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 @ 1:41 AM
Ignite Modification Date:
2025-12-25 @ 1:41 AM
NCT ID:
NCT05093894
Eligibility Criteria:
Inclusion Criteria:
* Men and women over 18 years of age
* Patients undergoing open hernia repair with retromuscular or preperitoneal placement of polypropylene mesh in clean (Class I) operative fields, and who are candidates for complete skin closure
* Capable and willing to attend the scheduled postoperative visits
* Signed ICF for study enrollment
Exclusion Criteria:
* Prisoners
* Minimally invasive repairs (laparoscopy, robotics)
* CDC Wound Class II-IV
* Irrigation of the wound or peritoneal cavity with antibiotic or antimicrobial fluid
* Inability to completely close the midline fascia
* Mesh placed as a bridge, onlay, or intraperitoneal position to the fascia
* Skin left open or packed at the time of the index operation
* Use of wound wicks at the time of the index operation
* Use of an investigational product within the preceding 60 days
* Allergy to silver
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05093894
Study Brief:
Protocol Section:
NCT05093894