Permanent Versus Delayed-Absorbable Monofilament Suture

Completed

Conditions studied: Hysterectomy, Sacrocolpopexy

In brief

This is an extension study of a prospective, multicenter, randomized, single-blind trial whose purpose is to compare mesh-related complications and effectiveness of pelvic organ prolapse (POP) repair in women undergoing minimally-invasive total hysterectomy and sacrocolpopexy (SCP) with a light-weight polypropylene mesh (Upsylon™ y-mesh) using permanent (polytetrafluoroethylene, Gore-Tex) versus delayed absorbable monofilament (polydioxanone, PDS) suture for vaginal mesh attachment through at least 3 years after surgery.

Key facts

Study ID

NCT04506177

Run by

Wake Forest University Health Sciences

People needed

200

Starts

2020-07-01

Expected to finish

2023-04-05

Last updated by the study team

2024-01-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients who have participated in the PACT Study Trial (Permanent Versus Delayed-absorbable Monofilament Suture for Vaginal Graft Attachment During Minimally-invasive Total Hysterectomy and Sacrocolpopexy: A Randomized Clinical Trial)

You may not qualify if…

• Patient is not willing to sign consent
• Patient does not want to fill-out questionnaires

Where it is running

• Augusta University — Augusta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Atrium Health — Charlotte, North Carolina, United States
• Wake Forest Health Sciences — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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