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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT01359735
Eligibility Criteria:
Inclusion Criteria:
* Provide informed consent.
* Age ≥ 18 years and of either sex.
* Type I, II, or III skin as assessed by the Fitzpatrick Scale.
* Willing to comply with protocol instructions, including allowing all study assessments.
* Scheduled to have head or neck non-melanoma skin cancers removed by Mohs micrographic surgery with final wound size of 8 mm to 20 mm in diameter or with 8 mm to 20 mm long axis if not circular.
* Acceptable state of health and nutrition, in the opinion of the Investigator.
Exclusion Criteria:
* History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, or amphotericin B.
* Therapy with blood-thinning agents including aspirin within 14 days of the Baseline Visit (these may be resumed post-surgery).
* Subjects with platelet or coagulation disorders.
* Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
* Current systemic therapy with cytotoxic drugs.
* Current therapy with chronic (\> 10 days) oral corticosteroids.
* In the opinion of the Investigator the subject has a current life expectancy of less than 1 year.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01359735
Study Brief:
Protocol Section:
NCT01359735