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:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-26 @ 10:34 AM
NCT ID:
NCT02409628
Eligibility Criteria:
Inclusion Criteria:
* Is the patient at least 18 years of age
* Is the patient male, or is not pregnant or lactating and is using contraception
* Has the patient been diagnosed with a non-melanoma skin cancer (basal cell carcinoma BCC or squamous cell carcinoma SCC) for which the chosen therapeutic option is surgical excision followed by secondary intention healing
* Is the excisional wound greater than 10mm x 10mm in size and less than or equal to 35mm x 35mm after any attempt at primary closure
* Does the patient have limited skin laxity which would make primary closure of the surgical excision difficult
* Is the patient able to understand the aims and objectives of the trial and are they willing to consent
Exclusion Criteria:
* Has the patient been diagnosed with any transmittable viral diseases (HIV, Hepatitis B or C)
* Has the patient been diagnosed with, or is it suspected that they have metastatic disease
* Does the patient have a history of malignant melanoma or any concomitant disease likely to impede wound healing
* Has the patient been diagnosed with pre-existing wound infection
* Is the patient taking any medication known to interfere with skin grafts (i.e. warfarin and other anticoagulants, steroids, NSAIDs and immunosuppressants)
* Has the excised wound been entirely treated by primary closure
* Does the patient have a history of any significant cardiac, pulmonary, renal, hepatic, neurological and/ or immune dysfunction that may affect wound healing
* Does the patient know of any allergy to any of the device materials to be used in the trial
* Does the patient have a known history of poor compliance with medical treatment
* Has the patient participated in this trial previously and healed or been withdrawn
* Is the patient currently participating in any other clinical trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02409628
Study Brief:
Protocol Section:
NCT02409628