Vaginal Cuff Closure Time Using Unidirectional Barbed Suture in Robotic Hysterectomy

University of Tennessee

Status: Unknown

Conditions: Disease (or Disorder); Gynecological

Treatments: Device: polyglactin 910 (Vicryl); Device: Unidirectional Barbed Suture (V-Loc)

Study type: Interventional

Funder types: Other

Identifiers

NCT01814579

12-14 (Other Identifier)

11-01423-FB

Details and patient eligibility

About

This study is designed to determine if using the V-Loc Wound Closure System expedites operative time in robotic hysterectomy.

Full description

Currently both traditional continuous smooth suture and unidirectional barbed suture techniques are standard of care in robotic hysterectomy and the decision of which to use is at the discretion of the surgeon. By using unidirectional barbed suture in which no knot tying is required, wound closure time may be decreased resulting in decreased operative time. This study was created to compare vaginal cuff closure times using these two techniques.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women being scheduled to have a robotic hysterectomy for benign or malignant disease by the West Clinic Gynecology-Oncology Physicians
• Females age 18+

Exclusion criteria

• Patients receiving ongoing radiation therapy to the pelvis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

V-Loc Vaginal Cuff Closure

Experimental group

Description:

Patients in this arm will receive vaginal cuff closure with unidirectional barbed suture at time of their robotic hysterectomy.

Treatment:

Device: Unidirectional Barbed Suture (V-Loc)

Vicryl Vaginal Cuff Closure

Active Comparator group

Description:

Patients enrolled in this arm will have their vaginal cuff closed with polyglactin 910 (Vicryl) at the time of their robotic hysterectomy.

Treatment:

Device: polyglactin 910 (Vicryl)