Absorbable vs Nonabsorbable Sutures for Cuts

Recruiting at 1 trial location

Overseen By Jannet Castaneda, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: High infection potential, keloid formers, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: Immediate

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if absorbable sutures, which dissolve on their own, are as effective for healing cuts on the trunk or arms and legs as traditional nonabsorbable sutures that require removal. The focus is on the appearance of the skin three months after stitching. Individuals with a single cut longer than 2 cm on their trunk or extremities, requiring simple stitches, may be suitable for this study. The absorbable sutures being tested include Vicryl Rapide (also known as Coated VICRYL RAPIDE or Polyglactin 910). As an unphased trial, this study provides an opportunity to contribute to medical knowledge and potentially benefit from innovative suture technology.

Will I have to stop taking my current medications?

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

What prior data suggests that these sutures are safe for wound repair?

Research shows that Vicryl Rapide is generally safe for treating minor skin wounds, such as cuts. This type of stitch dissolves on its own over time. Studies indicate it supports wounds for about 7 to 10 days.

Previous research on similar stitches suggests safety. Patients using stitches like Vicryl Rapide have not reported major negative side effects. These stitches are usually well-tolerated by patients.

In summary, Vicryl Rapide is considered safe for treating surface-level skin wounds, with minimal risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about testing absorbable sutures like Vicryl Rapide for wound repair because they offer potential advantages over traditional nonabsorbable sutures. Unlike nonabsorbable sutures, which require removal and can cause discomfort, absorbable sutures naturally dissolve in the body, eliminating the need for a follow-up procedure. This means less hassle for patients and potentially lower risk of infection. Additionally, Vicryl Rapide is designed to break down more quickly than other absorbable sutures, making it particularly useful for superficial wounds that heal faster.

What evidence suggests that this trial's treatments could be effective for traumatic laceration repair?

Research has shown that Vicryl Rapide, a self-dissolving stitch, effectively aids wound healing. In one study, nearly all wounds healed well within two weeks, with only minor issues unrelated to the stitches. Patients using Vicryl Rapide reported less pain after some surgeries compared to those with other stitches. Another study found that patients were as satisfied with Vicryl Rapide as with regular Vicryl stitches, indicating the dissolvable option works equally well. This trial will compare the effectiveness of Vicryl Rapide, used in the absorbable suture arm, with traditional nonabsorbable sutures in the nonabsorbable arm. Overall, these findings suggest that Vicryl Rapide is a reliable choice for closing wounds, with results similar to traditional non-dissolving stitches. ^{6 7 8 9 10}

Who Is on the Research Team?

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.

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?

Group I: Absorbable Active Control 1 Intervention

Wound repaired with Vicryl Rapide absorbable suture

Group II: Nonabsorbable Active Control 1 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

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 study involving 98 rat colonic anastomoses, there was no significant difference in complication rates or tissue reaction between the traditional polyglactin 910 (Vicryl) and the newer monofilament absorbable suture, polydioxanone (PDS).

The findings suggest that using a monofilament suture with a longer dissolution time does not provide additional safety or security for colonic anastomoses compared to Vicryl.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative study of polydioxanone (PDS) and polyglactin 910 (Vicryl) in colonic anastomoses in rats. Andersen, E., Søndenaa, K., Holter, J.[2019]

In a study of 40 procedures involving 32 patients, both 7/0 Vicryl and 7/0 Vicryl rapide sutures demonstrated excellent wound healing, with only one case of slight wound gape not linked to the sutures.

No significant inflammatory reactions were observed, and only one out of 144 sutures required removal, indicating that these sutures are both safe and effective for skin closure in ophthalmic plastic surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of 7/0 Vicryl (coated polyglactin 910) and 7/0 Vicryl-rapide (irradiated polyglactin 910) in skin closure in ophthalmic plastic surgery. Talbot, AW., Meadows, AE., Tyers, AG., et al.[2019]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vicryl sutures. Aston, SJ., Rees, TD.[2021]

In a study involving 35 patients undergoing corneal surgery, the use of 9-0 or 10-0 absorbable Vicryl sutures effectively maintained wound closure with minimal tissue reaction.

The absorbable sutures were completely absorbed within six weeks, making them a practical option for patients, as they eliminate the need for a second procedure to remove sutures, which can be particularly beneficial for small corneal lacerations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical evaluation of 9-0 and 10-0 monofilament Polyglactin 910 absorbable suture for corneal surgery. Cowden, JW.[2014]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vicryl Rapide versus Vicryl suture in skin closure of the hand in children: a randomized prospective study. Al-Qattan, MM.[2012]

In a study involving 20 New Zealand rabbits, Velosorb™ Fast sutures demonstrated comparable efficacy to Vicryl™ Rapide sutures for skin and vaginal incisions, with no significant differences in healing outcomes based on histological analysis.

All rabbits survived the procedure, indicating that both sutures are safe for use in surgical applications, and the study had a power of ≥80%, ensuring reliable results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of in vivo properties of Velosorb™ fast versus Vicryl™ rapide in a functional rabbit model of intradermic suture and episiotomy. Vieille, P., Huberlant, S., Bastide, S., et al.[2019]

The absorbable suture Polyglactin 910 (Vicryl) demonstrated equal mechanical properties compared to the non-absorbable suture (Ethilon) in microsurgical procedures involving nerves and vessels, indicating its efficacy for surgical use.

By the 10th week post-surgery, the tissue reaction to the absorbable suture had resolved, which is a safety advantage, although its poor visibility under the microscope was noted as a drawback.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Microsurgical nerve and blood vessel sutures with resorbable suture material]. Duspiva, W., Ippisch, A., Wriedt-Lübbe, I., et al.[2006]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Absorbable versus non-absorbable suture in carpal tunnel decompression. Erel, E., Pleasance, PI., Ahmed, O., et al.[2009]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/10412244/

Outcomes of irradiated polyglactin 910 Vicryl Rapide fast ... Results: In the group with intraoral wounds, there were two cases of suppuration with no inflammatory reactions or hypertrophic scarring when IRPG sutures were ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0301211525003628

Outcomes of suture material, suture technique and tissue ... Data from a single study comparing Vicryl vs Vicryl Rapide showed there was no significant difference in patient satisfaction with the repair between the groups ...

3. journals.lww.com journals.lww.com/jsci/fulltext/2013/40020/comparison_of_impact_of_polyglactin_910__vicryl.8.aspx

Comparison of impact of polyglactin 910 (Vicryl rapide) and ... Compared to CC, VR produced significantly less pain (P < 0.001) among patients following episiotomy wound repair in walking, sitting, and lying posture.

4. tandfonline.com tandfonline.com/doi/abs/10.1076/orbi.21.1.1.2604

Use of 7/0 Vicryl (coated polyglactin 910) and 7/ ... RESULTS : Wound healing was excellent at 2 weeks in all but one Vicryl rapide patient whose slight wound gape was not attributable to the suture material used.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10300501/

Clinical equivalence of Trusynth fast ® and Vicryl rapide ... A non-significant, but faster wound healing was noted in Trusynth Fast ® group as compared to Vicryl Rapide ® group.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/16201941/

Controlled Clinical Trial Comparing Coated VICRYL Plus ... Coated polyglactin 910 suture with triclosan performed as well or better than traditional coated polyglactin 910 suture in pediatric patients undergoing ...

7. jnjmedtech.com jnjmedtech.com/en-US/product/vicryl-rapide-polyglactin-910-suture

VICRYL RAPIDE™ Suture (polyglactin 910) - J&J MedTech VICRYL RAPIDE Suture is the fastest-absorbing Ethicon synthetic suture and is indicated for use in superficial soft tissue approximation of the skin and mucosa.

8. ethicon.com ethicon.com/na/epc/code/vr490

VR490 - Ethicon Surgical Technologies VICRYL RAPIDE is an absorbable suture material, the use of supplemental nonabsorbable sutures should be considered by the surgeon in the closure of sites.

9. scottsdental.com scottsdental.com/vicryl-rapide-sutures.html?srsltid=AfmBOoqk_Io-4bomyakSzm-FLfXcY2lo0K-Bh-jKKbxWPRio5avzXYnO

VICRYL RAPIDE Sutures It is indicated only for use in superficial soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required.

10. pattersondental.com pattersondental.com/Supplies/scalpel-suture/absorbable-suture-needle-combination/coated-vicryl-rapide-sutures-absorbable/PIF_107026

Coated VICRYL™ RAPIDE Sutures Absorbable It is indicated only for use in superficial soft tissue approximation of the skin and mucosa, where only short term wound support (7-10 days) is required.