DermaClose DUKE Fasciotomy and Wound Study

NCT05330767 | Terminated FDA Device

• 1 other identifier: BXU568622
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Wound of Skin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Mean percentage of wound size reduction

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

• Median number of days until wound 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

  Up to 60 Days

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

  Up to 60 Days

• Number of days until hospital discharge

  Up tp 60 Days

Study Arms (3)

Wound on either the upper or lower extremity with DermaClose and/or DermaClose XL

Non-fasciotomy

Device: DermaClose Continuous External Tissue Expander Device; Device: DermaClose XL Continuous External Tissue Expander Device

Wound undergoing fasciotomy with DermaClose and/or DermaClose XL

Device: DermaClose Continuous External Tissue Expander Device; Device: DermaClose XL Continuous External Tissue Expander Device

Wound undergoing fasciotomy with conventional wound dressings

Device: Conventional wound dressings

Interventions

DermaClose Continuous External Tissue Expander Device DEVICE

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

Wound on either the upper or lower extremity with DermaClose and/or DermaClose XL; Wound undergoing fasciotomy with DermaClose and/or DermaClose XL

DermaClose XL Continuous External Tissue Expander Device 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 on either the upper or lower extremity with DermaClose and/or DermaClose XL; Wound undergoing fasciotomy with DermaClose and/or DermaClose XL

Conventional wound dressings DEVICE

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

Wound undergoing fasciotomy with conventional wound dressings

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead
• Duke University: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2022
• First Posted: April 15, 2022
• Study Start: August 22, 2022
• Primary Completion: November 13, 2023
• Study Completion: November 13, 2023
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Upon approval of a legitimate research request.
• 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.

Locations

US (1)