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

NCT03412929 | Terminated Results FDA Device

• 1 other identifier: R16-017
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Necrotic Tissue

  The percent change in necrotic tissue will serve as the primary endpoint.

  From initial date of application to weekly visits assessed up to 4 weeks.

Secondary Outcomes (5)

• Wound Closure

  From initial date of application to weekly visits assessed up to 4 weeks.

• Infections

  From initial date of application to weekly visits assessed up to 4 weeks.

• Odor

  The odor score will be recorded at weekly visits over four weeks for each subject.

• Pain Score

  The pain score will be recorded at weekly visits over four weeks for each subject.

• Bates-Jensen Wound Assessment Tool Score

  The BWAT score will be recorded at weekly visits over fours weeks for each subject.

Study Arms (1)

Honey Impregnated Dressing

EXPERIMENTAL

Honey Impregnated Dressing

Device: Honey Impregnated Dressing

Interventions

Honey Impregnated Dressing 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.

Honey Impregnated Dressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medline Industries: lead

Study Sites (1)

Northern Illinois Foot & Ankle Specialists

Lake in the Hills, Illinois, 60156, United States

Location

Results Point of Contact

• Title: Stephanie Martynenko
• Organization: Medline Industries, Inc

smartynenko@medline.com

2242163822

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 29, 2018
• Study Start: January 10, 2018
• Primary Completion: January 10, 2019
• Study Completion: May 28, 2019
• Last Updated: April 8, 2020
• Results First Posted: March 20, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)