A Prospective, Randomized Study to Evaluate Dermal Closure With an Absorbable Barbed Suture (V-Loc 180 Absorbable Wound Closure Device or V-Loc 90 Absorbable Wound Closure Device) as Compared to a Conventional Absorbable Suture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 229
- 试验地点
- 8
- 主要终点
- Total Dermal Closure Time
研究概览
简要总结
The objective of this study is to evaluate the use of an absorbable barbed suture as compared to a conventional absorbable suture when used for dermal closure during certain body contouring procedures.
详细描述
One of the greater common challenges of a surgical procedure is to effectively and efficiently close wounds across various levels of muscle, fat, fascia and/or skin.
Surgical sutures continue to be the material of choice for wound closure. However, complications of sutures are those associated with tying knots to secure the suture. Examples of associated suture complications, although not comprehensive, include knot breakage and slippage, suture extrusion or spitting, infection, ischemia and scarring, reduced wound strength and inflammation and dehiscence.
Both interrupted and continuous suture patterns require knots for suture line security when conventional suture constructs are used. Barbed sutures are designed to eliminate the need for tying knots during closure, thus ameliorating the detrimental aspects of knots.
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
- 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
- 是
入选标准
- •Subject must be 18 years of age or older.
- •Subject must be in good overall health.
- •Subject must be scheduled for individual or combined abdominoplasty, reduction mammaplasty, or mastopexy, other than concentric mastopexy, crescent mastopexy, or mastopexy with implants.
- •Subject must be willing to participate in the study, comply with study requirements, follow-up schedule, and give written informed consent.
排除标准
- •Subject is pregnant or breast-feeding.
- •Subject has active infectious collagen diseases (i.e. scleroderma) or any other condition that would interfere with wound healing.
- •Subject has significant anatomic asymmetry that creates markedly different wound tension and/or geometry between the right and left side.
- •Subject is allergic to the test suture made of glycolide and trimethylene carbonate or the control suture made of glycolide and epsilon-caprolactone.
- •Subject has a BMI ≥
- •Subject has diabetes requiring medication for glycemic control.
- •Subject has a fever (temperature > 38ºC), active skin infection or systemic infection at the time of surgery.
- •Subject underwent chemotherapy or radiation within the last 6 months.
- •Subject has a history of keloid or hypertrophic scar formation or other dermatologic conditions known to impair wound healing.
- •Subject has a history of alcohol or drug abuse within 6 months prior to screening.
- •Subject has a history of immunosuppressive drug use, including steroids, within the last 6 months.
- •Subject has had a documented breast imaging finding or physical breast exam finding requiring further evaluation prior to elective surgery.
- •Subject has not had a mammogram within the last 12 months, for female patients ≥ 40 years of age scheduled for mastopexy or reduction mammaplasty.
- •Subject is taking part in another clinical study which directly relates to this study. If, however, the subject is taking part in a non-related study, the investigator should contact the Study Manager for advice.
- •The investigator determines that the subject should not be included in the study for reasons not already specified.
研究组 & 干预措施
V-loc and Monocryl
Subjects served as their own control, and they were randomized to receive an intervention of a standard closure using 3-0 Monocryl™ on one side of the body and the test closure device, V-Loc 180/90, on the other side. The standard closure technique was agreed on by study investigators for control side, and included mandatory closure of the deep dermal layer with interrupted 3-0 Monocryl™ sutures, spaced no further than 2 cm apart, followed by closure of the intradermal layer with running 3-0 Monocryl™ sutures. The test closure side, closure of the deep dermal layer was optional. If deep dermal sutures were used, interrupted 3-0 Monocryl™ sutures were required to be placed no closer than 5 cm apart followed by closure of the intradermal layer with test device, V-Loc 180/90.
干预措施: 3-0 Monocryl Absorbable Sutures (Device)
V-loc and Monocryl
Subjects served as their own control, and they were randomized to receive an intervention of a standard closure using 3-0 Monocryl™ on one side of the body and the test closure device, V-Loc 180/90, on the other side. The standard closure technique was agreed on by study investigators for control side, and included mandatory closure of the deep dermal layer with interrupted 3-0 Monocryl™ sutures, spaced no further than 2 cm apart, followed by closure of the intradermal layer with running 3-0 Monocryl™ sutures. The test closure side, closure of the deep dermal layer was optional. If deep dermal sutures were used, interrupted 3-0 Monocryl™ sutures were required to be placed no closer than 5 cm apart followed by closure of the intradermal layer with test device, V-Loc 180/90.
干预措施: V-Loc 180/90 Wound Closure Device (Device)
结局指标
主要结局
Total Dermal Closure Time
时间窗: At time of surgery
In calculating the total dermal closure time, only the intradermal closure time is used for those subjects that did not have the deep dermal layer closed.
次要结局
- Cosmesis(12 weeks)