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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07316192
Eligibility Criteria:
Inclusion Criteria:
* Adults (≥18 years) with a confirmed clinical diagnosis of HS requiring wide surgical excision.
* Ability to provide informed consent in English.
* Willingness and ability to attend routine postoperative follow-up visits to monitor healing and readiness for second-stage closure.
Exclusion Criteria:
* Non-English-speaking patients (due to consent and follow-up communication limitations).
* Known allergy or hypersensitivity to wound matrix components (polyvinyl alcohol), local anesthetics, or silver.
* Known sensitivity to lidocaine or history of cardiac conditions contraindicating lidocaine use (e.g., severe heart block, Adams-Stokes syndrome, Wolff-Parkinson-White syndrome).
* Pregnancy or active breastfeeding.
* Severe immunosuppression (e.g., chemotherapy within 3 months, solid organ transplant, uncontrolled HIV with CD4 \<200, or chronic systemic steroids \>10 mg prednisone-equivalent/day).
* Uncontrolled diabetes (most recent HbA1c \>10% if available within 3 months).
* Active systemic infection or sepsis at time of surgery.
* Inability to complete postoperative follow-up through second-stage closure (e.g., plans to relocate).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07316192
Study Brief:
Protocol Section:
NCT07316192