Abdominal wall closure after open cancer surgery using a bioabsorbable device

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, prospective, non-randomized study involving multiple centers to describe how REBUILD performs when used with standard sutures during open oncologic laparotomies. The primary safety measure is device-related adverse events within the study period, and the primary performance measure is the integrity of the abdominal wall at one year based on physical exams, with CT confirmation if available. The study focuses on descriptive data to characterize safety and how well the device helps maintain closure. Eligible participants are adults 18-75 undergoing planned open oncologic laparotomy and able to consent and comply with follow-up visits.

Why it matters

Who can join: the full rules

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.

Where it's running

• Clinica Medellin
  Medellín, Antioquia, Colombia Recruiting
• Clinica Las Americas
  Medellín, Colombia Recruiting

Study contacts

• Principal investigator: Luis J Palacios Fuenmayor, MD — Clinica Las Americas
• Study coordinator: Daniel Jacobs, MD
• Email: danj@absolutionsmed.com
• Phone: 650-303-6140

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.