DermaClose DUKE Fasciotomy and Wound Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Wound of Skin

Intervention / Treatment
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* Device: DermaClose Continuous External Tissue Expander Device
* Device: DermaClose XL Continuous External Tissue Expander Device
* Device: Conventional wound dressings


Participation Criteria
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Eligibility Criteria
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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: On either the upper or lower extremity (including four-compartment leg fasciotomy), in whom DermaClose and/or DermaClose XL is applied during surgery, OR 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Wound on either the upper or lower extremity with DermaClose and/or DermaClose XL<br>Non-fasciotomy | Device: DermaClose Continuous External Tissue Expander Device<br>* Constant tension and self-tensioning device. Supplied sterile and for single use only.<br>Device: DermaClose XL Continuous External Tissue Expander Device<br>* 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<br>|
| Wound undergoing fasciotomy with DermaClose and/or DermaClose XL<br> | Device: DermaClose Continuous External Tissue Expander Device<br>* Constant tension and self-tensioning device. Supplied sterile and for single use only.<br>Device: DermaClose XL Continuous External Tissue Expander Device<br>* 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<br>|
| Wound undergoing fasciotomy with conventional wound dressings<br> | Device: Conventional wound dressings<br>* Wet-to-dry, gauze, and negative pressure wound therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of investigator-confirmed wound size reduction or assistance with closure of acute full thickness wounds | Wounds may result from four-compartment leg fasciotomies. | Up to 14 Days (or longer if deemed necessary by surgeon) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean percentage of wound size reduction | Calculated at time of device removal. | 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. | 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). | Up to 60 Days | 
| Proportion of wounds requiring subsequent surgical procedure(s) for wound closure | Includes participants with conventional closure modality or skin graft | Up to 60 Days | 
| Number of days until hospital discharge | Median time (min, max) in days will be calculated. | Up tp 60 Days |