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 @ 7:57 PM
Ignite Modification Date:
2025-12-24 @ 7:57 PM
NCT ID:
NCT01062204
Eligibility Criteria:
Inclusion Criteria:
1. Male or female patient is between the ages of 3 and 85 Note: In order to maintain a broad representation of ages, no more than 50% of the patients enrolled in the study should be between the ages of 3 and 16, inclusive.
2. Patient is in general good health
3. Patient has two independent skin donor sites of approximately the same dimensions.
4. Patient is willing and able to cooperate with the protocol for duration of study.
5. Patient is capable of providing informed consent and HIPAA authorization
6. Ability to read and speak either English or Spanish
Exclusion Criteria:
1. Male or female patient is less than 3 years of age or more than 85 years of age
2. Patient has acutely infected wounds
3. Patient has wounds with surrounding cellulites
4. Patient has a history of hypersensitivity to any components of either the nanoparticle or sodium carboxymethylcellulose dressing, or any known sensitivities to other hydrogel bandage treatments
5. Patient has a concurrent clinical condition, which in the judgment of the Investigator could either pose a health risk to the patient while participating in this study, or could potentially influence the outcome of the study;
6. Patient has history of poor wound healing or any skin/immune system condition that would increase likelihood of wound irritation, infection or increase chance of early termination
7. Patient is unable to communicate or to cooperate with the investigator due to language problems, poor mental development, or impaired cerebral function.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
85 Years
Study:
NCT01062204
Study Brief:
Protocol Section:
NCT01062204