DermaClose DUKE Fasciotomy and Wound Study

Baxter

Status

Terminated

Conditions

Wound of Skin

Treatments

Device: DermaClose Continuous External Tissue Expander Device

Device: Conventional wound dressings

Device: DermaClose XL Continuous External Tissue Expander Device

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05330767

BXU568622

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.