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Surgical Material
Metal skin staples for Foot and Ankle Injuries
N/A
Waitlist Available
Led By Ashish Shah, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at time of device removal (10-14 days post-op), at 6 weeks, 3 months, and 1 year post-op
Awards & highlights
Study Summary
This trial will compare the outcomes of using staples or sutures for closure in uncomplicated foot and ankle surgeries.
Eligible Conditions
- Foot and Ankle Injuries
- Incision
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at time of device removal (10-14 days post-op), at 6 weeks, 3 months, and 1 year post-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at time of device removal (10-14 days post-op), at 6 weeks, 3 months, and 1 year post-op
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain on removal
Secondary outcome measures
Scar formation
Time to place and remove
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: StaplesExperimental Treatment1 Intervention
For short single incisions, these patients will receive superficial closure using only metal skin staples. Closure will be performed by resident or fellow involved in the case.
Group II: Half Staple Half SutureExperimental Treatment2 Interventions
Some patients will receive both nylon sutures and metal skin staples for superficial closure. If multiple incisions are involved, each incision will count as 1 in the alternation method (i.e. toe 1 will be all sutures, then toe 2 will be all staples). For long incisions, closure will alternate between nylon sutures and metal skin staples on the part of the incision which is closer (more proximal) or farther away (more distal) from the rest of the body.
Group III: SutureActive Control1 Intervention
For short single incisions, these patients will receive superficial closure using only nylon sutures. No metal skin staples will be used. Closure will be performed by resident or fellow involved in the case.
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,583 Previous Clinical Trials
2,280,044 Total Patients Enrolled
Ashish Shah, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of forming abnormal or keloid scars.
Research Study Groups:
This trial has the following groups:- Group 1: Half Staple Half Suture
- Group 2: Suture
- Group 3: Staples
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.
Is registration for this clinical trial currently available?
"The clinicaltrials.gov database discloses that this particular medical trial is no longer recruiting patients, having been last modified on November 3rd of 2022 and first posted on September 1st 2018. However, there are 33 other trials actively enrolling individuals at the present time."
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