Prospective, Unblinded, Randomized, Controlled Investigation to Evaluate the Clinical Efficacy of PowerHeal™ Bioelectric Bandage in Managing Infected Traumatic Wounds
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Chandan Sen
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- change in wound area
研究概览
简要总结
The goal of this clinical trial is to determine whether the wireless electroceutical dressing (WED) called PowerHeal™ Bioelectric Bandage, improves care of infected wounds by clearing the infection and helping the wound heal better.
The main hypotheses it aims to answer are:
- WED promotes wound closure, as determined by wound area measurement
- WED manages wound infection in civilian and military wounds in Ukraine, as determined by clinical assessment of wound infection by measuring the numbers and types of relevant microbes.
Researchers will compare to see if PowerHeal™ Bioelectric Bandage the dressing used in the SOC group
Participants will get their dressings changed per the protocol, wound image and swab will be taken.
详细描述
Managing bacterial burden is necessary for effective wound healing. Military wounds are severely complex due to rise in multidrug resistant bacterial infections. A FDA cleared commercially available disposable, wireless electroceutical dressing fabric is able to generate a low electric field in presence of exudate in the wound environment. The electric field, along with the micro-molar amounts of superoxide anion radicals that is generated in the wound microenvironment, initiate a bactericidal and a pro-healing signaling cascade resulting in improved wound healing without the encumbrance of a bulky dressing.
There will be five visits over the course of 28 ± 2 days. Participants will be randomized and divided into two groups: one group will receive the standard of care (SOC) dressing and the other will receive the bioelectric bandage. Dressing change intervals will depend on the group the participant randomized to and how exudating the wound is.
The investigation doctor will collect demographic data - such as, age, sex, race; general medical history, and targeted wound data -such as cause, size, location, duration and total number of traumatic wounds. Standard of care clinical lab results (complete blood count, liver and kidney functions, presence and level of inflammation) will also be collected to evaluate body functions and health status . No blood will be collected for this study.
Vital signs (body temperature, respiratory rate, heart rate, blood pressure, level of oxygen in blood) will be measured. The doctor will also look for signs of wound infection (of the investigation wound) including, redness, warmth, swelling, drainage, discoloration, friable granulation, foul odor, necrosis, and pustule/vesicles/boils. Participants will be asked about their pain experience compared to the moment of the injury.
A swab of the investigation wound will be collected per standard study guidelines at each investigation timepoint (unless the wound heals). A member of the study team will clean the wound using sterile sodium chloride solution, then gently rotate a sterile swab over a small area of the wound to collect a sample. All collected wound swabs will be sent to and processed in a central lab within Ukraine to check the infection status of the wound. Microbes detected in the wound will then be further analyzed in a separate central laboratory in the US to look at important factors such as antibiotic resistance. The results of the research wound swabs and analysis data will not be shared with the participant, or their medical care provider.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male participants 18-105 years of age
- •Hospital admission (or boarding in an emergency department or other area awaiting hospital admission) at participating clinical sites in Ukraine
- •At least one infected traumatic wound(s) between 20-40 cm2 in size. Probable or confirmed wound infection(s) will be determined by on-site physicians' clinical judgment and the presence of two or more of the following clinical indicators of wound infection:
- •Presence of worsening pain (from the moment of injury)
- •Erythema (redness)
- •Warmth (heat)
- •Edema (swelling)
- •Purulent exudate (drainage)
- •Delayed healing
- •Discoloration
- •Friable granulation
- •Wound margin breakdown or necrosis with or without fever
- •Pustules, vesicles, boils
- •Participant or legal representative provides written informed consent prior to investigation procedures
- •Participant understands and agrees to adhere to planned investigation procedures
排除标准
- •Allergy to silver or zinc
- •Women who are pregnant or nursing
- •Women of childbearing potential without a documented negative pregnancy test during the current hospitalization or women of childbearing potential who refused pregnancy testing during screening
- •Sponsor or contract research organization (CRO) staff directly involved in the conduct of the investigation, and site staff supervised by the investigator, and their respective family members
- •> 60 days from the initial traumatic injury
- •Known prisoner
- •The patient is expected to be discharged from the hospital within the next 24 hours
- •Medical condition other than the acute traumatic wound (and its manifestations) that is likely to result in death within 14 days of randomization
- •Moribund condition, defined as life expectancy less than 48 hours from randomization
- •Patients undergoing comfort care measures only such that treatment focuses on end-of-life symptom management over prolongation of life
- •Expected inability or unwillingness to participate in study procedures
- •In the opinion of the investigator, participation in the investigation is not in the best interest of the patient
- •Note: Allergies to parabens and acrylates will also be considered. While they are not direct exclusions, participants with these allergies should avoid being enrolled.
研究组 & 干预措施
Standard of Care (SOC) Group
The choice of wound dressing and timing of dressing changes will be determined by the investigation doctor until the participant's wound heals, or until the participant is discharged.
干预措施: Standard of care dressing (Device)
SOC + PowerHeal™ Bioelectric Bandage Group
- The first SOC + PowerHeal™ Bioelectric Bandage will be applied within 24 hours of randomization.
- Each participant is expected to need at least 15 PowerHeal™ Bioelectric Bandages throughout the study.
PowerHeal™ Bandage Change Schedule
Dressing change frequency depends on how much fluid (exudate) the wound produces.
- Day 0-7 and Day 7-14: Minimum of 2 times per week, up to every other day.
- Day 14-28: Minimum of once per week, more as needed dependent on wound exudate.
干预措施: PowerHeal™ Bioelectric Bandage (Device)
SOC + PowerHeal™ Bioelectric Bandage Group
- The first SOC + PowerHeal™ Bioelectric Bandage will be applied within 24 hours of randomization.
- Each participant is expected to need at least 15 PowerHeal™ Bioelectric Bandages throughout the study.
PowerHeal™ Bandage Change Schedule
Dressing change frequency depends on how much fluid (exudate) the wound produces.
- Day 0-7 and Day 7-14: Minimum of 2 times per week, up to every other day.
- Day 14-28: Minimum of once per week, more as needed dependent on wound exudate.
干预措施: Standard of care dressing (Device)
结局指标
主要结局
change in wound area
时间窗: 28 days (± 2 days)
Assess the efficacy of WED in promoting wound closure. The digital photos taken at all visits will be quantitatively evaluated using ImageJ software that can measure the wound area. These measurements will be used for detailed analysis of wound closure over the period of study. Percentage decrease in wound area compared to SOC - from baseline (day 0) to final visit (day 28,± 2 days) will be calculated and analyzed, thus comparing range and rate of change between the two groups SOC and SOC + PowerHeal™ Bioelectric Bandage in aggregate. Adjustment for the correlated variance due to repeated measures will be made throughout the analysis. All analysis will be conducted at 0.05 level of significance.
次要结局
- Change in microbial population - types of strains and numbers of colonies(28 days (± 2 days))