Clinical trial NCT04056013: Vicryl Rapide Versus Nonabsorbable Suture
Official title: Vicryl Rapide Versus Nonabsorbable Suture in Repair of Simple Traumatic Extremity and Trunk Lacerations in Adult Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Lacerations
Keywords: Traumatic lacerations
Vicryl Rapide
nonabsorbable suture
Suture
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Central California Faculty Medical Group
First posted: 2019-08-14
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients meeting eligibility criteria will be randomized to treatment with either Vicryl Rapide or nonabsorbable suture. To ensure comparable numbers patients with buried sutures, there will also be 1 block of 8 patients that is randomized for absorbable or nonabsorbable closure in patients who are receiving buried sutures.
Primary purpose: TREATMENT

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).

Eligibility 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)

Primary outcomes:
measure: The two treatments will be compared by a noninferiority test
timeFrame: 3-Month
Secondary outcomes:
measure: Percentage of patients needing further treatment
timeFrame: 30-days
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Community Regional Medical Center
state: California
city: Fresno
country: United States
facility: Community Regional Trauma and Burn Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Brian Chinnock, MD
role: PRINCIPAL_INVESTIGATOR
References:
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