DermaClose DUKE Fasciotomy and Wound Study

DermaClose Continuous External Tissue Expander for the Management of Four-Compartment Fasciotomy and Full-Thickness Wounds.

To evaluate the clinical performance of DermaClose and DermaClose XL Continuous External Tissue Expander (CETE) devices to reduce wound size and/or assist with closure in acute full thickness wounds of the skin and assess the need for skin grafting for patients undergoing a four-compartment leg fasciotomy.

Inclusion Criteria:

• Patient is at least 18 years of age at the time of consent.

• Patient with a full thickness acute wound(s) of the skin:

  1. On either the upper or lower extremity (including four-compartment leg fasciotomy), in whom DermaClose and/or DermaClose XL is applied during surgery, OR
  2. Undergoing a four-compartment leg fasciotomy requiring conventional wound dressing.

• Patient has signed a written informed consent form (ICF) per 21 Code of Federal Regulations (CFR) Part 50.55(e).

Exclusion Criteria:

• Patient in whom the product was used off-label (except for patients who have the device on for longer than 14 days)

• Patient with wound(s) that exhibit any of the following:

  • Ischemic tissue,
  • Infected tissue,
  • Acute burned tissue,
  • Fragile tissue at the edges of the wound(s).

• Patient, who in surgeon's opinion, does not fit the criteria for this study.