DermaClose DUKE Fasciotomy and Wound Study

Terminated

• Conditions: Wound of Skin
• Interventions: Device: Conventional wound dressings; Device: DermaClose Continuous External Tissue Expander Device; Device: DermaClose XL Continuous External Tissue Expander Device

• Registration Number: NCT05330767
• Lead Sponsor: Baxter Healthcare Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-08
• Study First Submitted QC: 2022-04-08
• Study First Posted: 2022-04-15
• Study Start: 2022-08-22
• Primary Completion: 2023-11-13
• Study Completion: 2023-11-13
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-19
• Last Update Posted: 2025-03-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Wound undergoing fasciotomy with DermaClose and/or DermaClose XL	DermaClose XL Continuous External Tissue Expander Device	-
Wound undergoing fasciotomy with conventional wound dressings	Conventional wound dressings	-
Wound undergoing fasciotomy with DermaClose and/or DermaClose XL	DermaClose Continuous External Tissue Expander Device	-
Wound on either the upper or lower extremity with DermaClose and/or DermaClose XL	DermaClose Continuous External Tissue Expander Device	Non-fasciotomy
Wound on either the upper or lower extremity with DermaClose and/or DermaClose XL	DermaClose XL Continuous External Tissue Expander Device	Non-fasciotomy

Primary Outcome Measures

Name	Time	Method
Proportion of investigator-confirmed wound size reduction or assistance with closure of acute full thickness wounds	Up to 14 Days (or longer if deemed necessary by surgeon)	Wounds may result from four-compartment leg fasciotomies.

Secondary Outcome Measures

Name	Time	Method
Proportion of wounds treated with subsequent reconstruction with a skin graft after fasciotomy	Up to 60 Days	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).
Median number of days until wound closure	Up to 14 Days (or longer if deemed necessary by surgeon)	Defined as the ability to complete surgical closure.
Number of days until hospital discharge	Up tp 60 Days	Median time (min, max) in days will be calculated.
Mean percentage of wound size reduction	Up to 14 Days (or longer if deemed necessary by surgeon)	Calculated at time of device removal.
Proportion of wounds requiring subsequent surgical procedure(s) for wound closure	Up to 60 Days	Includes participants with conventional closure modality or skin graft

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States