NCT00959374

Evaluation of Dermal Closure With an Absorbable Barbed Suture as Compared to a Conventional Absorbable Suture

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 229 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Ptosis
• Obesity

Interventions

Type	Name	Description
DEVICE	V-Loc 180/90 Wound Closure Device	Barbed absorbable suture
DEVICE	3-0 Monocryl Absorbable Sutures	3-0 Monocryl Absorbable Suture (non-barbed)

Timeline

• Start date: 2009-08-01
• Primary completion: 2011-05-01
• Completion: 2012-02-01
• First posted: 2009-08-14
• Last updated: 2013-04-17
• Results posted: 2013-04-17

Locations

8 sites across 2 countries: United States, Germany