2-part, Randomized, Double Blind, Prospective, Single Center, Controlled Trial to Investigate an Antimicrobial Skin and Wound Cleanser and an Antimicrobial Barrier Film Dressing on the Rates of Healing for Chronic Wounds
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Complete Closure
研究概览
简要总结
This is a 2-part pilot study to determine the clinical effectiveness of two new antimicrobial products on the complete healing of chronic wounds.
详细描述
Part 1 of this study will involve 5 patients with qualified chronic wounds which will receive active treatment with both the Atteris Antimicrobial Skin and Wound Cleanser (AWC) and the Atteris Antimicrobial Barrier Film Dressing (ABFD) for a 6-week period with a 12 week follow-up in order to optimize the final study application protocols. Part 2 of this study is a randomized, double blind, 2 by 2 factorial, controlled study comparing the AWC and/or the ABFD with 100 research subjects and n=25 subjects per cell. Patients will be randomized to receive either active AWC and active ABFD, or active AWD and placebo ABFD, or placebo AWC and active ABFC, or AWC placebo and ABFD placebo in addition to standard of care (SOC). The active AWC active ABFD versus AWC placebo ABFD placebo statistical contrast will be of most importance and the clinical expectation is wounds treated with the active forms of these products will heal faster than wounds treated with double placebo and this will additionally provide data to power a future definitive study to compare the healing potential of the two therapeutic modalities (AWC, ABFD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Active product containers and placebo product containers will have identical labels. Product numbers to differentiate active versus placebo will be assigned and known only by the statistician.
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between the ages of 18 and 89
- •If IDDM or NIDDM, glycosylated hemoglobin, HgbA1c, ≤10%
- •Presence of chronic Wound of any etiology between 0.5 cm2 and 15 cm2, inclusive, post debridement
- •Wound has been present for at least 4 weeks, but not greater than 52 weeks at time of screening
- •Non-surgical wounds which meet the clinical definition of chronic between 0.5 cm2 and 15 cm2
- •Adequate arterial perfusion of the affected limb, defined as at least one of the following:
- •Ankle-brachial index (ABI) ≥0.7 and ≤1.2
- •Dorsum transcutaneous oxygen test ≥ 30 mm Hg
- •Biphasic or triphasic Doppler waveforms at screening
- •Patient and/or caregiver have the ability and willingness to understand and comply with study procedures and give written, informed consent prior to enrollment in the study or initiation of study procedures.
排除标准
- •Suspected or confirmed signs/symptoms of active wound infection or gangrene
- •Hyperbaric Oxygen Therapy, any duration, within the past 12 months
- •Osteomyelitis
- •Use of oral or IV antibiotic/antimicrobial agents within 2 days (48 hours) of baseline
- •Subjects who have received growth factor therapy (e.g., autologous platelet-rich plasma gel, becaplermin,) within 28 days of screening
- •Subjects who have received dermal substitutes (e.g. Integra, collagen, micronized cadaver skin, bilayered cell therapy, dermal substitute, extracellular matrix etc.) within 28 days of screening.
- •Pyoderma gangrenosum, or Reynaud's disease
- •Wound with necrotic tissue covered with slough or eschar that cannot be debrided
- •Chronic wounds with exposed bone
- •Wounds with fistulas or deep sinus tracks of unknown depth
- •Active Charcot foot on the study limb
- •Receiving hemodialysis or peritoneal dialysis
- •History of malignancy excluding non-melanoma skin cancer
- •Treatment with radiation or chemotherapy within 3 months of screening
- •Known immunosuppression, excluding diabetes mellitus
- •Receiving (within 30 days of enrollment) or scheduled to receive a medication or treatment which is known to affect wound healing, such as systemic steroids (such as daily prednisone), immunosuppressive therapy, radiation or chemotherapy of any kind, autoimmune disease therapy or cytostatic therapy
- •Subjects with known alcohol or substance abuse within 6 months of screening
- •Subjects with known allergy to PHMB, acrylate polymer and silicone
- •Pregnancy or breastfeeding at time of screening
- •Participation in another investigational device, drug, or biological trial that may interfere with results within 6 months of screening
研究组 & 干预措施
Active AWC + Active ABFD
Active Antimicrobial Wound Cleanser + Active Antimicrobial Barrier Film Dressing + SOC
干预措施: Atteris Antimicrobial Skin and Wound Cleanser (Device)
Placebo AWC + Placebo ABFD
Placebo Antimicrobial Wound Cleanser + Placebo Antimicrobial Barrier Film Dressing + SOC
干预措施: Atteris Antimicrobial Skin and Wound Cleanser (Device)
Active AWC + Active ABFD
Active Antimicrobial Wound Cleanser + Active Antimicrobial Barrier Film Dressing + SOC
干预措施: Atteris Antimicrobial Barrier Film Dressing (Device)
Active AWC + Placebo ABFD
Active Antimicrobial Wound Cleanser + Placebo Antimicrobial Barrier Film Dressing + SOC
干预措施: Atteris Antimicrobial Skin and Wound Cleanser (Device)
Active AWC + Placebo ABFD
Active Antimicrobial Wound Cleanser + Placebo Antimicrobial Barrier Film Dressing + SOC
干预措施: Atteris Antimicrobial Barrier Film Dressing (Device)
Placebo AWC + Active ABFD
Placebo Antimicrobial Wound Cleanser + Active Antimicrobial Barrier Film Dressing + SOC
干预措施: Atteris Antimicrobial Skin and Wound Cleanser (Device)
Placebo AWC + Active ABFD
Placebo Antimicrobial Wound Cleanser + Active Antimicrobial Barrier Film Dressing + SOC
干预措施: Atteris Antimicrobial Barrier Film Dressing (Device)
Placebo AWC + Placebo ABFD
Placebo Antimicrobial Wound Cleanser + Placebo Antimicrobial Barrier Film Dressing + SOC
干预措施: Atteris Antimicrobial Barrier Film Dressing (Device)
结局指标
主要结局
Complete Closure
时间窗: 6 weeks of active treatment
Did the chronic wounds achieve complete closure as defined by 100% epithelialization requiring no additional treatment? (YES or NO)
次要结局
- Pain(6 weeks)
- Infective episodes(6 weeks)
- Wound Dimension Decreases(6 and 12 weeks)