A Multi-Center, Prospective, Open-label, Randomized, Non-inferiority Study of 3M™ Topical Tissue Adhesive Versus Commercially Available Tissue Adhesive for the Closure of Traumatic Lacerations and Surgical Incisions
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 78
- 主要终点
- Apposition of Skin Edges
研究概览
简要总结
The purpose of this study is to generate safety and performance data for 3M™ Topical Tissue Adhesive. Enrolled subjects with qualifying trauma lacerations or surgical incisions will be randomized to receive 3M™ Topical Tissue Adhesive or Histoacryl® Blue Topical Skin Adhesive with follow-up visits at 10 days and 30 days after application of tissue adhesive.
详细描述
This is a multicenter, prospective, open-label, randomized, non-inferiority study that will include 452 randomized Subjects requiring closure of superficial lacerations, clean traumatic lacerations, low-tension incisions, or surgical incisions from minimally invasive surgeries. The study will enroll Subjects from up to 10 sites in the USA.
Subjects will be seen during Screening (no more than 10 days before application of tissue adhesive), on the day in which skin edges of wound(s) are reapproximated and tissue adhesive is applied (Day 0), 10 days after application of the tissue adhesive, and 30 days after application of the tissue adhesive.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is at least 22 years of age on the date of informed consent
- •Subject or Subject's legally authorized representative can provide informed consent
- •Subject is willing and able to attend all scheduled study visits and abide by all study restrictions
- •Subject has a single laceration that is ≤ 100 mm (10.0 cm) in length or up to 4 surgical incision(s), each ≤ 100 mm (10.0 cm) in length, defined as Class I or Class II wound(s), in which the use of a tissue adhesive (in combination with but not replacing deep dermal sutures, if applicable) is appropriate, including the following:
- •surgical incision from a minimally invasive surgery
- •low tension incision
- •superficial laceration
- •clean, traumatic laceration with edges that can be easily approximated
排除标准
- •Subject has a positive pregnancy test within 48 hours prior to randomization at Day 0 or is lactating prior to randomization at Day 0
- •Subject is found to have any of the following before randomization:
- •a known peripheral vascular disease
- •a history of hypertrophic scarring and/or keloids
- •any Class III or Class IV wounds
- •uncontrolled diabetes mellitus (DM), defined as HbA1C ≥ 10% within 90 days before screening. If HbA1C data is unavailable or the Subject presents in an emergency situation, uncontrolled DM will be defined as blood glucose ≥ 250 mg/dL
- •a known blood clotting disorder
- •immunocompromised
- •a known systemic or local bacterial, viral, or fungal infection
- •critical injury
- •condition(s) that in the opinion of the Investigator will impact study results (eg, hemophilia or autoimmune disorder) or the ability of the Subject to remain compliant with study procedures, study restrictions, and/or visits
- •Subject has a known hypersensitivity or allergy to any of the components of study products (eg, polyoxamides or cyanoacrylates)
- •Subject is concurrently participating in or was enrolled in another interventional clinical study within 30 days of randomization
- •Subject has a laceration or incision that is > 100 mm (10 cm) in length
- •Subject has any incision that is within 5 cm of any adjacent incision
- •Subject has one of the following:
- •a "burst" or stellate laceration
- •wound with exposed bone
- •wound with suspected skin edge ischemia due to extensive undermining
- •wound requiring drain(s)
- •wound requiring a conventional closure method (eg, subcuticular/intradermal suture, staples, adhesive strips) OR subcuticular stitch placement for enhanced wound support (ie, to further minimize tension)
- •Subject has a wound with any of the following etiologies:
- •human or animal bite
- •prolonged pressure (ie, decubitus)
- •Subject has a wound in any of the following anatomical locations:
- •on mucosal surfaces or across mucocutaneous junctions (eg, oral cavity, lips)
- •in or around the eyes
- •an anatomical area that is under tension or over a joint
- •on an area that may be regularly exposed to body fluids or with dense natural hair present (eg, scalp)
结局指标
主要结局
Apposition of Skin Edges
时间窗: 10 days
Percentage of subjects with wounds with 100% apposition of skin edges at 10 days after application of tissue adhesive
次要结局
- Tissue Adhesive Remaining(10 days)
- Apposition of Skin Edges(30 days)