A Clinical Evaluation of a Honey Impregnated Dressing at Removing Necrotic Tissue From Chronic Wounds

NCT ID: NCT03412929

Last Updated: 2020-04-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-10
• Study Completion Date: 2019-05-28

Brief Summary

The purpose of this study is to evaluate the effectiveness of a honey-impregnated wound dressing at removing necrotic tissue in subjects with chronic foot or ankle wounds.

Conditions

Wound Heal; Necrotic Tissue Removal

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Honey Impregnated Dressing

Honey Impregnated Dressing

Group Type: EXPERIMENTAL

Honey Impregnated Dressing

Intervention Type: DEVICE

The investigational product being examined contains 100% Manuka honey and is ideal for difficult to dress wounds. The dressing provides a moist wound environment to help promote autolytic debridement. The dressing is ideal for partial or full thickness wounds with moderate-to-heavy drainage.

Interventions

Honey Impregnated Dressing

The investigational product being examined contains 100% Manuka honey and is ideal for difficult to dress wounds. The dressing provides a moist wound environment to help promote autolytic debridement. The dressing is ideal for partial or full thickness wounds with moderate-to-heavy drainage.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Male or female at least 18 years of age
• Subject has a qualified chronic foot or ankle wound, sized 1cm2 to 25 cm2 for ≥ 4 weeks in duration
• Must have necrotic tissue at least 25% of wound area
• The wound type matches one of the indicated wounds listed on the product labeling:
• Leg ulcers
• Pressure ulcers
• Diabetic foot ulcers
• First and second degree burns
• Surgical wounds
• Trauma wounds
• Subject has adequate circulation as demonstrated by biphasic or triphasic Doppler waveform, consistent with adequate blood flow, within 3 months prior to study enrollment. If monophasic on exam, the non-invasive tests must display Ankle Brachial Index over 0.8 and no worse than mild disease on segmental pressures.
• Subject is likely to be compliant with instructions for case, such as following institutional standard of care directions, offloading, and keeping the wound area protected from environmental contaminants
• Type I/II diabetic subjects that meet the following criteria:
• Random blood glucose is less than 450 mg/dL within 30 days of the screening visit

Exclusion Criteria

• Subject has a known sensitivity or allergy to honey based products, bee venom, or other ingredients in product
• The subject is breastfeeding, pregnant, or has intentions of becoming pregnant during the course of their study participation
• Wound duration ≥ 52 weeks
• The subject has a prognosis that indicated unlikely survival past the study period
• The subject is currently receiving dialysis
• Gangrene is present in the target wound
• Patient's wound is infected
• The subject's diagnosis indicates third degree burns
• The subject has received any treatment prior to study enrollment that may, in the opinion of an Investigator, affect the outcome of the study
• In the opinion of an Investigator, the subject is otherwise not suitable for study participation, such as the subject is likely to be non-compliant with study requirements

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medline Industries

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Northern Illinois Foot & Ankle Specialists

Lake in the Hills, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R16-017

Identifier Type: -

Identifier Source: org_study_id