A Prospective, Randomized, Single-blinded Study to Assess the Incidence of Wound Complications Following Total Knee and Hip Arthroplasty in Patients Treated With Two Different Types of Topical Skin Adhesive
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 310
- 试验地点
- 7
- 主要终点
- All time wound complications
研究概览
简要总结
This prospective, randomized, controlled, blinded clinical trial is designed to assess the incidence of all time and all types of wound-related complications following total joint arthroplasty (TJA) when two different types of topical skin adhesives are used to close the incision.
详细描述
The aim of this study is to assess the incidence of incision healing complications in patients undergoing primary total knee replacement and total hip replacement treated with either Omnibond or Dermabond advanced topical skin adhesive. All patients undergoing a primary, elective TKA and THA at participating centers that sign a consent form will be followed up for a period of up to 30 days to determine if there are any incision healing complications.
Secondary outcomes will include dry time of the topical skin adhesive, user satisfaction, patient satisfaction, and incidence of adverse events.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient ≥18 years old
- •Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females
- •Subjects scheduled to undergo primary, elective total knee arthroplasty or total hip arthroplasty
- •Subjects provide informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information
- •Subjects deemed able to understand and comply with study visit schedule and procedures
排除标准
- •Local skin conditions such as dermatitis, eczema, psoriasis that, in the opinion of the investigator, will make it difficult to assess wound complications or local skin reactions following surgery
- •Pregnant, lactating females, or females of childbearing potential not willing to practice an effective method of contraception
- •Active or previous infection in the skin or the knee or hip to be operated, evidence of gangrene
- •Subjects who have participated in this trial previously and who were withdrawn
- •Subjects with known allergies to product components including cyanoacrylate, formaldehyde, benzalkonium chloride or have known allergies or skin sensitivity to the Convatec Aquacel dressing.
- •Inability or refusal to provide informed consent or follow study and wound care instructions
结局指标
主要结局
All time wound complications
时间窗: From surgery to 30 days post-op
any occurrence of a wound-related complication following surgery
次要结局
- Dry time(From time of initial product placement on the skin to when the entire application is dry to the touch with a gloved hand)
- User satisfaction with study treatment(Up to 1 hour after study product application)
- Subject satisfaction with study treatment(Up to 14 days following surgery)