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A Case Series Evaluating a Collagen Wound Dressing to Treat Wounds

NCT03909503 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-10-20

No results posted yet for this study

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

Interventions

DEVICE

Porcine-derived collagen wound dressing

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.

Sponsors & Collaborators

  • Medline Industries

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2021-12-01
Completion
2022-02-01
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03909503 on ClinicalTrials.gov