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:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-25 @ 1:24 AM
NCT ID:
NCT03816293
Eligibility Criteria:
Inclusion Criteria: Category A and B
A. Patients undergoing any of the below procedures:
1. C-section
2. abdominal hysterectomy
3. colon procedures Surgical procedures selected will be based on NHSN designated ICD-10 PCS codes(14), with the exclusion of laparoscopic procedures.
B. and either of the following medical conditions:
1. obesity, BMI \>30 kg/m2
2. diabetes type 1 or 2 Criteria for a diagnosis of diabetes: Diabetes noted in the problem list or the medical history or Patient is taking a medication as treatment for diabetes, consistent with NHSN criteria(10).
Exclusion Criteria:
1. Age less than 18 years
2. Infection present at the time of the surgery
3. Laparoscopic procedures with incisions \<6cm.
4. Patients using alternative NPWT device other than the PrevenaTM with 125 mm Hg negative pressure
5. Prisoners
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03816293
Study Brief:
Protocol Section:
NCT03816293