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Staple Versus Suture Closure for Foot and Ankle Surgery

NCT03522753 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2023-09-18

No results posted yet for this study

Summary

This study aims to determine if staples or sutures are better for the closure of uncomplicated foot and ankle surgeries. Currently, most surgeons base their choice for closure on previous teaching from a mentor during fellowship or personal experience. There is no standard of care for closure material on hand surgeries to date. This study will prospectively randomize patients to have either staple or suture wound closure if they have a short incision. In surgeries with longer incisions (i.e. 5+ cm), or multiple incisions on similar sites (i.e. bilateral operations, multiple toes), patients will have half sutures and half staple closure. The three primary measured outcomes will be: pain upon suture/staple removal, time to place and remove sutures vs. staples, and scar formation.

Conditions

  • Incision
  • Foot Ankle Injuries

Interventions

DEVICE

Metal skin staples

Routine closure methods/material for surgical wounds

DEVICE

Nylon sutures

Routine closure methods/material for surgical wounds

Sponsors & Collaborators

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Ashish Shah, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2022-10-01
Completion
2023-09-15
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03522753 on ClinicalTrials.gov