What this study is
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.
What's being tested
- Vicryl Rapide absorbable suture
Intervention · 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
- Official title
- Vicryl Rapide Versus Nonabsorbable Suture in Repair of Simple Traumatic Extremity and Trunk Lacerations in Adult Patients
- Sponsor
- University of California, San Francisco
- Conditions
- Traumatic Lacerations
- Enrolling
- 96 people
- Starts
- 2019-09-26
- Est. completion
- 2029-01-31
- Design
- Triple-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openContact for every open site
- Jannet Castaneda, BA · Contact559-499-6435jcastaneda@fresno.ucsf.edu
Community Regional Medical Center
Fresno, California, United States
- Brian F Chinnock, MD · Contact559-499-6440bchinnock@fresno.ucsf.edu
RecruitingCommunity Regional Trauma and Burn Center
Fresno, California, United States
- Brian Chinnock, MD · Contact559-499-6400brian.chinnock@ucsf.edu
- Brian Chinnock, MD · Principal investigator
Recruiting
Study team
Sponsor
University of California, San Francisco
Study ID 2019062
Principal investigator
Brian Chinnock, MD
University of California, San Francisco
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.