BIAKOS Antimicrobial Wound Cleanser and BIAKOS Antimicrobial Wound Gel: Providing Biofilm Prevention and Treatment Through Continuum of Care
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Microbial Load
研究概览
简要总结
The proposed study will be a prospective trial of management of acute traumatic wounds (less than 24 hours from injury and without previous intervention aside from a dressing for coverage). The study design involves a prospective single arm, 35 subject study that analyzes the effect of the subsequent application of a novel wound cleanser and wound gel on subjects' acute traumatic wounds and the respective microbial loads over a 28 day study duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Ages 18 to 89 years old.
- •Patients receiving care in the ED/trauma bay or admitted to Brooke Army Medical Center (BAMC) from the ED or trauma bay.
- •At least one wound area must measure equal to or greater than 2cm^2 to include partial or full thickness tears.
- •Wound sustained less than 48-hours from time of enrollment.
- •The wound must be untreated/open beyond bedside stabilization such as irrigation and debridement (i.e., no stitches, steristrips, dermabond, OR washouts, etc).
- •Capable of providing informed written consent by self or through Legally Authorized Representative (LAR).
- •Ability to read/speak English (participant and/ or LAR).
排除标准
- •Ages less than 18 or greater than 89 years old.
- •Patients not receiving care in the ED/trauma bay or admitted to BAMC through the ED or trauma bay.
- •Wound area less than 2 cm
- •Wound sustained greater than 48-hours from the time of enrollment.
- •Wounds that have been closed/repaired at the time of screening (i.e. stitches, steristrips, dermabond, washouts in the OR, etc.) or anytime during the study duration.
- •Not capable of providing informed written consent by self or through LAR.
- •Non-English reading and speaking (participant and/or LAR).
- •Have received more than one dose of antibiotics prior to enrollment or during the study duration.
- •Suspected or confirmed signs/symptoms of active wound infection or gangrene.
- •Patients with osteomyelitis.
- •Wounds with exposed tendons, ligaments, or bone.
- •Patients undergoing active renal dialysis.
- •Patients receiving (within 30 days of enrollment) or scheduled to receive a medication or treatment which is known to negatively affect wound healing such as systemic steroids (i.e. continuous prednisone), immunosuppressive therapy, chemotherapy, autoimmune disease therapy, cytostatic therapy, vascular surgery, angioplasty, or thrombolysis.
- •Pregnant, breastfeeding, or women of childbearing potential who do not agree to use an effective form of contraception during their participation in the study.
- •Participation in another investigational device, drug, or biological trial that may interfere with results within 30 days of screening.
- •Anyone deemed by the PI to be unlikely to comply with all study procedures.
研究组 & 干预措施
Treatment
Antimicrobial Skin & Wound Cleanser and Antimicrobial Wound gel will be subsequently administered to the wound during the 28 day study duration.
干预措施: Antimicrobial Wound Gel (AWG) (Device)
Treatment
Antimicrobial Skin & Wound Cleanser and Antimicrobial Wound gel will be subsequently administered to the wound during the 28 day study duration.
干预措施: Antimicrobial Skin & Wound Cleanser (AWC) (Device)
结局指标
主要结局
Microbial Load
时间窗: 28 days
As indicated semi-quantitatively by MicroGenDx/ Research and Testing Labs LLC (RTL) swab collection and qualitatively by visual assessments and MolecuLight i:X images.
次要结局
- Wound Healing Rates(28 days)