Vicryl Rapide Versus Nonabsorbable Suture

Part of paid clinical trials in Fresno, California.

Sponsor
University of California, San Francisco
Study ID
NCT04056013
Status
Recruiting

Conditions

  • Traumatic Lacerations

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vicryl Rapide absorbable suture — DEVICE
    In general, most laceration repair has been done with sutures on the surface of the skin that do not break down and fall off on their own, so after enough days have passed for the laceration to heal properly, the patient needs to return to the ED to have the sutures removed by cutting them off. These sutures are called "nonabsorbable". Some newer sutures have been designed to slowly dissolve on their own and fall out over several days. These are called "absorbable" sutures. You do not normally need to return to the ED for removal as these should slowly dissolve and fall out on their own.

Study Details

This will be a prospective, randomized controlled trial assessing noninferiority of Vicryl Rapide compared to nonabsorbable suture. The study will be conducted in the Community Regional Medical Center emergency department (ED). The aim of this study, then, is to prospectively determine if 3-month cosmesis for traumatic laceration repair of trunk/extremity lacerations in adult patients with Vicryl Rapide is noninferior to nonabsorbable suture.

Key Dates

Start date
Sep 26, 2019
Status verified
Feb 2025
Primary completion
Sep 1, 2028
Completion
Jan 31, 2029

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Absorbable
    Wound repaired with Vicryl Rapide absorbable suture
  • No Intervention: Nonabsorbable
    Wound repaired with traditional nonabsorbable suture

Primary Outcome Measure

The two treatments will be compared by a noninferiority test [ Time Frame: 3-Month ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Community Regional Medical CenterFresnoCalifornia93721
Brian F Chinnock, MD
559-499-6440
Jannet Castaneda, BA
559-499-6435
Community Regional Trauma and Burn CenterFresnoCalifornia93721
Brian Chinnock, MD
559-499-6400
Jannet Castaneda
559-499-6435
Brian Chinnock, MD (PRINCIPAL_INVESTIGATOR)

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