NCT04226482: REUSED

Review of Efficacy of Used ultraSonic Energy Device

Completed NA Last updated 18 May 2020

What this trial tests

NA trial testing New Device in Appendicitis Acute in 100 participants. Completed in 14 May 2020.

Timeline

27 May 2019

Primary endpoint
13 April 2020

14 May 2020

Quick facts

Lead sponsor	University of Split, School of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	100
Start date	27 May 2019
Primary completion	13 April 2020
Estimated completion	14 May 2020
Sites	2 locations across Croatia

Drugs / interventions tested

• New Device
• Used Device

Conditions studied

• Appendicitis Acute — all drugs for Appendicitis Acute →
• Safety Issues — all drugs for Safety Issues →
• Complication of Surgical Procedure — all drugs for Complication of Surgical Procedure →
• Device Induced Injury — all drugs for Device Induced Injury →

Sponsor

University of Split, School of Medicine

Who can join

Adults 5 to 65, any sex, with Appendicitis Acute or Safety Issues. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Comparison of new versus reused Harmonic scalpel performance in laparoscopic appendectomy in patients with acute appendicitis-a randomized clinical trial.
   Mihanović J, Šikić NL, Mrklić I, Katušić Z, et al · · 2021 · cited 16× · PMID 33241426 · DOI 10.1007/s00423-020-02039-y