Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:41 PM
Ignite Modification Date:
2025-12-24 @ 12:41 PM
NCT ID:
NCT03703661
Eligibility Criteria:
Inclusion Criteria:
* at least 18 years of age
* presence of a loop or end colostomy or ileostomy
* consenting to study and to ostomy reversal
Exclusion Criteria:
* altered mental status or patients unable to sign the informed consent form
* vulnerable patient populations such as prison and ward patients
* patients who are discovered before or during surgery as unable to undergo placement of compression dressing will be excluded.
* Patients with visible protrusion/evidence of large parastomal hernia
* history of recurrent skin \& soft tissue infections
* history of previous stoma site infection or complications
* patients with extensive comorbidities (such as cancer involving stoma site, uncontrolled diabetes, etc), Crohn's patients and abdominal wall fistula patients
* patients in who primary closure of wound is deemed inappropriate by the operating surgeon, requiring a different method of stoma site wound management
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03703661
Study Brief:
Protocol Section:
NCT03703661