Slow enrollment

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.

The study population will include patients who have acute full thickness wound(s) of the skin (including four-compartment leg fasciotomy) and in whom DermaClose and/or DermaClose XL, or conventional dressing is used.

Sharing of Clinical Trial Data: Baxter is committed to sharing clinical trial data with external medical experts and scientific researchers in the interest of advancing public health. As such, Baxter will supply anonymized Individual Patient Datasets (IPD) and supporting documents (synopsis of clinical study reports, protocol and SAP's)

Upon approval of a legitimate research request.

Research requests will be reviewed by qualified medical and scientific experts within the company. If Baxter agrees to the release of clinical data for research purposes, the requestor will be required to sign a data sharing agreement (DSA) in order to ensure protection of patient confidentiality and any intellectual property rights of Baxter prior to the release of any data.