Vicryl Rapide Versus Nonabsorbable Suture

Not Applicable

Recruiting

• Conditions: Traumatic Lacerations
• Interventions: Device: Vicryl Rapide absorbable suture

• Registration Number: NCT04056013
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Study flyers will be posted in all doc boxes to ensure all ED personnel is aware of ongoing studies. Initial ED history and physical examination (standard procedure). Provider identifies patient who is felt to require suture closure. Provider will contact study staff that approved to consent patient to consent the patient for the study. After identification of a patient who meets inclusion criteria, the patient will be screened for exclusion criteria by the investigators using a preprinted form on the outside of the study envelope. If the patient has an exclusion criterion, this will be noted on this preprinted form and the form will be saved for further data analysis without any patient identifiers, and the patient will not be enrolled in the study. If the patient does not have exclusion criteria, the enrollment envelope will be opened and he/she will undergo the written consent process. After written consent is complete, the randomization envelope is opened. There will be a question asking if buried sutures will be needed as the group of patients needing buried sutures will have their own randomized packets to ensure a similar amount of buried suture patients are in both the Vicryl Rapide and nonabsorbable suture closure group. The study staff will then gather the following information regarding wound characteristics: Measure the length and width of the laceration, laceration location, presence of contamination, and if it is simple linear. The laceration will then be prepped for closure using whatever cleaning or anesthesia is felt to be appropriate by the practitioner. Suture closure will then occur with either Vicryl Rapide or nonabsorbable suture according to randomization direction in the envelope. After laceration closure, the practitioner will also write down on this paper the suture size and, for the nonabsorbable group, the type of suture used. The practitioner performing suture closure will also write down whether he/she is the nurse practitioner (NP), physician assistant (PA), emergency medicine (EM) faculty or EM resident. Patients will be given preprinted discharge instructions appropriate to whether Vicryl Rapide or nonabsorbable suture was used that gives information such as precautions for infection, information about how to do the 3-month follow-up, research coordinator contact information, and date to return for suture removal in the nonabsorbable group.

At 30 days post enrollment, the patient will receive a call from trained Institutional review board (IRB) approved study personnel. The pre-printed scripted form will ask questions to determine if the patient had any complications including infection, dehiscence, and, in the absorbable suture group, whether a return visit was needed to have the sutures removed.

At 30 days post enrollment, study personnel will also do a chart review collecting the following elements: Patient's age, ethnicity, gender, comorbid conditions including diabetes mellitus, renal insufficiency, liver disease, and immunodeficiency, ED vital signs, and whether patient was admitted or treated as outpatient for the index visit. The chart will also be reviewed examining for any revisit to the ED during those 30 days with any of the complications listed in the previous paragraph.

At three-months post enrollment, the research coordinator will work with the patient to arrange an appointment to take pictures of the wound. The patient will have their follow-up visit done at the Clinical Research Center at the University of California, San Francisco (UCSF) Fresno building. The photographs will be taken by study personnel with instructions on how to take these. At this time, the patient would be provided with a gift card and log book would be signed by the patient. The photographs are then prepared for submission to the plastic surgeon who will be evaluating them. Photographs will not have any patient identifiers other than a study number, and would be labeled with the anatomic area. The plastic surgeon, who is a blinded study staff to the study hypothesis, then assesses the cosmesis of the wound on a 100-mm visual analog scale (VAS).

Study Timeline

• Study First Submitted: 2019-08-12
• Study First Submitted QC: 2019-08-12
• Study First Posted: 2019-08-14
• Study Start: 2019-09-26
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-13
• Last Update Posted: 2023-04-18
• Primary Completion: 2025-09-01
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Absorbable	Vicryl Rapide absorbable suture	Wound repaired with Vicryl Rapide absorbable suture

Primary Outcome Measures

Name	Time	Method
The two treatments will be compared by a noninferiority test	3-Month	For sample size determination, based on a previous study, we expected that the standard deviation (SD) for cosmesis scores would be 15 mm.10 With the minimum clinically important cosmetic difference of 12-mm, and assuming an alpha value of 0.05 and statistical power of 90%, we estimated that we would need 46 subjects in each group for a total of 96 patients (assuming a dropout rate of 40%), to detect this 12-mm difference in the groups' mean cosmesis scores.

Secondary Outcome Measures

Name	Time	Method
Percentage of patients needing further treatment	30-days	Follow-up call to determine if patient required further treatment beyond routine care

Trial Locations

Locations (2)

Community Regional Medical Center; 🇺🇸 Fresno, California, United States

Community Regional Trauma and Burn Center; 🇺🇸 Fresno, California, United States