96 Participants Needed

Absorbable vs Nonabsorbable Sutures for Cuts

Recruiting at 1 trial location
BC
JC
Overseen ByJannet Castaneda, BA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is it safe to use absorbable sutures like Vicryl Rapide in humans?

Vicryl Rapide (Polyglactin 910) is generally considered safe for use in humans, with studies showing it maintains wound closure effectively and causes little tissue reaction. It is used in various surgeries, including skin and corneal surgeries, and is absorbed by the body within weeks, reducing the need for suture removal.12345

How does the treatment Vicryl Rapide differ from other treatments for cuts?

Vicryl Rapide is unique because it is an absorbable suture that dissolves quickly, reducing the risk of prolonged presence in the body and potential complications, making it particularly suitable for pediatric surgeries compared to traditional non-absorbable sutures.23467

What data supports the effectiveness of the treatment Vicryl Rapide, Coated VICRYL RAPIDE, Polyglactin 910 for cuts?

Research shows that Vicryl Rapide sutures are effective for skin closure, especially in children, as they absorb quickly and reduce complications compared to regular Vicryl sutures. Additionally, they maintain adequate wound closure with minimal tissue reaction, making them suitable for various surgical applications.24568

Who Is on the Research Team?

BC

Brian Chinnock, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

Adults over 18 with a single laceration longer than 2 cm on the trunk or extremity that can be closed with simple stitches. Excluded are those with wound healing issues, mental incapacity to consent, non-English/Spanish speakers, no reliable contact info, multiple lacerations needing sutures in the same area, and wounds at high risk of infection or poor healing.

Inclusion Criteria

You have a cut that is longer than 2 centimeters.
I have a single cut on my body or limb that needs stitches.
My wound will be closed with basic stitching.

Exclusion Criteria

My wound is longer than 10 cm and involves tendon or cartilage.
It is unlikely that the treatment will result in a good appearance or cosmetic outcome.
I have a wound that is not healing properly or has reopened.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Suture closure with either Vicryl Rapide or nonabsorbable suture according to randomization

Immediate
1 visit (in-person)

Follow-up

Participants receive a follow-up call to assess complications and chart review for any ED revisits

4 weeks
1 call (virtual)

Three-month Follow-up

Participants have a follow-up visit for wound photography and cosmesis evaluation

3 months
1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Vicryl Rapide
Trial Overview The trial is testing if Vicryl Rapide (an absorbable suture) is as good for stitching up skin cuts on body/extremities as nonabsorbable sutures. It's a controlled study where patients are randomly chosen to get one type of stitch and then checked after three months.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: AbsorbableActive Control1 Intervention
Wound repaired with Vicryl Rapide absorbable suture
Group II: NonabsorbableActive Control1 Intervention
Wound repaired with traditional nonabsorbable suture

Vicryl Rapide is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Vicryl Rapide for:
  • Superficial soft tissue approximation of the skin and mucosa where only short-term wound support (7-10 days) is required
🇪🇺
Approved in European Union as Vicryl Rapide for:
  • Skin closure, cuticular or subcuticular
  • Episiotomies
  • Closure of oral mucosa
  • Conjunctival sutures in ophthalmic surgery

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Central California Faculty Medical Group

Collaborator

Trials
3
Recruited
640+

Published Research Related to This Trial

In a randomized clinical study comparing absorbable sutures (polyglactin 910) and non-absorbable sutures (monofilament polypropylene) for carpal tunnel surgery, patients reported more pain with the non-absorbable sutures.
At the 6-week follow-up, the absorbable suture group showed higher levels of residual wound inflammation, suggesting that while they may cause less immediate pain, they could lead to more prolonged inflammation.
Absorbable versus non-absorbable suture in carpal tunnel decompression.Erel, E., Pleasance, PI., Ahmed, O., et al.[2009]
Polyglactin 910 (Vicryl) is an absorbable suture material that meets many desired qualities for surgical use, making it a valuable tool for surgeons.
The review includes laboratory investigations and clinical studies that support the efficacy and safety of Vicryl, highlighting its positive impact based on the authors' experiences.
Vicryl sutures.Aston, SJ., Rees, TD.[2021]
In a study involving 60 children undergoing elective hand surgery, Vicryl Rapide sutures resulted in no wound complications, while Vicryl sutures led to five complications due to their delayed absorption.
The findings suggest that Vicryl Rapide sutures are safer and more effective for pediatric hand surgery, as they reduce the risk of complications associated with prolonged suture presence.
Vicryl Rapide versus Vicryl suture in skin closure of the hand in children: a randomized prospective study.Al-Qattan, MM.[2012]

Citations

Absorbable versus non-absorbable suture in carpal tunnel decompression. [2009]
Vicryl sutures. [2021]
Vicryl Rapide versus Vicryl suture in skin closure of the hand in children: a randomized prospective study. [2012]
Evaluation of in vivo properties of Velosorb™ fast versus Vicryl™ rapide in a functional rabbit model of intradermic suture and episiotomy. [2019]
The clinical evaluation of 9-0 and 10-0 monofilament Polyglactin 910 absorbable suture for corneal surgery. [2014]
Use of 7/0 Vicryl (coated polyglactin 910) and 7/0 Vicryl-rapide (irradiated polyglactin 910) in skin closure in ophthalmic plastic surgery. [2019]
A comparative study of polydioxanone (PDS) and polyglactin 910 (Vicryl) in colonic anastomoses in rats. [2019]
[Microsurgical nerve and blood vessel sutures with resorbable suture material]. [2006]
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