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 @ 12:55 AM
Ignite Modification Date:
2025-12-25 @ 12:55 AM
NCT ID:
NCT01680367
Eligibility Criteria:
Inclusion Criteria:
* Population of otolaryngological or surgical oncology patients experiencing an autologous split-thickness skin graft as part of their surgical procedure
* Patients will have a Glasgow Coma score of 15 (or 10 with a tracheostomy)
* Patient donor sites will be limited to the anterior thigh
* Patients will be free of documented circulatory deficits, neuropathy, or mental illness which prohibits their ability to independently consent or respond to questions regarding pain
* Patients will be able to give consent independently
* Patients will be able to read and write in English
Exclusion Criteria:
* Patients unable to give independent consent for any reason
* Skin graft donor sites other than the anterior thigh
* Patients with a concurrent diagnosis of diabetes, peripheral vascular disease, and/or paresthesias or paralysis of the lower extremities
* Patients who are unable to complete a self-report pain scale
* Patients who are prisoners
* Patients who are known active alcoholics
* Patients on steroids or other medications known to affect healing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01680367
Study Brief:
Protocol Section:
NCT01680367