DermaClose DUKE Fasciotomy and Wound Study

NCT ID: NCT05330767

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 7 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-22
• Study Completion Date: 2023-11-13

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Non-fasciotomy

DermaClose Continuous External Tissue Expander Device

Intervention Type: DEVICE

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

DermaClose XL Continuous External Tissue Expander Device

Intervention Type: 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

DermaClose Continuous External Tissue Expander Device

Intervention Type: DEVICE

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

DermaClose XL Continuous External Tissue Expander Device

Intervention Type: 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

Conventional wound dressings

Intervention Type: DEVICE

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

Interventions

DermaClose Continuous External Tissue Expander Device

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

Intervention Type: 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

Intervention Type: DEVICE

Conventional wound dressings

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

BXU568622

Identifier Type: -

Identifier Source: org_study_id