Recruiting

Vicryl Rapide vs. Nonabsorbable

Sponsor:

UCLA

Code:

NCT04056013

Conditions

Traumatic Lacerations

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Vicryl Rapide absorbable suture

Study Details

Brief summary:

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.

Conditions

Traumatic Lacerations

Study ID

NCT04056013

Start date

Sep 26, 2019

Status verified date

Feb, 2025

Completion date

Jan 31, 2029

Anticipated

Primary completion date

Sep 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient 18-years or older

  • single laceration on trunk or extremity requiring suture closure
  • laceration length > 2-cm
  • wound to be closed with simple interrupted sutures

Exclusion Criteria:

  • High infection potential
  • Must have one of the following:

  • puncture wound

  • -highly contaminated
  • devitalized tissue requiring sharp debridement

  • -bite wounds
  • -> 24-hours-old

  • Low likelihood of good cosmesis
  • Must have one of the following:

-dehisced wound from previous wound closure
  • -wound
  • -crush wound
  • -soft tissue deficit limiting complete apposition of wound edges
  • -significant overlying macerated/abraded tissue

  • Underlying tendon or cartilage involvement

-Wound greater than 10 cm in length
  • Significant wound healing problems
  • Must have one of the following:

  • keloid formers
  • chronic steroid use
  • other: ______________________ -Inability to give written consent
  • Must have one of the following:

  • non-English or non-Spanish speaker

  • altered mental status
  • incarcerated patient
  • No telephone number or unlikely to return for 3-month follow-up
  • Must have one of the following:

  • homeless
  • psychiatric patient,
  • nursing home patient,
  • other: ______________________
  • More than one laceration needing suture repair on trunk or extremity (i.e. appropriate to proceed if second laceration is to face/neck)

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Absorbable

Wound repaired with Vicryl Rapide absorbable suture

no intervention: Nonabsorbable

Wound repaired with traditional nonabsorbable suture

Interventions

Vicryl Rapide absorbable suture

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Brian Chinnock, MD

559-499-6440bchinnock@fresno.ucsf.edu

Jannet Castaneda, BA

559-994-5893jcastaneda@fresno.ucsf.edu

Locations

Community Regional Medical Center

Recruiting

Fresno, California, United States, 93721

Contacts

Brian F Chinnock, MD

559-499-6440bchinnock@fresno.ucsf.edu

Jannet Castaneda, BA

559-499-6435jcastaneda@fresno.ucsf.edu

Community Regional Trauma and Burn Center

Recruiting

Fresno, California, United States, 93721

Contacts

Brian Chinnock, MD

559-499-6400brian.chinnock@ucsf.edu

Jannet Castaneda

559-499-6435jcastaneda@fresno.ucsf.edu

Principal Investigator:

Brian Chinnock, MD

More Information

Sponsor

University of California, San Francisco

Last update posted

Feb 28, 2025

Last verified

Feb, 2025

Keywords

  • Traumatic lacerations
  • Vicryl Rapide
  • nonabsorbable suture
  • Suture

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2025-02-28.