MEDIHONEY® Gel Versus Collagenase for Wound Debridement

• Status: Terminated
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Derma Sciences, Inc.; Integra LifeSciences Corporation

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.