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DermaClose DUKE Fasciotomy and Wound Study

NCT05330767 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 7

Last updated 2025-03-21

No results posted yet for this study

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

Interventions

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

DEVICE

Conventional wound dressings

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

Sponsors & Collaborators

  • Duke University

    collaborator OTHER

  • Baxter Healthcare Corporation

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-22
Primary Completion
2023-11-13
Completion
2023-11-13
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05330767 on ClinicalTrials.gov