MEDIHONEY® Gel Versus Collagenase for Wound Debridement

"Prospective, Randomized, Multi-Center, Efficacy Non-inferiority Study of MEDIHONEY® Gel Versus Collagenase for Wound Debridement"

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.

Study Overview

• Status: Terminated
• Conditions: Ulcer; Wounds
• Intervention / Treatment: Drug: Collagenase; Device: Active Leptospermum Honey (Medihoney)

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33614
      • Innovative Healing Systems

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Collagenase; This is an enzymatic debridement agent to remove non-viable tissue from wounds to be applied daily	Drug: Collagenase; Study agent to be applied daily to the wound.; Other Names: Santyl
Active Comparator: Active leptospermum honey; This is an active medicinal grade honey used to promote autolytic debridement and applied daily	Device: Active Leptospermum Honey (Medihoney); STudy agent to be applied to the wound daily.; Other Names: Medihoney

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Necrotic tissue reduction	Necrotic tissue percent reduction in the wound at the end of 14 days	two weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent wound reduction	Percent wound reduction from randomization at weeks 1, 3 and 4.	4 weeks

Collaborators and Investigators

• Sponsor: Integra LifeSciences Corporation
• Investigators: Principal Investigator: Ravi Patel, MD, Innovative Healing Systems

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: June 12, 2015
• First Submitted That Met QC Criteria: June 25, 2015
• First Posted (Estimate): June 26, 2015

Study Record Updates

• Last Update Posted (Actual): December 2, 2017
• Last Update Submitted That Met QC Criteria: November 30, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Debridement; collagenase; leptospermum honey
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: Derma-MH001