MedTrace Logo

Review of Efficacy of Used ultraSonic Energy Device

NCT04226482 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-05-18

No results posted yet for this study

Summary

Single-use medical instruments are intended by the manufacturers for single-use only or for single-patient-use only. Nevertheless, single-use instruments are being reused more than once in many countries around the world. The reasons are mainly economic in developing countries and environmental in developed countries. Concerns are being raised regarding reused instruments sterility and efficacy. Since there is paucity of evidence on safety of multiple use of single-use instruments in surgery, we decided to conduct a clinical study comparing the same surgical procedure performed with new versus reused surgical instrument. We decided to study laparoscopic appendectomy which is a simple and the most common emergency surgery. Instrument under the scrutiny is ultrasonic scalpel which uses high-frequency ultrasound vibration for coagulating and cutting tissue. In the studied period of time, all eligible patients with acute appendicitis will be randomized in two groups, first having surgery with new device and the second having surgery with reused device. Removed appendix will be analyzed for lateral thermal damage and the patients will be followed-up for one month for potential differences in clinical outcomes like pain-killers consumption, length of stay and postoperative complications.

Conditions

  • Appendicitis Acute
  • Safety Issues
  • Complication of Surgical Procedure
  • Device Induced Injury

Interventions

DEVICE

New Device

Laparoscopic appendectomy using new ultrasonic shears.

DEVICE

Used Device

Laparoscopic appendectomy using reprocessed ultrasonic shears.

Sponsors & Collaborators

  • University Hospital of Split

    collaborator OTHER

  • General Hospital Zadar

    collaborator OTHER

  • University of Split, School of Medicine

    lead OTHER

Principal Investigators

  • Jakov Mihanovic, MD · General Hospital Zadar

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-27
Primary Completion
2020-04-13
Completion
2020-05-14
FDA Device
Yes

Countries

  • Croatia

Study Locations

More Related Trials

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 NCT04226482 on ClinicalTrials.gov