The REBUILD Trial: Closure of the Abdominal Wall

Launched by ABSOLUTIONS MED INC. · Jan 8, 2023

Keywords

ClinConnect Summary

The REBUILD Trial is studying a device designed to help close the abdominal wall after a surgical procedure called laparotomy, which is a type of surgery that opens the abdomen. The main goal of this trial is to see if the device can safely keep the muscles in the abdomen close together during the healing process. Participants in the trial will have the standard surgery, and then the device will be used to support the stitches that close the abdominal wall. One month after the surgery, participants will have an MRI scan to check how well the muscles are positioned.

To join the study, participants need to be between 22 and 80 years old and scheduled for a midline laparotomy. They must also be able to give their consent to participate and follow the study requirements. However, some people may not be eligible if they have certain medical conditions, a high body weight, or if they are pregnant. The trial is not yet recruiting participants, but it aims to provide important information about the safety and effectiveness of this new device in abdominal surgeries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient is 22-80 years of age
• • 2. Patient is undergoing a midline laparotomy procedure
• • 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 has BMI \> 40
• • 2. Patients with available imaging measuring abdominal wall thickness \< 5.7 mm or \> 16.5 mm
• • 3. Patient is scheduled for a palliative procedure or has a life expectancy of less than 12-months
• • 4. Patient has mesh at the site of deployment
• • 5. Patient has an ostomy within the planned midline closure site (4 cm either side of midline)
• • 6. Patient has a CDC wound classification of Class IV
• • 7. Patient has devitalized tissue present at the intended surgical site
• • 8. Patient has any co-morbid conditions determined by the investigator to place them at a high risk of complications (e.g., severe cardiovascular disease, congestive heart failure NYHA Class III or IV, end-stage renal failure, liver cirrhosis, connective tissue disorder, poorly managed diabetes)
• • 9. Patient is on any medication that the investigator determines creates a high risk for complications (e.g., antithrombotic, steroid, IV chemotherapy, immunosuppressive agent)
• • 10. Patient has history of radiation therapy targeting the abdominal wall
• • 11. Patient is participating in a concurrent investigational medical device study
• • 12. Patient is pregnant or planning on becoming pregnant during the study period
• • 13. Patient has a history of psychological condition, drug, or alcohol misuse which may interfere with their ability to be compliant with post-operative visits