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Suture Material
Suture Materials for Hand Cuts
N/A
Waitlist Available
Led By Kenneth Taylor, MD
Research Sponsored by Kenneth Taylor, M.D.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Gender: male or female (non-pregnant)
Subject seen in PSHMC Emergency Department for hand or forearm lacerations that require suture repair, in which Hand Surgery is consulted
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial will compare the outcomes of using two different types of stitches in patients with hand lacerations from trauma.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the suture material used (if known allergies exist), infection at the wound site due to improper healing or care post-surgery, discomfort during removal of non-absorbable sutures if applicable.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not pregnant and identify as male or female.
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I was treated for a hand or forearm cut that needed stitches in the ER, and a hand surgeon was consulted.
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I am older than 18 years.
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My surgical wound is classified between grades I to IV.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in wound healing using the Patient and Observer Scar Assessment Scale (POSAS)
Secondary outcome measures
Patient reported pain using the Visual Analog Scale (VAS)
Trial Design
2Treatment groups
Active Control
Group I: Absorbable Surgical Gut SutureActive Control1 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 SutureActive Control1 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.
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Who is running the clinical trial?
Kenneth Taylor, M.D.Lead Sponsor
2 Previous Clinical Trials
58 Total Patients Enrolled
Kenneth Taylor, MDPrincipal InvestigatorPenn State Health Milton S Hershey Medical Center
2 Previous Clinical Trials
58 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am under 18 years old.I am not pregnant and identify as male or female.I was treated for a hand or forearm cut that needed stitches in the ER, and a hand surgeon was consulted.I understand the study and agree to follow all its procedures and visits.I am older than 18 years.I have diabetes.My surgical wound is classified between grades I to IV.I have been on treatments that weaken my immune system.I have difficulty with memory or thinking clearly.I need surgery for an injury to my tendon, nerve, or bone.I do not speak English.
Research Study Groups:
This trial has the following groups:- Group 1: Absorbable Surgical Gut Suture
- Group 2: Non-absorbable Nylon Suture
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies available for participants in this clinical trial?
"The medical trial listed on clinicaltrials.gov is no longer actively recruiting patients, its last update having been September 8th 2022. However, 15 other trials are still in the process of enrolling suitable candidates at this point in time."
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Recent research and studies
Journal of Hand SurgeryJournal
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