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

6 Participants Needed

Trial Summary

What is the purpose of this trial?

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 wound healing, patient perception, and development of complications.

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 data supports the effectiveness of the treatment using absorbable and non-absorbable suture materials for hand cuts?

Research shows that absorbable sutures like polyglycolic acid are effective in various surgeries, offering advantages over traditional materials by reducing complications. Non-absorbable sutures maintain their strength, making them reliable for wound support. ^{1 2 3 4 5}

Is it safe to use suture materials in humans?

There is a case report of cancer developing at the site of non-absorbable suture material, which suggests that there may be some risks associated with its use. ^{6 7 8 9 10}

How do absorbable and non-absorbable sutures differ in treating hand cuts?

Absorbable sutures, like surgical gut sutures, dissolve over time and don't need to be removed, while non-absorbable sutures, such as nylon, remain in the body until they are manually removed. This makes absorbable sutures convenient for patients who prefer not to return for suture removal. ^{3 5 11 12 13}

Research Team

Kenneth Taylor, MD

Principal Investigator

Penn State Health Milton S Hershey Medical Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Assessment of suture materials for intestinal use by an extramucosal implant technique and a quantitative histological evaluation. [2019]

2. United States 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. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Wound closure sutures and needles: a new perspective. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Experience with the use of polyglycolic acid suture material (Dexon) in 500 surgical patients. [2004]

5. Ukraine pubmed.ncbi.nlm.nih.gov

[The role of antibacterial dissolving suture materials in the prevention of post-resection syndromes]. [2016]

6. England pubmed.ncbi.nlm.nih.gov

Oesophageal "cross"--a sinister foreign body. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Ingestion of a denture cleanser: did it cause gastric perforation? [2022]

8. England pubmed.ncbi.nlm.nih.gov

Jejunal carcinoma associated with non-absorbable suture material. [2019]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Peritonitis with small intestinal perforation caused by a plastic bread bag clip: A case report. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Endoscopic management of magnet ingestion and its adverse events in children. [2022]

11. Italy pubmed.ncbi.nlm.nih.gov

[Monofilaments in digestive system surgery]. [2007]

12. United States pubmed.ncbi.nlm.nih.gov

The effect of a hydrogen peroxide wound care regimen on tensile strength of suture. [2013]

13. United States pubmed.ncbi.nlm.nih.gov

Synthetic absorable sutures. [2012]