Review of Efficacy of Used ultraSonic Energy Device

NCT04226482 | Completed FDA Device

• 1 other identifier: REUSED2019
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Appendectomy; Laparoscopic Surgery; Equipment Reuse; Patient Safety

Outcome Measures

Primary Outcomes (2)

• Lateral Thermal Damage of Mesoappendix

  Microscopically measured distance of lateral thermal damage of mesoappendix

  Through study completion, an average of 1 year.

• Lateral Thermal Damage of Appendiceal Base

  Microscopically measured distance of lateral thermal damage of appendiceal base

  Through study completion, an average of 1 year.

Secondary Outcomes (4)

• Clinical outcome - Postoperative complications

  Postoperative 30 days follow-up

• Clinical outcome - Length of stay

  Through study completion, an average of 1 year.

• Time to transect appendiceal base

  During the surgery

• Rating Device Functionality

  Immediately after surgery

Study Arms (2)

New Device

ACTIVE COMPARATOR

Laparoscopic appendectomy will be done using new ultrasonic shears.

Device: New Device

Used Device

EXPERIMENTAL

Laparoscopic appendectomy will be done using reprocessed ultrasonic shears.

Device: Used Device

Interventions

New Device DEVICE

Laparoscopic appendectomy using new ultrasonic shears.

New Device

Used Device DEVICE

Laparoscopic appendectomy using reprocessed ultrasonic shears.

Used Device

Eligibility Criteria

• Age: 5 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of acute appendicitis confirmed during surgery
• Laparoscopic appendectomy
• Operated with UltraCision harmonic scalpel.

You may not qualify if:

• Finding of innocent (white) appendix
• Pregnancy
• Significant co-morbidity (ASA III-IV)
• Open appendectomy
• Laparoscopic appendectomy using instruments other than Ultracision harmonic scalpel.

Sponsors & Collaborators

• University of Split, School of Medicine: lead
• University Hospital of Split: collaborator
• General Hospital Zadar: collaborator

Study Sites (2)

Clinical Hospital Split

Split, 23000, Croatia

Location

General Hospital Zadar

Zadar, 23000, Croatia

Location

Related Publications (41)

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  PMID: 33241426 DERIVED

Related Links

• The Reprocessing and Reuse of Single-Use Medical Devices in Newfoundland \& Labrador (2010)
• Safety and performance evaluation of remanufactured harmonic scalpels (2010)
• Croatian Law on Medical Products 2017/745 (2018) - Article in Croatian

MeSH Terms

Conditions

Appendicitis

Interventions

Device Approval

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Evaluation Studies as Topic; Investigative Techniques; Consumer Product Safety; Public Health; Environment and Public Health

Study Officials

• Jakov Mihanovic, MD

  General Hospital Zadar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to allocation and instrument used for surgery, with the same clinical treatment and postoperative follow-up.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jakov Mihanovic, Principal Investigator

Model Details: Participants will be randomized to laparoscopic appendectomy with new ultrasonic shears versus laparoscopic appendectomy with reused ultrasonic shears. Randomization sequence will be issued by independent statistician and the participants will be blinded to the surgical instrument used for laparoscopic appendectomy.

Study Record Dates

• First Submitted: December 28, 2019
• First Posted: January 13, 2020
• Study Start: May 27, 2019
• Primary Completion: April 13, 2020
• Study Completion: May 14, 2020
• Last Updated: May 18, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

CR (2)