Back to resultsA Case Series Evaluating a Collagen Wound Dressing to Treat Wounds
Primary Purpose
Wound
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Porcine-derived collagen wound dressing
Sponsored by
About this trial
This is an interventional treatment trial for Wound
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Porcine-derived collagen wound dressing
Arm 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.
Outcomes
Primary Outcome Measures
Change in wound size over a twelve week period
Secondary Outcome Measures
Bates-Jensen Wound Assessment Tool score
The Bates-Jensen Wound Assessment tool score will be used to assess the wound's status throughout the study. The wound size score ranges from 0 to 5. The wound depth score ranges from 0 to 5. The wound edge score ranges from 0 to 5. The wound undermining score ranges from 0 to 5. The necrotic tissue type score ranges from 1 to 5. The necrotic tissue amount ranges from 1 to 5. The exudate type score ranges from 1 to 5. The exudate amount score ranges from 1 to 5. The skin color surrounding wound score ranges from 1 to 5. The peripheral tissue edema score ranges from 1 to 5. The peripheral tissue induration score score ranges from 1 to 5. The granulation tissue score ranges from 1 to 5. The epithelialization score ranges from 1 to 5. The total score from these sub-scores added together is used as the total BWAT score. For all sub-score values, a value of 0 or 1 is a better outcome. A score of 1 indicates the healthiest and 5 indicates the unhealthiest attribute for each characteristic.
Change in reported pain level: verbal numeric pain rating scale
The pain will be recorded using a verbal numeric pain rating scale from 0 to 10. A score of 0 indicates no pain and a score of 10 indicates the highest rated pain.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03909503
Brief Title
A Case Series Evaluating a Collagen Wound Dressing to Treat Wounds
Official Title
A Case Series Evaluating a Porcine-derived Collagen Wound Dressing to Treat Chronic Lower Extremity Wounds
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Business decision
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
December 1, 2021 (Anticipated)
Study Completion Date
February 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medline Industries
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Porcine-derived collagen wound dressing
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Porcine-derived collagen wound dressing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in wound size over a twelve week period
Time Frame
Baseline to 84 days
Secondary Outcome Measure Information:
Title
Bates-Jensen Wound Assessment Tool score
Description
The Bates-Jensen Wound Assessment tool score will be used to assess the wound's status throughout the study. The wound size score ranges from 0 to 5. The wound depth score ranges from 0 to 5. The wound edge score ranges from 0 to 5. The wound undermining score ranges from 0 to 5. The necrotic tissue type score ranges from 1 to 5. The necrotic tissue amount ranges from 1 to 5. The exudate type score ranges from 1 to 5. The exudate amount score ranges from 1 to 5. The skin color surrounding wound score ranges from 1 to 5. The peripheral tissue edema score ranges from 1 to 5. The peripheral tissue induration score score ranges from 1 to 5. The granulation tissue score ranges from 1 to 5. The epithelialization score ranges from 1 to 5. The total score from these sub-scores added together is used as the total BWAT score. For all sub-score values, a value of 0 or 1 is a better outcome. A score of 1 indicates the healthiest and 5 indicates the unhealthiest attribute for each characteristic.
Time Frame
Baseline to 84 days
Title
Change in reported pain level: verbal numeric pain rating scale
Description
The pain will be recorded using a verbal numeric pain rating scale from 0 to 10. A score of 0 indicates no pain and a score of 10 indicates the highest rated pain.
Time Frame
Baseline to 84 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Case Series Evaluating a Collagen Wound Dressing to Treat Wounds
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