A Case Series Evaluating a Collagen Wound Dressing to Treat Wounds

Medline Industries

Status: Withdrawn

Conditions: Wound

Treatments: Device: Porcine-derived collagen wound dressing

Study type: Interventional

Funder types: Industry

Identifiers

NCT03909503

MED-2018-DIV71-029

Details and patient eligibility

About

Chronic wounds are a source of significant morbidity and escalated healthcare costs. The wound care professional has a myriad of modern wound dressings to choose from, each of which has benefits and drawbacks. An understanding of how a given dressing performs in healing a particular wound is crucial in order to determine a clinical mapping of wound dressings to wound types; such a categorization would lead to more efficient clinical decision making and better patient outcomes. This case series will evaluate the ability of a porcine-derived collagen dressing to improve healing of chronic lower-extremity wounds.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Has at least one of the following types of wounds below the knee: diabetic ulcer, pressure ulcer, venous ulcer, ulcer of mixed-vascular origin, traumatic wound, post-surgical wound
• Wound has been present for at least four weeks
• Wound is free of necrotic tissue or it is possible for necrotic tissue to be removed by typical debridement practices prior to or during treatment phase
• Wound has not healed after using at least one other type of advanced wound care treatment
• Wound size is between 1 and 100 cm2
• Patient has adequate circulation, as demonstrated by biphasic or triphasic Doppler waveform, measured within three months prior to study enrollment. If monophasic on exam, then non-invasive tests must display Ankle Brachial Index greater than 0.8 and no worse than mild disease on segmental pressures.
• Wound is free of infection and absence of osteomyelitis.

Exclusion criteria

• Pregnant, planning to become pregnant during the study timeframe, or breast feeding
• Has a known allergy to porcine products
• Has an allergy or sensitivity to any type of collagen
• Unable or unwilling to receive porcine collagen
• Wound is infected or there is presence of osteomyelitis
• Inability, in the opinion of the Investigator to follow protocol requirements, attend follow up visits in a timely manner, or otherwise comply with the requirements of the protocol

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Porcine-derived collagen wound dressing

Experimental group

Description:

The dressing is a sheet of collagen composed of type I collagen derived from porcine peritoneal membrane. The dressing also contains additional components from the procine extracellular matrix. The dressing is a currently marketed, cleared device in the United States indicated for the management of full- and partial-thickness wounds, including: pressure ulcers, diabetic ulcers, venous ulcers, and several other wound types.

Treatment:

Device: Porcine-derived collagen wound dressing