Suture Repair of Lacerations in the ED: Comparison Between Two Suture Materials (NCT05281666) | Clinical Trial Compass
TerminatedNot Applicable
Suture Repair of Lacerations in the ED: Comparison Between Two Suture Materials
Stopped: Study closed due to recruitment problems
United States6 participantsStarted 2022-08-23
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subject seen in PSHMC Emergency Department for hand or forearm lacerations (i.e. laceration below the level of the elbow) that require suture repair, in which Hand Surgery is consulted
* CDC surgical wound classification grades I-IV
* Age \>18 years of age
* Gender: male or female (non-pregnant)
* Fluent in written and spoken English
* Subject is able to provide voluntary, written informed consent
* Subject, in the opinion of the clinical investigator, is able to understand the clinical investigation and is willing to perform all study procedures and follow-up visits
* Non-Prisoners
Exclusion Criteria:
* Known allergy to suture material
* History of immunosuppression (i.e. concurrent chemotherapy, steroid use or immunomodulatory therapy)
* History of diabetes mellitus
* Pregnancy
* Current Tobacco use
* Age \< 18 years old
* Previous skin laceration at same location
* History of previous hypertrophic or keloid scar
* Concurrent tendon, nerve or bone injury requiring trip to the operating room
* Non-English speaking patients
* Cognitive impairment
* Prisoners
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Score in Wound Healing From Surgery to 2 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Patient Portion
Timeframe: 2 weeks post-laceration repair
2
Score in Wound Healing From Surgery 6 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Patient Portion
Timeframe: 6 weeks post-laceration repair
3
Score in Wound Healing From Surgery 12 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Patient Portion
Timeframe: 12 weeks post-laceration repair
4
Score in Wound Healing From Surgery to 2 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Observer Portion
Timeframe: 2 weeks post-laceration repair
5
Score in Wound Healing From Surgery 6 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Observer Portion
Timeframe: 6 weeks post-laceration repair
6
Score in Wound Healing From Surgery 12 Weeks Follow-up as Measured Using the Patient and Observer Scar Assessment Scale (POSAS)-Observer Portion