Vicryl Rapide Versus Nonabsorbable Suture

NCT04056013 | Recruiting DMC FDA Device

• 1 other identifier: 2019062
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

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.

Conditions

Traumatic Lacerations

Keywords

Traumatic lacerations; Vicryl Rapide; nonabsorbable suture; Suture

Outcome Measures

Primary Outcomes (1)

• 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.

  3-Month

Secondary Outcomes (1)

• Percentage of patients needing further treatment

  30-days

Study Arms (2)

Absorbable

ACTIVE COMPARATOR

Wound repaired with Vicryl Rapide absorbable suture

Device: Vicryl Rapide absorbable suture

Nonabsorbable

NO INTERVENTION

Wound repaired with traditional nonabsorbable suture

Interventions

Vicryl Rapide absorbable suture 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.

Absorbable

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• Central California Faculty Medical Group: collaborator

Study Sites (2)

Community Regional Medical Center

Fresno, California, 93721, United States

RECRUITING

Community Regional Trauma and Burn Center

Fresno, California, 93721, United States

RECRUITING

Related Publications (12)

• Karounis H, Gouin S, Eisman H, Chalut D, Pelletier H, Williams B. A randomized, controlled trial comparing long-term cosmetic outcomes of traumatic pediatric lacerations repaired with absorbable plain gut versus nonabsorbable nylon sutures. Acad Emerg Med. 2004 Jul;11(7):730-5. doi: 10.1197/j.aem.2003.12.029.

  PMID: 15231459 BACKGROUND

• Mouzas GL, Yeadon A. Does the choice of suture material affect the incidence of wound infection? A comparison of dexon (polyglycolic acid) sutures with other commonly used sutures in an accident and emergency department. Br J Surg. 1975 Dec;62(12):952-5. doi: 10.1002/bjs.1800621207.

  PMID: 1106807 BACKGROUND

• 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.

  PMID: 8523317 BACKGROUND

• 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.

  PMID: 2660322 BACKGROUND

• Murphy PG, Tadros E, Cross S, Hehir D, Burke PE, Kent P, Sheehan SJ, Colgan MP, Moore DJ, Shanik GD. Skin closure and the incidence of groin wound infection: a prospective study. Ann Vasc Surg. 1995 Sep;9(5):480-2. doi: 10.1007/BF02143863.

  PMID: 8541198 BACKGROUND

• 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.

  PMID: 15258862 BACKGROUND

• Luck RP, Flood R, Eyal D, Saludades J, Hayes C, Gaughan J. Cosmetic outcomes of absorbable versus nonabsorbable sutures in pediatric facial lacerations. Pediatr Emerg Care. 2008 Mar;24(3):137-42. doi: 10.1097/PEC.0b013e3181666f87.

  PMID: 18347489 BACKGROUND

• 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.

  PMID: 23714755 BACKGROUND

• Tejani C, Sivitz AB, Rosen MD, Nakanishi AK, Flood RG, Clott MA, Saccone PG, Luck RP. A comparison of cosmetic outcomes of lacerations on the extremities and trunk using absorbable versus nonabsorbable sutures. Acad Emerg Med. 2014 Jun;21(6):637-43. doi: 10.1111/acem.12387.

  PMID: 25039547 BACKGROUND

• Quinn JV, Drzewiecki AE, Stiell IG, Elmslie TJ. Appearance scales to measure cosmetic outcomes of healed lacerations. Am J Emerg Med. 1995 Mar;13(2):229-31. doi: 10.1016/0735-6757(95)90100-0.

  PMID: 7893315 BACKGROUND

• Quinn JV, Wells GA. An assessment of clinical wound evaluation scales. Acad Emerg Med. 1998 Jun;5(6):583-6. doi: 10.1111/j.1553-2712.1998.tb02465.x.

  PMID: 9660284 BACKGROUND

• Singer AJ. Clinical wound evaluation scales. Acad Emerg Med. 1998 Jun;5(6):564-6. doi: 10.1111/j.1553-2712.1998.tb02461.x. No abstract available.

  PMID: 9660280 BACKGROUND

Study Officials

• Brian Chinnock, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Chinnock, MD

CONTACT

559-499-6440; bchinnock@fresno.ucsf.edu

Jannet Castaneda, BA

CONTACT

559-994-5893; jcastaneda@fresno.ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 12, 2019
• First Posted: August 14, 2019
• Study Start: September 26, 2019
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)