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 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT03948360
Eligibility Criteria:
Inclusion Criteria:
* Patients receiving care at Shriners Hospitals for Children-Boston for a skin tissue injury.
* Patients who have at least one wound with exposed area sufficient, in the Investigator's opinion, to receive LIMB therapy.
* Willing and able to adhere to daily LIMB therapy protocol.
Exclusion Criteria:
* Patients deemed not medically stable by the treating Investigator.
* Patients with clinical signs and symptoms of systemic infection at baseline.
* Patients with burn wounds limited to their head and genitalia.
* Patients who, in the opinion of the Investigator, will not require daily dressing changes.
* Patients receiving photosensitizing agents that result in cutaneous phototoxicity prior to enrollment. Patients who have received one or more of the following photosensitizers cannot be enrolled into the study: photofrin, amiodarone, chloropromazine, fluoroquinolone antibiotics, thiazide diuretics, quinine, demethylchlortetracycline, psoralens, nalidixic acid, tetracycline, naproxen.
* Patients currently enrolled or participating in another investigational device, drug or biological trial within 30 days of the Screening Visit.
* Patients currently receiving any bandages or devices containing silver compounds.
* Patients on a ventilator, who have fluid resuscitation or are in any terminal condition.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
21 Years
Study:
NCT03948360
Study Brief:
Protocol Section:
NCT03948360