A Case Series Evaluating a Collagen Wound Dressing to Treat Wounds

NCT03909503 | Withdrawn FDA Device

• 1 other identifier: MED-2018-DIV71-029
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Wound

Outcome Measures

Primary Outcomes (1)

• Change in wound size over a twelve week period

  Baseline to 84 days

Secondary Outcomes (2)

• Bates-Jensen Wound Assessment Tool score

  Baseline to 84 days

• Change in reported pain level: verbal numeric pain rating scale

  Baseline to 84 days

Study Arms (1)

Porcine-derived collagen wound dressing

EXPERIMENTAL

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.

Device: Porcine-derived collagen wound dressing

Interventions

Porcine-derived collagen wound dressing DEVICE

Patients who meet the inclusion criteria will be treated with porcine-derived collagen dressings. The dressing will be used in accordance with its label. After cleansing the wound, the dressing will be placed on the wound. Appropriate primary and secondary dressings will be placed over the intervention product. Patients will visit the clinic once per week to have their dressings re-applied. Wound evaluations will take place once per week with the intervention lasting up to twelve weeks. Concomitant standard of care such as compression for venous ulcers will be provided according to individual patient needs.

Porcine-derived collagen wound dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medline Industries: lead

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 10, 2019
• Study Start: September 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: February 1, 2022
• Last Updated: October 20, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share