Back to resultsMEDIHONEY® Gel Versus Collagenase for Wound Debridement
Primary Purpose
Ulcer, Wounds
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Leptospermum Honey (Medihoney)
Collagenase
Sponsored by
About this trial
This is an interventional treatment trial for Ulcer focused on measuring Debridement, collagenase, leptospermum honey
Eligibility Criteria
Inclusion Criteria:
- A signed and dated informed consent has been obtained from the subject.
- Subject is able and willing to comply with study procedures.
- Subject is able to comply with weekly visits.
- Subject is 18 years of age or older.
- There is presence of at least 50% or greater necrotic tissue (including slough and eschar) in the wound bed and a total wound surface area of > 1cm2 to < 64cm2.
- Subject will not have currently used parenteral or oral antibiotics except for UTI.
- Diabetic subjects: HbA1c < 12.0 % within 90 days preceding enrollment.
- Pre-albumin greater than 16 mg/dl within 90 days preceding enrollment.
- Subject with a pressure ulcer must be currently receiving adequate pressure redistribution to the affected area via group 2 or 3 specialty bed, a static wheel chair cushion while patient is out of bed.
- Subject with diabetic plantar surface ulcer will use an offloading boot if ambulatory.
- Subject with a venous ulcer must be currently receiving and using compression therapy that can be managed daily.
- Subject and caregiver are trainable and able to perform dressing changes.
- Subject has no allergies to collagenase or honey.
- Subject has no allergies to semi-occlusive or absorptive secondary dressing.
- If subject has multiple wounds only the wound that fits the inclusion criteria will be selected. If more than one wound meets criteria then the largest wound will be selected.
Exclusion Criteria:
- Steroid use >5mg daily.
- Subject is unable to cooperate with offloading and/or compression recommendations.
- ABI = or >0.8 if the wound is located on a lower extremity.
- Wound has the presence of callus requiring sharp or surgical debridement within 3 days prior to randomization and/or needs debridement using any method other than the study agent throughout study treatment.
- Subject has medical instability as deemed by the investigator.
- Subject is pregnant.
- Subject has participated in another clinical trial or wound dressing evaluation in the 30 days prior to enrollment.
Sites / Locations
- Innovative Healing Systems
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Collagenase
Active leptospermum honey
Arm Description
This is an enzymatic debridement agent to remove non-viable tissue from wounds to be applied daily
This is an active medicinal grade honey used to promote autolytic debridement and applied daily
Outcomes
Primary Outcome Measures
Necrotic tissue reduction
Necrotic tissue percent reduction in the wound at the end of 14 days
Secondary Outcome Measures
Percent wound reduction
Percent wound reduction from randomization at weeks 1, 3 and 4.
Full Information
NCT ID
NCT02482948
First Posted
June 12, 2015
Last Updated
November 30, 2017
Sponsor
Integra LifeSciences Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02482948
Brief Title
MEDIHONEY® Gel Versus Collagenase for Wound Debridement
Official Title
"Prospective, Randomized, Multi-Center, Efficacy Non-inferiority Study of MEDIHONEY® Gel Versus Collagenase for Wound Debridement"
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
Poor enrollment.
Study Start Date
June 2015 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Integra LifeSciences Corporation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare how well two products, Active Leptospermum Honey (ALH) (MEDIHONEY® Gel) and Collagenase (Santyl®), in removing the nonviable (non living) tissue.
Detailed Description
BACKGROUND
An important aspect of wound bed preparation for healing or grafting is the recognition that wounds often have underlying pathogenic abnormalities that cause necrotic tissue to accumulate. Therefore, in order to facilitate wound progression, repeated removal of necrotic tissue may be necessary as long as the wound is chronic. Debridement is defined as the removal of nonviable material, foreign bodies, and poorly healing tissue from a wound. Although surgeons recognize the importance of debridement, few data have been generated in randomized trials to support its use. Traditionally, debridement has been undertaken as a single therapeutic step within defined time frames. The most direct form of debridement is surgical excision. Although this may be applicable for acute wounds, it is unlikely to remove the necrotic burden that may continually accumulate in a chronic wound. Although there are other forms of debridement including enzymatic and biologic; in the case of non-healing wounds, the form of debridement with the most compelling evidence of healing efficacy is autolytic debridement , Therefore, for patients who are poor candidates for surgical debridement or have limited access to a surgeon, autolytic debridement may be considered an effective form of continuous debridement.
2.1 Primary Objective
The primary objective of this study is to evaluate the non-inferiority of MEDIHONEY® Gel (Active Leptospermum Honey-ALH Gel) compared to (Santyl) Collagenase, two FDA cleared/approved treatments, with respect to the percent reduction of necrotic (including slough and eschar) tissue in the wound at the end of 14 days +/- 2 days.
2.2 Secondary Objective
The secondary objective of this study is to compare the two treatment groups with respect to the percent reduction from randomization for necrotic tissue (including slough and eschar) at weeks 1, 3 and 4 +/- 2 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcer, Wounds
Keywords
Debridement, collagenase, leptospermum honey
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Collagenase
Arm Type
Active Comparator
Arm Description
This is an enzymatic debridement agent to remove non-viable tissue from wounds to be applied daily
Arm Title
Active leptospermum honey
Arm Type
Active Comparator
Arm Description
This is an active medicinal grade honey used to promote autolytic debridement and applied daily
Intervention Type
Device
Intervention Name(s)
Active Leptospermum Honey (Medihoney)
Other Intervention Name(s)
Medihoney
Intervention Description
STudy agent to be applied to the wound daily.
Intervention Type
Drug
Intervention Name(s)
Collagenase
Other Intervention Name(s)
Santyl
Intervention Description
Study agent to be applied daily to the wound.
Primary Outcome Measure Information:
Title
Necrotic tissue reduction
Description
Necrotic tissue percent reduction in the wound at the end of 14 days
Time Frame
two weeks
Secondary Outcome Measure Information:
Title
Percent wound reduction
Description
Percent wound reduction from randomization at weeks 1, 3 and 4.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A signed and dated informed consent has been obtained from the subject.
Subject is able and willing to comply with study procedures.
Subject is able to comply with weekly visits.
Subject is 18 years of age or older.
There is presence of at least 50% or greater necrotic tissue (including slough and eschar) in the wound bed and a total wound surface area of > 1cm2 to < 64cm2.
Subject will not have currently used parenteral or oral antibiotics except for UTI.
Diabetic subjects: HbA1c < 12.0 % within 90 days preceding enrollment.
Pre-albumin greater than 16 mg/dl within 90 days preceding enrollment.
Subject with a pressure ulcer must be currently receiving adequate pressure redistribution to the affected area via group 2 or 3 specialty bed, a static wheel chair cushion while patient is out of bed.
Subject with diabetic plantar surface ulcer will use an offloading boot if ambulatory.
Subject with a venous ulcer must be currently receiving and using compression therapy that can be managed daily.
Subject and caregiver are trainable and able to perform dressing changes.
Subject has no allergies to collagenase or honey.
Subject has no allergies to semi-occlusive or absorptive secondary dressing.
If subject has multiple wounds only the wound that fits the inclusion criteria will be selected. If more than one wound meets criteria then the largest wound will be selected.
Exclusion Criteria:
Steroid use >5mg daily.
Subject is unable to cooperate with offloading and/or compression recommendations.
ABI = or >0.8 if the wound is located on a lower extremity.
Wound has the presence of callus requiring sharp or surgical debridement within 3 days prior to randomization and/or needs debridement using any method other than the study agent throughout study treatment.
Subject has medical instability as deemed by the investigator.
Subject is pregnant.
Subject has participated in another clinical trial or wound dressing evaluation in the 30 days prior to enrollment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ravi Patel, MD
Organizational Affiliation
Innovative Healing Systems
Official's Role
Principal Investigator
Facility Information:
Facility Name
Innovative Healing Systems
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
12. IPD Sharing Statement
Learn more about this trial
MEDIHONEY® Gel Versus Collagenase for Wound Debridement
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