Appendicitis AcuteREUSEDNCT04226482
Review of Efficacy of Used ultraSonic Energy Device
A study testing New Device and Used Device in people with Appendicitis Acute and Safety Issues, run by University of Split, School of Medicine at 2 sites in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 65 years
- Conditions the study is for
- Appendicitis Acute, Safety Issues, Complication of Surgical Procedure
- What is being tested?
- New Device and Used Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesCroatia
- Study dates
- 27 May 2019to 14 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of acute appendicitis confirmed during surgery
- Laparoscopic appendectomy
- Operated with UltraCision harmonic scalpel.
Who cannot join
- Finding of innocent (white) appendix
- Pregnancy
- Significant co-morbidity (ASA III-IV)
- Open appendectomy
- Laparoscopic appendectomy using instruments other than Ultracision harmonic scalpel.
Trial locations and contacts
2 sites in 1 country.
Croatia2 sites
Clinical Hospital Split
Split, 23000
General Hospital Zadar
Zadar, 23000
About this study
Official title: Comparison of Lateral Thermal Damage and Clinical Outcomes of Laparoscopic Appendectomy With New Versus Reused Ultrasonic Scalpel in Patients With Acute Appendicitis - Randomized Clinical Trial
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.
Read the detailed description
Laparoscopic appendectomy provides enhanced recovery at increased costs due to a need for a specific sophisticated equipment. Currently many of the commonly used devices are labeled by manufacturers as single-use only. This trend has stronghold in concerns about patient safety, especially about prevention of cross-infections and other safety-related issues. On the other hand, surgery costs are increased exponentially. There is paucity of evidence on safety of reusing single-use devices (SUD) in surgery. Reuse of SUD which may include refurbishing or reprocessing and resterilization is a complex issue with moral, technical, economical and environmental repercussions. There are several papers discussing the ethical dilemmas involved. The reprocessed instruments are generally deemed equally safe as new one. However there are only few experimental and clinical studies on this topic. Most of them are influenced by sponsors or manufacturers and therefore biased. What's more their conclusions are sometimes highly controversial. Goal of this study is to provide solid evidence on safety of reuse of SUD and to discover differences in in-vitro and clinical outcomes. One of the most common SUD for laparoscopic surgery is ultrasonic scalpel which uses high-frequency jaw vibration which simultaneously coagulates and divides structures with minimal thermal damage to surrounding tissue. One of the best known ultrasonic shears intended for single-use is harmonic scalpel (Ultracision® Ethicon EndoSurgery, Johnson\&Johnson Company). Ultrasonic shears are being refurbished and/or resterilized for repetitive use in limited number of cycles or until become dysfunctional or disintegrate. Routine depends on local regulations and variations in practice. To encourage or to ban aforementioned practice we need solid evidence based on properly conducted clinical trial. Therefore we have designed a single-blind randomised clinical trial depending on virginity of instrument used for tissue dissection. Since Ultracision device is the most commonly used ultrasonic sealing device we decided to study outcomes of surgery performed with the new (unused) instrument versus resterilized reused instrument.
All of the patients with clinical and radiological suspicion of having acute appendicitis will be blindly allocated in two arms according to the predefined random sequence provided by independent statistician. Eligible patients will sign an informed consent form. First arm will have laparoscopic appendectomy with new ultrasonic device. The patient will be blinded for the allocation, but the surgeon can not be blinded since packing of the new and reused instruments differ. Even if the scrub nurse would give surgeon instruments without packing, some minor damage might be seen on the plastic coating of the instrument jaws. The second arm will have laparoscopic appendectomy with reused ultrasonic device. All other treatment including surgical technique, postoperative management and follow-up will be unchanged or within the standard of care. Surgical technique is standardised three-trocar approach in general anesthesia. All other details of the surgery are variable depending on local findings, extent of inflammation, anatomy variations etc. Removed specimens will be analyzed routinely with addition of measurement of lateral thermal damage of mesoappendix and appendiceal base. Patients will be screened for antibiotic therapy length, analgesics consumption, early surgical complications according to Clavien-Dindo classification and length of stay. Additionally one month follow-up will be conducted to pick-up possible late complications or readmissions. Study will be conducted in two centers for a period of time until sufficient number of participants are recruited.
- Conditions
- Appendicitis Acute, Safety Issues, Complication of Surgical Procedure, Device Induced Injury
- Being tested
- New Device, Used Device
- Keywords
- Appendectomy, Laparoscopic Surgery, Equipment Reuse, Patient Safety
- Medical subject headings
- Appendicitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New DeviceDevice
Laparoscopic appendectomy using new ultrasonic shears.
Used DeviceDevice
Laparoscopic appendectomy using reprocessed ultrasonic shears.
| Study group | Role | What they receive |
|---|---|---|
| New Device | Active comparator | Laparoscopic appendectomy will be done using new ultrasonic shears. Receives: Device: New Device |
| Used Device | Experimental | Laparoscopic appendectomy will be done using reprocessed ultrasonic shears. Receives: Device: Used Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lateral Thermal Damage of Mesoappendix
Microscopically measured distance of lateral thermal damage of mesoappendix
Measured: Through study completion, an average of 1 year.
Lateral Thermal Damage of Appendiceal Base
Microscopically measured distance of lateral thermal damage of appendiceal base
Measured: Through study completion, an average of 1 year.
Secondary outcomes (4)
Clinical outcome - Postoperative complications
Clavien Dindo classification of postoperative complications
Measured: Postoperative 30 days follow-up
Clinical outcome - Length of stay
In-hospital stay in days
Measured: Through study completion, an average of 1 year.
Time to transect appendiceal base
Speed of transection of appendiceal base regarding its diameter in seconds
Measured: During the surgery
Rating Device Functionality
Rating of Surgeon's satisfaction with ultrasonic shears' performance using Performance Evaluation Scale (PES) where: 1 is unacceptable, 2 is acceptable, 3 is optimal.
PES has 5 categories: 1. Hemostasis, 2. Coagulation effect, 3. Cutting effect, 4. Instrument activation force, 5. Disturbing sounds.
Measured: Immediately after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start27 May 2019
- Primary completion13 Apr 2020
- Study completion14 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Appendicitis AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Split, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Split, General Hospital Zadar
- Responsible party
- Principal investigator, Jakov Mihanovic, University of Split, School of Medicine
- Investigators
- Jakov Mihanovic, MD, Principal investigator, General Hospital Zadar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226482
- Sponsor's protocol ID
- REUSED2019
- Acronym
- REUSED
- Status last verified
- May 2020
- First submitted
- 28 Dec 2019
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Chu T, Chandhoke RA, Smith PC, Schwaitzberg SD. The impact of surgeon choice on the cost of performing laparoscopic appendectomy. Surg Endosc. 2011 Apr;25(4):1187-91. doi: 10.1007/s00464-010-1342-1. Epub 2010 Sep 11.
PubMed 20835717Dunn D. Reprocessing single-use devices--the ethical dilemma. AORN J. 2002 May;75(5):989-99; quiz 1000-4. doi: 10.1016/s0001-2092(06)61462-2.
PubMed 12063946Collier R. The ethics of reusing single-use devices. CMAJ. 2011 Aug 9;183(11):1245. doi: 10.1503/cmaj.109-3907. Epub 2011 Jul 11. No abstract available.
PubMed 21746819Lester BR, Miller K, Boers A, Harris DC, Gamble WG. Comparison of in vivo clinical performance and shaft temperature and in vitro tissue temperature and transection times between new and reprocessed harmonic scalpels. Surg Laparosc Endosc Percutan Tech. 2010 Oct;20(5):e150-9. doi: 10.1097/SLE.0b013e3181eff973.
PubMed 20975490Weld KJ, Dryer S, Hruby G, Ames CD, Venkatesh R, Matthews BD, Landman J. Comparison of mechanical and in vivo performance of new and reprocessed harmonic scalpels. Urology. 2006 May;67(5):898-903. doi: 10.1016/j.urology.2005.11.027.
PubMed 16698349Jacobs P, Akpinar I. Single-use medical devices: economic issues. Heart Asia. 2018 Nov 9;10(2):e011034. doi: 10.1136/heartasia-2018-011034. eCollection 2018. No abstract available.
PubMed 30556542Hailey D, Jacobs PD, Ries NM, Polisena J. Reuse of single use medical devices in Canada: clinical and economic outcomes, legal and ethical issues, and current hospital practice. Int J Technol Assess Health Care. 2008 Fall;24(4):430-6. doi: 10.1017/S0266462308080562.
PubMed 18828937Sloan TW. Safety-cost trade-offs in medical device reuse: a Markov decision process model. Health Care Manag Sci. 2007 Feb;10(1):81-93. doi: 10.1007/s10729-006-9007-2.
PubMed 17323656Collier R. Reprocessing single-use devices: an international perspective. CMAJ. 2011 Aug 9;183(11):1244. doi: 10.1503/cmaj.109-3906. Epub 2011 Jul 4. No abstract available.
PubMed 21727228Popp W, Rasslan O, Unahalekhaka A, Brenner P, Fischnaller E, Fathy M, Goldman C, Gillespie E. What is the use? An international look at reuse of single-use medical devices. Int J Hyg Environ Health. 2010 Jul;213(4):302-7. doi: 10.1016/j.ijheh.2010.04.003. Epub 2010 May 13.
PubMed 20471316Magetsari R, van der Houwen EB, Bakker MT, van der Mei HC, Verkerke GJ, Rakhorst G, Hilmy CR, van Horn JR, Busscher HJ. Biomechanical and surface physico-chemical analyses of used osteosynthesis plates and screws--potential for reuse in developing countries? J Biomed Mater Res B Appl Biomater. 2006 Nov;79(2):236-44. doi: 10.1002/jbm.b.30534.
PubMed 16680715Roth K, Heeg P, Reichl R. Specific hygiene issues relating to reprocessing and reuse of single-use devices for laparoscopic surgery. Surg Endosc. 2002 Jul;16(7):1091-7. doi: 10.1007/s00464-001-9190-7. Epub 2002 Apr 9.
PubMed 12165829Fengler TW, Pahlke H, Bisson S, Kraas E. The clinical suitability of laparoscopic instrumentation. A prospective clinical study of function and hygiene. Surg Endosc. 2000 Apr;14(4):388-94. doi: 10.1007/s004640020064.
PubMed 10790561Manatakis DK, Georgopoulos N. Reducing the Cost of Laparoscopy: Reusable versus Disposable Laparoscopic Instruments. Minim Invasive Surg. 2014;2014:408171. doi: 10.1155/2014/408171. Epub 2014 Jul 22.
PubMed 25152814Druzijanic N, Pogorelic Z, Perko Z, Mrklic I, Tomic S. Comparison of lateral thermal damage of the human peritoneum using monopolar diathermy, Harmonic scalpel and LigaSure. Can J Surg. 2012 Oct;55(5):317-21. doi: 10.1503/cjs.000711.
PubMed 22854112
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lateral Thermal Damage and Clinical Outcomes of Laparoscopic Appendectomy With New Versus Reused Ultrasonic Scalpel in Patients With Acute Appendicitis - Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04226482
- Acronym / sponsor ID
- REUSED / REUSED2019
- Conditions
- Appendicitis Acute, Safety Issues, Complication of Surgical Procedure, Device Induced Injury
- Keywords
- Appendectomy, Laparoscopic Surgery, Equipment Reuse, Patient Safety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Split, School of MedicineUniversity, hospital or other
- Collaborators
- University Hospital of Split, General Hospital Zadar
- Study start
- 27 May 2019 (actual)
- Primary completion
- 13 Apr 2020 (actual)
- Study completion
- 14 May 2020 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Laparoscopic appendectomy provides enhanced recovery at increased costs due to a need for a specific sophisticated equipment. Currently many of the commonly used devices are labeled by manufacturers as single-use only. This trend has stronghold in concerns about patient safety, especially about prevention of cross-infections and other safety-related issues. On the other hand, surgery costs are increased exponentially. There is paucity of evidence on safety of reusing single-use devices (SUD) in surgery. Reuse of SUD which may include refurbishing or reprocessing and resterilization is a complex issue with moral, technical, economical and environmental repercussions. There are several papers discussing the ethical dilemmas involved. The reprocessed instruments are generally deemed equally safe as new one. However there are only few experimental and clinical studies on this topic. Most of them are influenced by sponsors or manufacturers and therefore biased. What's more their conclusions are sometimes highly controversial. Goal of this study is to provide solid evidence on safety of reuse of SUD and to discover differences in in-vitro and clinical outcomes. One of the most common SUD for laparoscopic surgery is ultrasonic scalpel which uses high-frequency jaw vibration which simultaneously coagulates and divides structures with minimal thermal damage to surrounding tissue. One of the best known ultrasonic shears intended for single-use is harmonic scalpel (Ultracision® Ethicon EndoSurgery, Johnson\&Johnson Company). Ultrasonic shears are being refurbished and/or resterilized for repetitive use in limited number of cycles or until become dysfunctional or disintegrate. Routine depends on local regulations and variations in practice. To encourage or to ban aforementioned practice we need solid evidence based on properly conducted clinical trial. Therefore we have designed a single-blind randomised clinical trial depending on virginity of instrument used for tissue dissection. Since Ultracision device is the most commonly used ultrasonic sealing device we decided to study outcomes of surgery performed with the new (unused) instrument versus resterilized reused instrument.
All of the patients with clinical and radiological suspicion of having acute appendicitis will be blindly allocated in two arms according to the predefined random sequence provided by independent statistician. Eligible patients will sign an informed consent form. First arm will have laparoscopic appendectomy with new ultrasonic device. The patient will be blinded for the allocation, but the surgeon can not be blinded since packing of the new and reused instruments differ. Even if the scrub nurse would give surgeon instruments without packing, some minor damage might be seen on the plastic coating of the instrument jaws. The second arm will have laparoscopic appendectomy with reused ultrasonic device. All other treatment including surgical technique, postoperative management and follow-up will be unchanged or within the standard of care. Surgical technique is standardised three-trocar approach in general anesthesia. All other details of the surgery are variable depending on local findings, extent of inflammation, anatomy variations etc. Removed specimens will be analyzed routinely with addition of measurement of lateral thermal damage of mesoappendix and appendiceal base. Patients will be screened for antibiotic therapy length, analgesics consumption, early surgical complications according to Clavien-Dindo classification and length of stay. Additionally one month follow-up will be conducted to pick-up possible late complications or readmissions. Study will be conducted in two centers for a period of time until sufficient number of participants are recruited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| New Device | Active comparator | Device: New DeviceLaparoscopic appendectomy will be done using new ultrasonic shears. |
| Used Device | Experimental | Device: Used DeviceLaparoscopic appendectomy will be done using reprocessed ultrasonic shears. |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of acute appendicitis confirmed during surgery
- Laparoscopic appendectomy
- Operated with UltraCision harmonic scalpel.
Key exclusion criteria (5 listed)
- Finding of innocent (white) appendix
- Pregnancy
- Significant co-morbidity (ASA III-IV)
- Open appendectomy
- Laparoscopic appendectomy using instruments other than Ultracision harmonic scalpel.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New DeviceLaparoscopic appendectomy using new ultrasonic shears. | Device | New Device |
| Used DeviceLaparoscopic appendectomy using reprocessed ultrasonic shears. | Device | Used Device |
Primary outcome
Lateral Thermal Damage of Mesoappendix
Time frame: Through study completion, an average of 1 year.
Microscopically measured distance of lateral thermal damage of mesoappendix
Lateral Thermal Damage of Appendiceal Base
Time frame: Through study completion, an average of 1 year.
Microscopically measured distance of lateral thermal damage of appendiceal base
4 secondary outcomes
Clinical outcome - Postoperative complications
Time frame: Postoperative 30 days follow-up
Clinical outcome - Length of stay
Time frame: Through study completion, an average of 1 year.
Time to transect appendiceal base
Time frame: During the surgery
Rating Device Functionality
Time frame: Immediately after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
- Background: PubMed 20835717Chu T, Chandhoke RA, Smith PC, Schwaitzberg SD. The impact of surgeon choice on the cost of performing laparoscopic appendectomy. Surg Endosc. 2011 Apr;25(4):1187-91. doi: 10.1007/s00464-010-1342-1. Epub 2010 Sep 11.
- Background: PubMed 12063946Dunn D. Reprocessing single-use devices--the ethical dilemma. AORN J. 2002 May;75(5):989-99; quiz 1000-4. doi: 10.1016/s0001-2092(06)61462-2.
- Background: PubMed 21746819Collier R. The ethics of reusing single-use devices. CMAJ. 2011 Aug 9;183(11):1245. doi: 10.1503/cmaj.109-3907. Epub 2011 Jul 11. No abstract available.
- Background: PubMed 20975490Lester BR, Miller K, Boers A, Harris DC, Gamble WG. Comparison of in vivo clinical performance and shaft temperature and in vitro tissue temperature and transection times between new and reprocessed harmonic scalpels. Surg Laparosc Endosc Percutan Tech. 2010 Oct;20(5):e150-9. doi: 10.1097/SLE.0b013e3181eff973.
- Background: PubMed 16698349Weld KJ, Dryer S, Hruby G, Ames CD, Venkatesh R, Matthews BD, Landman J. Comparison of mechanical and in vivo performance of new and reprocessed harmonic scalpels. Urology. 2006 May;67(5):898-903. doi: 10.1016/j.urology.2005.11.027.
- Background: PubMed 30556542Jacobs P, Akpinar I. Single-use medical devices: economic issues. Heart Asia. 2018 Nov 9;10(2):e011034. doi: 10.1136/heartasia-2018-011034. eCollection 2018. No abstract available.
- Background: PubMed 18828937Hailey D, Jacobs PD, Ries NM, Polisena J. Reuse of single use medical devices in Canada: clinical and economic outcomes, legal and ethical issues, and current hospital practice. Int J Technol Assess Health Care. 2008 Fall;24(4):430-6. doi: 10.1017/S0266462308080562.
- Background: PubMed 17323656Sloan TW. Safety-cost trade-offs in medical device reuse: a Markov decision process model. Health Care Manag Sci. 2007 Feb;10(1):81-93. doi: 10.1007/s10729-006-9007-2.
- Background: PubMed 21727228Collier R. Reprocessing single-use devices: an international perspective. CMAJ. 2011 Aug 9;183(11):1244. doi: 10.1503/cmaj.109-3906. Epub 2011 Jul 4. No abstract available.
- Background: PubMed 20471316Popp W, Rasslan O, Unahalekhaka A, Brenner P, Fischnaller E, Fathy M, Goldman C, Gillespie E. What is the use? An international look at reuse of single-use medical devices. Int J Hyg Environ Health. 2010 Jul;213(4):302-7. doi: 10.1016/j.ijheh.2010.04.003. Epub 2010 May 13.
- Background: PubMed 16680715Magetsari R, van der Houwen EB, Bakker MT, van der Mei HC, Verkerke GJ, Rakhorst G, Hilmy CR, van Horn JR, Busscher HJ. Biomechanical and surface physico-chemical analyses of used osteosynthesis plates and screws--potential for reuse in developing countries? J Biomed Mater Res B Appl Biomater. 2006 Nov;79(2):236-44. doi: 10.1002/jbm.b.30534.
- Background: PubMed 12165829Roth K, Heeg P, Reichl R. Specific hygiene issues relating to reprocessing and reuse of single-use devices for laparoscopic surgery. Surg Endosc. 2002 Jul;16(7):1091-7. doi: 10.1007/s00464-001-9190-7. Epub 2002 Apr 9.
- The Reprocessing and Reuse of Single-Use Medical Devices in Newfoundland \& Labrador (2010)Link provided by the sponsor.
- Safety and performance evaluation of remanufactured harmonic scalpels (2010)Link provided by the sponsor.
- Croatian Law on Medical Products 2017/745 (2018) - Article in CroatianLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jakov Mihanovic, MD principal investigator
General Hospital Zadar
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Device and Used Device in people with Appendicitis Acute and Safety Issues, run by University of Split, School of Medicine at 2 sites in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lateral Thermal Damage of Mesoappendix (time frame: Through study completion, an average of 1 year.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04226482, which also lists 41 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2020.