Clinical trial NCT05041530: Abdominal Wall Closure After Laparotomy in Oncologic Surgery
Official title: A Prospective, Multi-Center, Single Arm, Feasibility Study Using REBUILD Bioabsorbable™ for Closure of the Abdominal Wall After Oncologic Laparotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Laparotomy
Keywords: Laparotomy
Abdominal Wall Closure
Lead sponsor: AbSolutions Med Inc.
Sponsor class: INDUSTRY
Collaborators: name: Cogent Technologies Corporation
First posted: 2021-09-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multi-center, single-arm, feasibility study
Primary purpose: TREATMENT

Brief summary: The REBUILD Study is a first-in-human evaluation of the safety and performance of REBUILD Bioabsorbable.

Detailed description: REBUILD is an investigational medical device designed to be used with third-party suture to distribute suture tension in abdominal wall closures. In this study, REBUILD will be used in oncology patients undergoing an open, elective, intent-to-cure, laparotomy procedure. The study is a prospective, non-randomized, multi-center study designed to generate descriptive data about the use of REBUILD. The primary safety outcome is reported device-related adverse events. The primary performance outcome is the integrity of the abdominal wall over one year assessed by clinical examination of the abdomen. If available, CT studies performed within 12 months post-procedure will be used to confirm apposition of the medial border of the rectus muscles and integrity of the abdominal wall.

Eligibility criteria: Inclusion Criteria:

1. Patient is 18-75 years of age
2. Patient is scheduled for oncologic, open, elective, intent-to-cure laparotomy
3. Patient is able to provide written informed consent
4. Patient is able and willing to comply with all study requirements

Exclusion Criteria:

1. Patient is scheduled for a palliative procedure
2. Patient has had previous failed surgical repair of a ventral or incisional hernia
3. Patient has a current infection at the intended surgical site
4. Patient is participating in a concurrent investigational medical device study
5. Patient is pregnant or planning on becoming pregnant during the study period
6. Patient has a history of psychological condition, drug or alcohol misuse which may interfere with their ability to be compliant with post-operative visits.

Primary outcomes:
measure: Adverse Events
timeFrame: 12 months
measure: Performance
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Medellín
country: Colombia
facility: Clinica Medellin
state: Antioquia
city: Medellin
country: Colombia
facility: Clinica Las Americas
Study officials:
affiliation: Clinica Las Americas
name: Luis J Palacios Fuenmayor, MD
role: PRINCIPAL_INVESTIGATOR
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