NCT05330767

DermaClose DUKE Fasciotomy and Wound Study

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 7 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-08-22
• Primary completion: 2023-11-13
• Completion: 2023-11-13
• First posted: 2022-04-15
• Last updated: 2025-03-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study