BandGrip® Closure of Surgical Incisions Following Arthroscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Incidence of complete would closure
研究概览
简要总结
A single-arm, prospective, unblinded, post marketing, single center study using BandGrip to close incisions post arthroscopic shoulder surgery.
详细描述
The study objective is to assess the ease of incision closure, the cosmetic appearance of the wounds on follow-up, and general subject satisfaction with the appearance of the healed incisions following use of BandGrip. Up to 25 subjects will be enrolled at a single center.
Subjects who have undergone arthroscopic surgery of the shoulder and require closure of one or two skin puncture sites will be enrolled. Following incision closure subjects will be seen at the time of BandGrip removal (approximately 7-14 days after closure) and at 30 days for assessment of the incisions.
The incidence of wound closure for each treated puncture site, defined as continuous approximation of wound margins from the time of wound closure until the day of removal of the wound closure device without dehiscence or need for reclosure.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is ≥ 18 years of age.
- •Subject had an arthroscopic shoulder procedure and has at least two skin incisions that are assessed as requiring temporary approximation of the skin edges.
- •The length of the subject's surgical incisions is less than or equal to 1.5 inches.
- •Subject must be willing to follow instructions for wound care provided by investigator and refrain from picking at the treatment device, applying topical medications to the wound, and swimming or soaking in a tub until the wound closure device is removed.
- •Subject agrees to return for all required follow-up evaluations.
- •Subject is able to comprehend and give informed consent for participation in this study.
排除标准
- •Subject has a recent history of bleeding, coagulation, and/or clotting disorders.
- •Subject is on dialysis.
- •Subject has a history of inflammatory and/or allergic diseases or conditions of the skin involving the location of the incisions (e.g., psoriasis, Eczema, or dermatitis).
- •Subject has a history of drug abuse.
- •Subject has a history of chronic use of oral steroids or immunosuppressants.
- •Subject has known personal or family history of keloid or hypertrophic scarring.
- •Subject has a history of abnormal wound healing.
- •Subject's incisions are in a high skin tension area.
- •Subject has a known allergy to BandGrip material (polycarbonate).
- •Subject has a known cognitive or psychiatric disorder.
- •Subject has an incision at site of active rash/skin lesion making evaluation difficult.
研究组 & 干预措施
BandGrip
Topical skin closure device
干预措施: BandGrip skin closure device (Device)
结局指标
主要结局
Incidence of complete would closure
时间窗: 30 days post treatment
complete approximation of wound margins from the time of wound closure until the day of removal of the wound closure device without dehiscence or need for reclosure.
次要结局
- Physician Satisfaction with cosmetic appearance of healed incision(10 and 30 days post surgery)
- Time to closure and removal of wound closure device(at surgical procedure and 10 days)
- Incision Cosmesis(10 and 30 days post closure)
- Incidence of partial wound apposition(10 and 30 days post closure)
- Subject Satisfaction with cosmetic appearance of healed incision(10 and 30 days post surgery)
- Adverse events(30 days post surgery)