DermaClose DUKE Fasciotomy and Wound Study

Wound of Skin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05330767
• Other study ID #: BXU568622
• Status: Recruiting
• Start date: August 22, 2022
• Est. completion date: October 23, 2023

Study information

• Verified date: February 2023
• Source: Baxter Healthcare Corporation
• Contact: Baxter Clinical Trials Disclosure Call Center
• Phone: (224) 948-7359
• Email: Global_CORP_ClinicalTrialsDisclosure[@]baxter.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: October 23, 2023
• Est. primary completion date: October 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Wound of Skin
• Wounds and Injuries

Intervention

Device:
• DermaClose Continuous External Tissue Expander Device
Constant tension and self-tensioning device. Supplied sterile and for single use only.
• 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
• Conventional wound dressings
Wet-to-dry, gauze, and negative pressure wound therapy.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation	Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean percentage of wound size reduction	Calculated at time of device removal.	Up to 14 Days (or longer if deemed necessary by surgeon)
Secondary	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)
Secondary	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
Secondary	Proportion of wounds requiring subsequent surgical procedure(s) for wound closure	Includes participants with conventional closure modality or skin graft	Up to 60 Days
Secondary	Number of days until hospital discharge	Median time (min, max) in days will be calculated.	Up tp 60 Days