Feasibility Clinical Trial to Assess the Safety and Potential Effectiveness of Microlyte® DualGuard Wound Dressing on Surgically Created Partial-thickness Donor Site Wounds on Patients Requiring Split- Thickness Skin Grafting; the SAGGA Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 53
- 试验地点
- 3
- 主要终点
- Adverse event occurrence, including infection
研究概览
简要总结
The primary purpose of this research is to evaluate the safety and effectiveness of Microlyte® DualGuard wound dressing in the healing of partial thickness donor site wounds, also known as skin graft donor sites. This research will assess wound healing, the occurrence of infection, allergic reaction, pain, and itching while subjects are in the hospital and after discharge. Subjects will complete clinic visits through 12 weeks. This research will also assess the occurrence of donor site wound infection, pain and itching, and scarring at 12 weeks, assessed by subjects using the Patient and Observer Scar Assessment Scale (POSAS).
详细描述
This study is a multi-center randomized, controlled, open-label, split-wound clinical trial to assess the safety and potential effectiveness in wound healing of the Microlyte® DualGuard wound dressing in surgically created partial-thickness donor site wounds (DSW) on patients requiring split-thickness skin grafting.
This clinical trial is designed to demonstrate safety and effectiveness of the Microlyte® DualGuard wound dressing. We note that this clinical trial is designed for the management of surgically created clean acute donor-site wounds. These surgically clean acute wounds have high tendency to heal with the standard of care if supervised diligently, especially under the monitoring of a clinical trial.
Donor site wounds are created regularly in surgical hospitals as a means to utilize split-thickness skin grafts for closure of chronic, traumatic, infectious, oncologic, burn and other wounds. A donor site wound is a reproducible partial thickness wound. At the same time, it is associated with morbidity including pain, long healing times, risk of infection, and long-term cosmetic changes. Thus, it is the ideal model for assessment of safety and effectiveness of topical products engineered for wound healing and infection control. The donor site can easily be divided into two halves that are amenable to randomization using intra-patient controls to maximize the chances of assessing safety and effectiveness.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients where creation of a donor site wound for any indication including chronic wound, burn wound, surgical/traumatic wound, and tumor excision is indicated.
- •Thigh donor site wound (DSW) location.
- •At least 22 years of age.
- •Ability to understand and provide a signed and dated informed consent form.
- •Stated willingness to comply with all study procedures and availability for all visits for the duration of the study.
- •All female subjects of childbearing potential (not surgically sterile or postmenopausal) and male subjects with female partners of childbearing potential must agree to use effective contraception (such as implants, injectables, combined oral contraceptives, intrauterine device, sexual abstinence, vasectomy or vasectomized partner) for the duration of the study (84 days).
- •Fitzpatrick Skin Type (FST I-VI) assessment and documentation at baseline. Subjects of all FST categories (I-VI) are eligible, and the enrollment strategy will ensure that the full range of FST is represented in the study population (10% minimum enrollment in each FST sub-category).
排除标准
- •DSW size of > 310 cm2
- •Calculated glomerular filtration rate (GFR) <60 ml/min
- •Hypocalcemia defined as serum corrected calcium of <8.0 mg/dl
- •Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 times the upper limit of normal (ULN).
- •Serum Creatinine > 2.0 mg/dL.
- •Pregnant, lactating or nursing women.
- •Unable to provide consent.
- •Prior adverse reaction or known sensitivity to silver or gallium.
- •Enrollment in another interventional trial using a systemic therapeutic within 30 days prior to enrollment for this study.
- •Presumed impairment of wound healing as with prescription drugs or medical diagnoses that have potential to impair wound healing at the discretion of clinical investigator, e.g., cancer, transplant status, autoimmune disease, severe malnutrition, etc.
- •Any diagnosis with concern for 30-Day mortality.
- •Any condition that might impair the evaluation of subject safety or that in the investigator opinion would interfere with study requirements.
结局指标
主要结局
Adverse event occurrence, including infection
时间窗: From enrollment to Day 84
Incidence of wound closure defined as skin re-epithelialization without drainage or dressing requirements, confirmed at two consecutive study visits 2 weeks apart (Day 14 and Day 28)
时间窗: From enrollment to Day 84
次要结局
- Debridement - yes or no(Enrollment to Day 84)
- Pain as measured using a 10-point VAS(Enrollment to Day 84)
- Itching as assessed using a 10-point VAS(Enrollment to Day 84)
- Time, in days, to complete DSW closure(Enrollment to Day 84)
- Percentage of donor site wound closure at Day 9(Enrollment to Day 9)
- Quality of healing, evaluated using the Patient Observer Scare Assessment Scale (POSAS)(Day 84)
- Durability of wound closure at 12 weeks(Day 84)