly patients with pre-existing medical conditions. The OA
is not a new strategy in the surgeon's armamentarium. A recent publication retrieved
more than 1300 articles over the last 25 years relative to the management of the OA,
published in the English language.5 However, the precise incidence of the OA is unknown.
Nonetheless, hospitals around the world, particularly those that receive trauma victims,
have an OA rate of 1-5% among their most critically ill surgical patients.
This lifesaving surgical strategy does not come without a price. The mortality rate of an OA
is approximately 30%. There is also a wide range of complications linked to this procedure.
The OA exposes large surface area of the body to the environment increasing fluid losses.
Maintenance of adequate fluid and nutritional status of the patient are challenging in this
setting.
Furthermore, the exposed abdominal cavity also poses greater risk for local contamination
from external sources that could ultimately result in sepsis. Impaired abdominal wall
function interferes with ventilatory mechanics. Consequently, patients with OA are prone to
respiratory complications. However, the most dreaded complication of an OA is the formation
of an enteroatmospheric fistula (EF). The incidence of EF is approximately 11-15%, and
increases with time. Patients who have an OA for more than 8 days have an incidence of ECF as
high as 25%, caused mainly by damage to the exposed bowel. Management this complication is
extremely challenging, very costly, and carries a mortality rate of 36-64%.
In consideration of the foregoing considerations, early closure of the OA is undoubtedly the
most effective way to prevent complications linked to this lifesaving surgical strategy. One
of the most important barriers to early closure of the OA is lateral retraction of the
fascial wound edges. Retraction presents as early as three days post-operatively, involves
all layers of the abdominal wall and ultimately results in loss of domain. Moreover,
generalized edema, atrophy and contraction of the abdominal muscles also contribute to a
progressively larger defect in the fascia.Another important problem is "buckling" of the
rectus abdominal muscles resulting in a "diamond" shape defect in the fascial that is very
difficult to close.
Management of the OA prior to definitive closure call for temporary closure techniques. The
three main objectives of temporary closure techniques are to prevent injury to the bowel,
manage fluid loss from the abdominal cavity, and ultimately to facilitate primary closure.
Early closure is dependent on technical factors and patients' underlying clinical condition.
Despite all efforts to facilitate primary fascial closure, this condition is successfully
achieved only in approximately 60% of the cases.
Currently, vacuum assisted techniques (VAT) are the most frequent, and arguably the most
efficacious method for temporary coverage of the OA. Furthermore, VAT are particularly useful
in the management of edema fluid, gastrointestinal and peritoneal secretions. Despite these
important benefits, VAT provide minimal support to prevent lateral retraction of the
abdominal wall fascial edges. Indeed, vacuum closure devices are not able to brace the
abdominal wall and prevent lateralization of the rectus muscles even with maximum negative
pressure. Moreover, excessive negative pressure applied to the abdominal cavity could
potentially provoke severe injury to the intra-abdominal organs and interfere with
physiologic functions.
Devices applied surgically to the abdominal wall are more effective in preventing lateral
retraction of the fascial edges. However, these devices are stitched through the skin,
subcutaneous tissue, muscle, and fascial layers. These stitches frequently cut through the
aforementioned tissues because of the high pressure at the suture sites produced by
counteracting forces. The resulting wounds encompass all layers of the abdominal wall
including the fascia. Another important drawback of devices that require a surgical procedure
for application is the need for frequent trips to operating room for assessment and potential
adjustments. Furthermore, technical limitations inherit to surgically applied temporary
closure devices result in undesirable delay for the initial placement. A recent report showed
that the mean time from the primary operation to placement of the temporary closure device
was 9.5 days.16 This is dangerously close to the critical period of EF formation and loss of
abdominal domain.
Interim analysis of the data obtained from the initial randomized clinical trial to
investigate the original prototype of the non-traumatic binder for abdominal wall closure
(ABROTM) described in this protocol showed promising results (n=20 patients). The utilization
of the original prototype of the ABROTM device resulted in 80% primary fascial closure rate
compared to only 50% when VAT alone was employed. All patients (n=10) subjected to the
application of the original prototype of the ABROTM device had their abdomen closed by
primary fascial suture, without component separation or mesh. The ABROTM prototype resulted
in greater than 65% reduction in the maximum width and the area of the fascial defects at 4 ±
1 days post-operative, whereas VAT alone resulted in a 5% increase. Moreover, interim
analysis of the data showed that there were no complications from the use of the prototype of
the ABROTM device. Therefore, it is anticipated that the use of the new ABROTM device in the
proposed multicentre randomized controlled trial may have several advantages compared to
preexisting methods for closure of the OA
