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.

Study Overview

• Status: Terminated
• Conditions: Wound of Skin
• Intervention / Treatment: Device: DermaClose Continuous External Tissue Expander Device; Device: DermaClose XL Continuous External Tissue Expander Device; Device: Conventional wound dressings

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation
• Collaborators: Duke University

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2022
• Primary Completion (Actual): November 13, 2023
• Study Completion (Actual): November 13, 2023

Study Registration Dates

• First Submitted: April 8, 2022
• First Submitted That Met QC Criteria: April 8, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: BXU568622

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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)
• IPD Sharing Time Frame: Upon approval of a legitimate research request.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes