DermaClose DUKE Fasciotomy and Wound Study

Baxter Healthcare Corporation7 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Wound of Skin

Interventions

DermaClose Continuous External Tissue Expander DeviceDEVICE

Constant tension and self-tensioning device. Supplied sterile and for single use only.

DermaClose XL Continuous External Tissue Expander DeviceDEVICE

Intended for large wounds that are greater than 8 cm in width. Constant tension and self-tensioning device. Supplied sterile and for single use only

Conventional wound dressingsDEVICE

Wet-to-dry, gauze, and negative pressure wound therapy.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Proportion of investigator-confirmed wound size reduction or assistance with closure of acute full thickness wounds

Wounds may result from four-compartment leg fasciotomies.

Time frame: Up to 14 Days (or longer if deemed necessary by surgeon)

Secondary Outcomes

Mean percentage of wound size reduction

Calculated at time of device removal.

Time frame: Up to 14 Days (or longer if deemed necessary by surgeon)

Median number of days until wound closure

Defined as the ability to complete surgical closure.

Time frame: Up to 14 Days (or longer if deemed necessary by surgeon)

Proportion of wounds treated with subsequent reconstruction with a skin graft after fasciotomy

Plastic surgery may be consulted for reconstruction by the referring surgeon, or the patient may be recommended for study inclusion by the referring surgeon who plans on using conventional dressing to manage the wound(s).

Time frame: Up to 60 Days

Proportion of wounds requiring subsequent surgical procedure(s) for wound closure

Includes participants with conventional closure modality or skin graft

Time frame: Up to 60 Days

Number of days until hospital discharge

Median time (min, max) in days will be calculated.

Time frame: Up tp 60 Days

Data from ClinicalTrials.gov

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