Comparing Vicryl Rapide to Nonabsorbable Suture for Laceration Repair
Vicryl Rapide Versus Nonabsorbable Suture in Repair of Simple Traumatic Extremity and Trunk Lacerations in Adult Patients
This study is testing if a new type of absorbable suture works just as well as traditional nonabsorbable sutures for closing cuts in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 2 sites (Fresno, California and 1 other locations) |
| Trial ID | NCT04056013 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective, randomized controlled trial designed to assess the noninferiority of Vicryl Rapide absorbable sutures compared to traditional nonabsorbable sutures for repairing traumatic lacerations. Conducted in the emergency department of Community Regional Medical Center, the study will enroll adult patients with single lacerations on the trunk or extremities that require suture closure. Participants will be screened for eligibility and randomized to receive either Vicryl Rapide or nonabsorbable sutures, with outcomes measured based on the cosmetic appearance of the healed laceration after three months.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older with a single traumatic laceration on the trunk or extremities that is greater than 2 cm in length and requires suture closure.
Not a fit: Patients with high infection potential, complex wounds, or those requiring special considerations such as keloid formation or chronic steroid use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence that Vicryl Rapide sutures are as effective as nonabsorbable sutures, potentially improving patient comfort and healing times.
How similar studies have performed: Other studies have shown promising results with absorbable sutures in similar contexts, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Fresno, California and 1 other locations
- Community Regional Medical Center — Fresno, California, United States (Recruiting)
- Community Regional Trauma and Burn Center — Fresno, California, United States (Recruiting)
Study contacts
- Principal investigator: Brian Chinnock, MD — University of California, San Francisco
- Study coordinator: Brian Chinnock, MD
- Email: bchinnock@fresno.ucsf.edu
- Phone: 559-499-6440
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.