EktoTherix™ Regenerative Tissue Scaffold for Repair of Surgical Excision Wounds

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• •Has the patient participated in this trial previously and healed or been withdrawn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