A Multi-Center, Prospective, Randomized, Blinded Assessor, Trial Comparing the Safety and Efficacy of the RedDress Wound Care System (RD1) to a Silver-impregnated Hydrofiber Dressing (Aquacel AG®) in Patients With Stage III Pressure Ulcers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by RedDress Ltd..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
RedDress Ltd.
ClinicalTrials.gov Identifier:
NCT01396837
First received: July 5, 2011
Last updated: October 6, 2011
Last verified: October 2011
  Purpose

The purpose of this study is to Compare the Safety and Efficacy of the RedDress Wound Care System (RD1) to a silver-impregnated hydrofiber dressing (Aquacel AG®) in patients with stage III pressure ulcers.


Condition Intervention Phase
Pressure Ulcers Stage III
Device: RedDress Wound Care System (RD1)
Device: Aquacel AG®
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center, Prospective, Randomized, Controlled, Blinded Assessor, Trial Comparing the Safety and Efficacy of the RedDress Wound Care System (RD1) to a Silver-impregnated Hydrofiber Dressing (Aquacel AG®) in Patients With Stage III Pressure Ulcers

Resource links provided by NLM:


Further study details as provided by RedDress Ltd.:

Primary Outcome Measures:
  • Complete wound closure at 18 weeks [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    The number incidence of complete wound closure at 18 weeks (defined as skin re-epithelialization without drainage or dressing requirements confirmed at 2 consecutive study visits 2 weeks apart) for pressure ulcers treated with RD1 versus Oasis® wound matrix.


Secondary Outcome Measures:
  • The incidence of adverse events [ Time Frame: An average of 1.5 years ] [ Designated as safety issue: Yes ]
    To compare the 2 treatment arms in regards to the number of incidence of adverse events

  • The incidence of complete closure at 12 and 18 weeks [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
    To compare the 2 treatment arms in the number of incidence of complete closure at 12 and 18 weeks

  • The incidence of device related adverse events [ Time Frame: An average of 1.5 years ] [ Designated as safety issue: Yes ]
    To Assess the safety of RD1 in the treatment of pressure ulcers by the number of incidence of device related adverse events (DRAE)

  • Incidence of infection [ Time Frame: An average of 1.5 years ] [ Designated as safety issue: Yes ]
    To compare the incidence of infection in both study arms

  • Assessment of pain [ Time Frame: An average of 1.5 years ] [ Designated as safety issue: No ]
    To compare the ulcer pain in both study arms

  • The time to complete wound closure using Cox regression [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
    To compare the time to complete wound closure using Cox regression using the stratified variables and significant baseline wound/patient characteristics, such as diabetes, between the 2 arms.


Estimated Enrollment: 140
Study Start Date: December 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RD1
RedDress Wound Care System
Device: RedDress Wound Care System (RD1)
Weekly application. A blood based wound care treatment
Other Name: RedDress Wound Care System
Active Comparator: Aquacel AG®
Aquacel AG®
Device: Aquacel AG®
Application every other day.
Other Name: Aquacel AG

Detailed Description:

Currently, the standard of care for a ≥ stage II pressure ulcer in addition to offloading is to provide a moist wound healing environment and a means to control exudate. Several dressings are currently used in this regard, including hydrogel-, hydrocolloid-, and alginate-based dressings, with or without silver ions impregnated into the dressing, and several hydrogel- or alginate-based dressings have been tested in randomized controlled trials for efficacy , such as Aquacel AG®. While RD1 functions providing a functional extracellular matrix which protects the wound and assists in the healing process by recreating a "healing environment," we propose to use a hydrofiber-based dressing with impregnated silver ions (Aquacel AG®) to determine if RD1 will provide an efficacy advantage. This trial is designed to test the null hypothesis that the two products are substantially equivalent in management of Stage III pressure ulcers. Rejection of the null hypothesis because healing rates are faster with RD1 compared to Aquacel AG® would confirm that RD1 is superior in efficacy to Aquacel AG®. Pressure ulcers have been chosen due to the large unmet need for products to treat this wound type.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥18 years of age.
  • Full-thickness wound (Stage III, NPUAP 1989).
  • Prior to inclusion of an ulcer in the study, each wound will be reviewed for eligibility by an independent assessor using a central online review process that includes images of the ulcer.
  • For patients with potentially multiple eligible pressure ulcers, these ulcers will be numbered 1, 2, 3, etc. based on increasing ulcer size. Pre-prepared randomization tables for 2, 3, 4, and 5 groups will be supplied to centers so that the index ulcer can be chosen at random.
  • Ulcer size between 2 cm2 and 30 cm2 .
  • Ulcer duration of ≥ 30 days. Time 0 for ulcer duration of ≥ 30 days is defined as the first day of screening (i.e., day -14). Subjects will need to meet all inclusion criteria, including lack of ulcer healing until day 0, the day of randomization.
  • Study ulcer separated from other ulcers by at least 4 cm.
  • Ulcer free of clinical signs of infection.
  • Post-debridement, ulcer free of necrotic tissue.
  • HbA1c ≤ 10.0% (diabetic patients) provided the patient will be under the care of a diabetologist/endocrinologist, with the goal of meeting ADA treatment guidelines.
  • No evidence of malnutrition (serum albumin <2.5 g/dL).
  • Demonstrated adequate offloading regimen.
  • Subject must be willing to comply with the protocol including having blood drawn to create the RD1.
  • Female subjects who are capable of conceiving and all males capable of insemination must use an acceptable form of contraception in order to participate in the study (acceptable forms of contraception include condoms for males and contraceptive pills or IUDs for women).

Exclusion Criteria:

  • Ulcer not of pressure pathophysiology (e.g., venous, vasculitic, radiation, rheumatoid, collagen vascular disease, or arterial etiology, or diabetic foot ulcers.). For diabetic subjects, heel pressure ulcers classified as pressure ulcers are not excluded.
  • Ulcer associated with a fistula.
  • Presence of underlying osteomyelitis.
  • Patient with a proven sepsis established by a blood culture in the past 2 weeks, or confirmed active infection likely to interfere with trial, such as urine tract infection.
  • History of alcohol or substance abuse, within the previous year
  • Received systemic corticosteroids or immunosuppressive agents, radiation therapy or chemotherapy, electrostimulation, or growth factors during the 30 days preceding treatment
  • Wound on a patient who has a life expectancy of less than 12 months.
  • Subjects who are cognitively impaired and have a healthcare proxy or those who are cognitively impaired and clearly do not understand the contents of the informed consent form.
  • Cannot withdraw blood in the required amount (30 mL per week) technically.
  • Known coagulation problems, abnormal thrombocytes level or if heparin is given intravenously. Patients who are taking coumadin, aspirin, or Plavix (clopidogrel) will not be excluded.
  • Hemoglobin anemia (< 10 g/dL).
  • If ulcer area decreases by ≥ 30% during the initial 2-week screening and standard of care phase, or if the ulcer area increases ≥ 30%, subject will be excluded.
  • Women who are pregnant or currently breast feeding.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alon Kushnir CEO, RedDress Ltd.
ClinicalTrials.gov Identifier: NCT01396837     History of Changes
Other Study ID Numbers: RD002
Study First Received: July 5, 2011
Last Updated: October 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by RedDress Ltd.:
Pressure Sores
Pressure ulcer

Additional relevant MeSH terms:
Pressure Ulcer
Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes
Carboxymethylcellulose Sodium
Laxatives
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014