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Vicryl Rapide Versus Nonabsorbable Suture

Primary Purpose

Traumatic Lacerations

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vicryl Rapide absorbable suture
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Lacerations focused on measuring Traumatic lacerations, Vicryl Rapide, nonabsorbable suture, Suture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Community Regional Medical CenterRecruiting
  • Community Regional Trauma and Burn CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Absorbable

Nonabsorbable

Arm Description

Wound repaired with Vicryl Rapide absorbable suture

Wound repaired with traditional nonabsorbable suture

Outcomes

Primary Outcome Measures

The two treatments will be compared by a noninferiority test
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

Percentage of patients needing further treatment
Follow-up call to determine if patient required further treatment beyond routine care

Full Information

First Posted
August 12, 2019
Last Updated
April 13, 2023
Sponsor
University of California, San Francisco
Collaborators
Central California Faculty Medical Group
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1. Study Identification

Unique Protocol Identification Number
NCT04056013
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2019 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Central California Faculty Medical Group

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Lacerations
Keywords
Traumatic lacerations, Vicryl Rapide, nonabsorbable suture, Suture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Absorbable
Arm Type
Active Comparator
Arm Description
Wound repaired with Vicryl Rapide absorbable suture
Arm Title
Nonabsorbable
Arm Type
No Intervention
Arm Description
Wound repaired with traditional nonabsorbable suture
Intervention Type
Device
Intervention Name(s)
Vicryl Rapide absorbable suture
Intervention Description
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 Information:
Title
The two treatments will be compared by a noninferiority test
Description
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.
Time Frame
3-Month
Secondary Outcome Measure Information:
Title
Percentage of patients needing further treatment
Description
Follow-up call to determine if patient required further treatment beyond routine care
Time Frame
30-days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Chinnock, MD
Phone
559-499-6440
Email
bchinnock@fresno.ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jannet Castaneda, BA
Phone
559-994-5893
Email
jcastaneda@fresno.ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Chinnock, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Community Regional Medical Center
City
Fresno
State/Province
California
ZIP/Postal Code
93721
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian F Chinnock, MD
Phone
559-499-6440
Email
bchinnock@fresno.ucsf.edu
First Name & Middle Initial & Last Name & Degree
Jannet Castaneda, BA
Phone
559-499-6435
Email
jcastaneda@fresno.ucsf.edu
Facility Name
Community Regional Trauma and Burn Center
City
Fresno
State/Province
California
ZIP/Postal Code
93721
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Chinnock, MD
Phone
559-499-6400
Email
brian.chinnock@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Jannet Castaneda
Phone
559-499-6435
Email
jcastaneda@fresno.ucsf.edu
First Name & Middle Initial & Last Name & Degree
Brian Chinnock, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan.
Citations:
PubMed Identifier
15231459
Citation
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Results Reference
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PubMed Identifier
1106807
Citation
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Results Reference
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PubMed Identifier
8523317
Citation
Edwards DJ, Elson RA. Skin closure using nylon and polydioxanone: a comparison of results. J R Coll Surg Edinb. 1995 Oct;40(5):342-3.
Results Reference
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PubMed Identifier
2660322
Citation
Lundblad R, Simensen HV, Wiig JN, Niels Gruner OP. [Skin closure. A prospective randomized study]. Tidsskr Nor Laegeforen. 1989 Apr 30;109(12):1307-9. Norwegian.
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Citation
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PubMed Identifier
15258862
Citation
Holger JS, Wandersee SC, Hale DB. Cosmetic outcomes of facial lacerations repaired with tissue-adhesive, absorbable, and nonabsorbable sutures. Am J Emerg Med. 2004 Jul;22(4):254-7. doi: 10.1016/j.ajem.2004.02.009.
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PubMed Identifier
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Citation
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PubMed Identifier
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Luck R, Tredway T, Gerard J, Eyal D, Krug L, Flood R. Comparison of cosmetic outcomes of absorbable versus nonabsorbable sutures in pediatric facial lacerations. Pediatr Emerg Care. 2013 Jun;29(6):691-5. doi: 10.1097/PEC.0b013e3182948f26.
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Citation
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Vicryl Rapide Versus Nonabsorbable Suture

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