Clinical Study to Compare 3 Multi-Layered Foam Dressings for the Management of Chronic Wounds

NCT03662997 | Completed Results FDA Device

• 1 other identifier: MxBFlex02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 5

Brief Summary

A prospective, randomized, controlled clinical trial (RCT) using a cross-over (repeated measures) design to evaluate safety and efficacy of three foam wound dressings in the local management of chronic wounds.

Conditions

Chronic Wound; Venous Leg Ulcer; Diabetic Foot Ulcer

Keywords

Chronic wound; Venous Leg Ulcer; Diabetic Foot Ulcer; Wound dressing

Outcome Measures

Primary Outcomes (2)

• % of Participants With Equal or Better Rate of Dressing Durability

  Dressing strike-through determined @ Wk1 Day 3\&7, and Wk3 Day 17\&21. Dressing strike-through that occurred Day 3 and/or 7, Day 17 and/or 21 were included in final dataset. Contributing factors to strike-through: Saturation of dressing pad: * Inappropriate dressing type * Inappropriate dressing change freq. (i.e. more frequent changes required) * Change in wound condition (e.g. increase in exudate amt) Dislodgement of dressing: * Suboptimal dressing application (e.g. selection of inappropriate dressing size, failure to clean periwound skin before applying dressing, insufficient fixation) * Exposure of dressing to mechanical forces (e.g. off-loading devices, patient mobility) * Patient interference w/ dressing Dressing design deficiency: * Insufficient fluid handling capacity (absorption, retention and/or moisture vapor transmission) * Insufficient adhesion * Insufficient conformability (i.e. ability to conform to body contours \& challenging anatomical wound locations)

  4 weeks

• % of Participants With No Strike-through After 7 Days Wear Time at Day 7 and 21

  Intact dressing after 7 days wear time, assessed @ Wk1 Day7 \& Wk3 Day21 only. 1st week of dressing wear (Wks 1 \& 3) is critical for start of wound healing. Contributing factors to strike-through: Saturation of dressing pad: * Inappropriate dressing type * Inappropriate dressing change freq. (i.e. more frequent changes required) * Change in wound condition (e.g. increase in exudate amt) Dislodgement of dressing: * Suboptimal dressing application (e.g. selection of inappropriate dressing size, failure to clean periwound skin before applying dressing, insufficient fixation) * Exposure of dressing to mechanical forces (e.g. off-loading devices, patient mobility) * Patient interference w/ dressing Dressing design deficiency: * Insufficient fluid handling capacity (absorption, retention and/or moisture vapor transmission) * Insufficient adhesion * Insufficient conformability (i.e. ability to conform to body contours \& challenging anatomical wound locations)

  Weeks 1 and 3

Secondary Outcomes (7)

• % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Before Dressing Removal With Five-layer

  4 weeks

• % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain at Removal With Five-layer

  4 weeks

• % of Participants With Equal or Better Outcomes on Local Wound and Skin Pain Immediately After Dressing Removal With Five-layer

  4 weeks

• % of Participants With Equal or Better Outcomes With Five-layer in Evaluation of the Dressings

  4 weeks

• % of Participants With Equal or Better Outcomes With Five-Layer When Assessing Wound Granulation

  4 weeks

Study Arms (4)

Five-layer vs Hydropolymer

ACTIVE COMPARATOR

Bordered Five-layer Foam Dressing for 2 weeks, followed by Hydropolymer Foam Dressing for 2 weeks.

Device: Bordered Five-Layer Foam Dressing; Device: Hydropolymer Foam Dressing

Hydropolymer vs Five-layer

ACTIVE COMPARATOR

Hydropolymer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks

Device: Bordered Five-Layer Foam Dressing; Device: Hydropolymer Foam Dressing

Five-layer vs Hydrocellular

ACTIVE COMPARATOR

Bordered Five-layer Foam Dressing for 2 weeks, followed by Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks.

Device: Bordered Five-Layer Foam Dressing; Device: Hydrocellular Multi-Layer Foam Dressing

Hydrocellular vs Five-layer

ACTIVE COMPARATOR

Foam Hydrocellular Multi-layer Foam Dressing for 2 weeks, followed by Bordered Five-layer Foam Dressing for 2 weeks

Device: Bordered Five-Layer Foam Dressing; Device: Hydrocellular Multi-Layer Foam Dressing

Interventions

Bordered Five-Layer Foam Dressing DEVICE

Bordered, five-layer, flexible foam dressing with soft silicone adhesive technology

Also known as: Five-layer

Five-layer vs Hydrocellular; Five-layer vs Hydropolymer; Hydrocellular vs Five-layer; Hydropolymer vs Five-layer

Hydropolymer Foam Dressing DEVICE

Hydropolymer, adhesive foam island dressing

Also known as: Hydropolymer

Five-layer vs Hydropolymer; Hydropolymer vs Five-layer

Hydrocellular Multi-Layer Foam Dressing DEVICE

Multi-layered, hydrocellular foam dressing with silicone adhesive

Also known as: Hydrocellular

Five-layer vs Hydrocellular; Hydrocellular vs Five-layer

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects 18-85 years of age with leg and foot ulcers (i.e. VLU, DFU).
• Signed informed consent.
• Subject and/or caregiver must be willing and able to tolerate multi-layered compression bandages when applicable and offloading footwear.
• Study subject must be available and able to visit the clinic weekly for the full 4-week period.

You may not qualify if:

• Pressure ulcers should not be included. Pressure injury as defined by the National Pressure Ulcer Advisory Panel (NPUAP).
• Presence of local wound infection as determined by study doctor based on clinical signs and symptoms.
• Subject has any evidence of peripheral arterial disease (PAD).
• Subject diagnosed with malignancy other than cutaneous basal cell carcinoma.
• Subject has received growth factor therapy (e.g. autologous platelet-rich plasma gel, becaplermin, bilayered cell therapy, dermal substitute, extracellular matrix e.g. amnion, amniotic tissue) within 2 weeks of screening date.
• Pregnancy or lactation at time of study participation.
• Subject is currently receiving or has received radiation or chemotherapy within 3 months of randomization.
• Subject is currently enrolled or participated in another investigational device, drug or biological trial within 30 days of baseline of this study.
• Present history of alcohol or drug abuse.
• Known allergy/hypersensitivity to any of the components of the dressing.
• Subject not suitable for the investigation according to the investigator's judgment.

Sponsors & Collaborators

• Molnlycke Health Care AB: lead

Study Sites (5)

Center for Clinical Research, Inc.

Castro Valley, California, 94546, United States

Location

Center for Clinical Trials, Inc.

San Francisco, California, 94115, United States

Location

Vascular and Wound Care Center

Newark, New Jersey, 07101, United States

Location

SerenaGroup Research Foundation

Pittsburgh, Pennsylvania, 15222, United States

Location

SerenaGroup

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Conditions

Varicose Ulcer; Diabetic Foot

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Foot Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Results Point of Contact

• Title: David Pham
• Organization: Molnlycke Health Care

david.pham@molnlycke.com

678-231-9655

Study Officials

• Oscar Alvarez

  Vascular and Wound Care Center, University Hospital, Newark, NJ, USA

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

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

Model Details: This is a prospective RCT using a crossover design to evaluate safety and efficacy. The study will be conducted in an outpatient setting of an academic clinical center. There will be two participant groups: those with VLU and those with DFU. Approximately 50% of the participants will be in the VLU group and 50% of the participants in the DFU group. Treatment sequence will be randomized so that a fair distribution is achieved. Each participant will receive a 2-week treatment with one of the three dressings followed by a 2-week treatment period with a second dressing (i.e. each participant will receive treatment with two different dressings, either the Bordered Five-Layer Foam Dressing and the Hydropolymer Foam Dressing, or the Bordered Five-Layer Foam Dressing and the Hydrocellular Multi-Layer Foam Dressing) using a cross-over (repeated measures) design, with a total of four study arms.

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: September 10, 2018
• Study Start: March 19, 2019
• Primary Completion: October 1, 2019
• Study Completion: November 15, 2019
• Last Updated: April 1, 2021
• Results First Posted: April 1, 2021

Record last verified: 2020-01

Locations

US (5)