Wound of Skin
Conditions
Brief summary
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.
Interventions
DEVICEDermaClose Continuous External Tissue Expander Device
Constant tension and self-tensioning device. Supplied sterile and for single use only.
DEVICEDermaClose XL Continuous External Tissue Expander Device
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
Wet-to-dry, gauze, and negative pressure wound therapy.
Sponsors
Duke University
Baxter Healthcare Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of investigator-confirmed wound size reduction or assistance with closure of acute full thickness wounds | Up to 14 Days (or longer if deemed necessary by surgeon) | Wounds may result from four-compartment leg fasciotomies. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean percentage of wound size reduction | Up to 14 Days (or longer if deemed necessary by surgeon) | Calculated at time of device removal. |
| Median number of days until wound closure | Up to 14 Days (or longer if deemed necessary by surgeon) | Defined as the ability to complete surgical closure. |
| Proportion of wounds treated with subsequent reconstruction with a skin graft after fasciotomy | Up to 60 Days | 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). |
| Proportion of wounds requiring subsequent surgical procedure(s) for wound closure | Up to 60 Days | Includes participants with conventional closure modality or skin graft |
| Number of days until hospital discharge | Up tp 60 Days | Median time (min, max) in days will be calculated. |
Countries
United States
Outcome results
None listed