Suture Materials for Hand Cuts

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kenneth Taylor, M.D.

Must not be taking: Chemotherapy, Steroids, Immunomodulators

Disqualifiers: Diabetes, Pregnancy, Tobacco use, others

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

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether nylon or absorbable stitches work best for healing cuts on the hand. Researchers aim to assess how each type affects wound healing, patient satisfaction, and potential complications. Individuals with recent hand or forearm cuts requiring stitches, treated at the PSHMC Emergency Department, may qualify. As an unphased trial, this study provides a unique opportunity to contribute to understanding the best stitching methods for hand injuries.

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 suture materials are safe for hand cuts?

Research shows that both absorbable and non-absorbable sutures are generally safe for closing cuts on the hand.

Absorbable sutures, which dissolve on their own, offer a good option for stitching hand cuts. One study found that patients with absorbable sutures experienced similar outcomes to those with non-absorbable sutures, including low infection rates. This suggests that absorbable sutures are safe and well-tolerated.

Non-absorbable nylon sutures, which require removal later, are also widely used and considered safe. Research comparing these with absorbable sutures found similar results in terms of pain, scar appearance, and infection rates. This indicates that nylon sutures are well-tolerated by most patients.

In summary, both types of sutures are safe and have few reported issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these suture materials for hand cuts because each has distinct advantages. The absorbable surgical gut suture is derived from natural sources like bovine or sheep intestines and is absorbed by the body over time, eliminating the need for removal and reducing follow-up visits. This is particularly beneficial for patients who want a more convenient recovery process. On the other hand, the non-absorbable nylon suture is made from strong synthetic polymers, providing long-lasting support for wound healing, which is crucial in complex repairs or for patients needing extra strength in sutures. Both options offer unique benefits compared to traditional sutures, allowing for more tailored treatment depending on patient needs and wound complexity.

What evidence suggests that this trial's treatments could be effective for hand cuts?

This trial will compare two types of stitches for hand cuts: absorbable surgical gut suture and non-absorbable nylon suture. Studies have shown that both types effectively close hand cuts. Research suggests that absorbable stitches, like chromic gut, can serve as a good alternative to non-absorbable ones, such as nylon, for hand surgeries. Participants receiving absorbable stitches have shown similar healing and wound appearance. Non-absorbable nylon stitches are often used for their strength and visibility. Overall, both types are reliable for treating hand cuts, with no major differences in scar appearance or hand function reported in some studies. ^{2 4 6 7 8}

Who Is on the Research Team?

Kenneth Taylor, MD

Principal Investigator

Penn State Health Milton S Hershey Medical Center

Are You a Good Fit for This Trial?

Adults over 18 with hand or forearm lacerations suitable for suture repair in the emergency department can join this trial. They must speak and understand English, be able to consent, follow study procedures, and not be pregnant or imprisoned. Excluded are those with diabetes, tobacco use, cognitive impairments, immunosuppression, previous scars or injuries at the same site.

Inclusion Criteria

I am not pregnant and identify as male or female.

Fluent in written and spoken English

I was treated for a hand or forearm cut that needed stitches in the ER, and a hand surgeon was consulted.

Exclusion Criteria

I am under 18 years old.

Known allergy to suture material

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive suture repair of hand lacerations using either absorbable or non-absorbable sutures

1 day

1 visit (in-person)

Follow-up

Participants are monitored for wound healing and pain at 2, 6, and 12 weeks after treatment

12 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Absorbable Surgical Gut Suture material
• Non-absorbable Nylon Suture Material

Trial Overview The trial is testing two types of sutures for repairing cuts on hands and forearms: absorbable surgical gut sutures versus non-absorbable nylon sutures. It will assess healing quality, patient satisfaction, and any complications arising from the different suture materials.

How Is the Trial Designed?

Group I: Absorbable Surgical Gut Suture Active Control 1 Intervention

Ethicon Chromic Surgical Gut Suture Is an absorbable, sterile surgical suture composed of purified connective tissue (mostly collagen) derived from either the serosal layer of beef (bovine) or the submucosal fibrous layer of sheep (ovine) Intestines. Surgical Gut Suture is Indicated for use In general soft tissue approximation and/or ligation, including use In ophthalmic procedures, but not for use in cardiovascular and neurologic tissues.

Group II: Non-absorbable Nylon Suture Active Control 1 Intervention

Ethicon ETHILON\* nylon suture is a nonabsorbab\\e, sterile surgical monofi\\ament suture composed of the long-chain aliphatic polymers Nylon 6 and Nylon 6,6. ETHILON sutures are dyed black or green to enhance visibility in tissue. The suture is also available undyed (clear). ETHILON suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Who Is Running the Clinical Trial?

Kenneth Taylor, M.D.

Lead Sponsor

Trials

3

Recruited

90+

Published Research Related to This Trial

In a study comparing 6-0 and 5-0 Fast Absorbing Gut sutures for linear cutaneous surgery on the head and neck, no significant difference in scar appearance was found, indicating that both suture sizes yield similar cosmetic outcomes.

The study also showed no significant difference in complication rates between the two suture sizes, suggesting that both are equally safe for use in this type of surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of 5-0 Fast Absorbing Gut versus 6-0 Fast Absorbing Gut during cutaneous wound closure on the head and neck: A randomized evaluator-blinded split-wound comparative effectiveness trial. Pourang, A., Crispin, MK., Clark, AK., et al.[2019]

Endoscopic removal of ingested magnets in children is a feasible and safe procedure, with no major adverse events reported during the process, based on a case series of 3 patients.

Prolonged retention of ingested magnets can lead to serious complications, such as magnet-related fistulas, highlighting the need for increased awareness among the public and healthcare professionals regarding the risks associated with magnet ingestion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic management of magnet ingestion and its adverse events in children. Chavan, R., Bachkaniwala, V., Tadkalkar, V., et al.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0736467997001479

Emergency department repair of hand lacerations using ... The use of absorbable suture material has a number of potential advantages when compared to nonabsorbable suture. We conducted a 5-year retrospective study ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34509310/

Randomized Controlled Trial Comparing Nylon and ... Our findings suggests that Chromic sutures are a viable alternative to polyamide sutures after office hand surgery.

3. withpower.com withpower.com/trial/phase-lacerations-4-2022-6b880

Suture Materials for Hand Cuts · Info for Participants This study aims to determine whether the use of non-absorbable (i.e. nylon) versus absorbable (i.e. chromic gut) sutures in traumatic hand lacerations affects ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7192227/

A Randomized Evaluator Blind Split Wound Trial 5-0 polypropylene resulted in small but statistically significant better cosmetic outcomes than 5-0 fast absorbing plain gut.

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf2/k021043.pdf

Summary of Safety & Effectiveness Absorbable Surgical Gut ... “Grams Absorbable Surgical Gut Suture (Plain and Chromic) is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic.

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06247761

NCT06247761 | STASSH - TRAUMA - Absorbable vs Non- ... Emergency hand surgery patients - randomized to either absorbable or non-absorbable suture. The primary outcomes investigated will be: • Infection occurrence.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10452930/

Absorbable Sutures and Telemedicine for Patients ... The results of this study demonstrate that the use of an absorbable suture and telemedicine protocol for patients undergoing trigger finger ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/9348057/

Emergency department repair of hand lacerations using ... We conclude that the use of absorbable suture material is an acceptable alternative in the repair of hand lacerations.