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 @ 2:58 PM
Ignite Modification Date:
2025-12-24 @ 2:58 PM
NCT ID:
NCT01126359
Eligibility Criteria:
Inclusion Criteria:
1. wounds to which a split-thickness autologous skin graft applied;
2. infected wounds after debridement;
3. open fracture wounds;
4. acute soft-tissue wounds (with exposed tendon, bone, hardware, and/or joint);
5. fasciotomy wounds after compartment syndrome;
6. chronic non-healing wounds;
7. surgical wounds that are difficult to close due to tension; or
8. wounds with external fixation pins or tubes with irritation or drainage.
Exclusion Criteria:
1. allergy to lidocaine;
2. allergy to the polyurethane foam or impermeable seal;
3. malignancy associated with the wound;
4. extremity insensate to pain due to any cause (including diabetic neuropathy, or any neurologic disorder therein);
5. pregnancy as diagnosed by urine pregnancy test.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01126359
Study Brief:
Protocol Section:
NCT01126359