- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07657039
USE LESS, a Comparative Cohort Study of Climate Change Impact From Orthopedic Surgery (USELESS)
USE LESS, a Comparative Cohort Study of Climate Change Impact From Orthopedic Surgery.
Przegląd badań
Status
Warunki
Szczegółowy opis
Background: Human health depends on the stability of Earth's ecological systems. Healthcare, guided by the principle "first do no harm," paradoxically contributes to this destabilization: globally, it accounts for ~5% of greenhouse gas (GHG) emissions, with orthopedic care among the most resource-intensive domains. It is imperative that the health sector finds ways to reduce emissions while still providing care with preserved quality and quantity. Use of single-use materials has been found to yield a significant part of emissions from orthopedic surgeries. Performing minor surgeries in procedure rooms instead of the operating room can reduce emissions and waste. Moreover, a small portion of products accounts for most of an operation's carbon footprint, suggesting that targeted measures may have substantial impact.
Carbon emission represents only one dimension of healthcare's environmental burden. Life Cycle Assessment (LCA) enables quantification of impacts across categories such as toxicity, particulate matter formation, resource depletion, water consumption, land use, ozone formation, and ecosystem effects. These categories are relevant in orthopedics, where products commonly contain e.g. polyvinyl chloride (PVC), di(2-ethylhexyl) phthalate (DEHP), and per- and polyfluoroalkyl substances (PFAS). Moreover, large quantities of nonrecyclable plastics are used. Transitioning from single-use to reusable products can reduce GHG emissions significantly, though further studies are needed to ensure clinical safety.
Carbon emission represents only one dimension of healthcare's environmental burden. Life Cycle Assessment (LCA) enables quantification of impacts across categories such as toxicity, particulate matter formation, resource depletion, water consumption, land use, ozone formation, and ecosystem effects. These categories are relevant in orthopedics, where products commonly contain e.g. polyvinyl chloride (PVC), di(2-ethylhexyl) phthalate (DEHP), and per- and polyfluoroalkyl substances (PFAS). Moreover, large quantities of nonrecyclable plastics are used [9]. Transitioning from single-use to reusable products can reduce GHG emissions significantly, though further studies are needed to ensure clinical safety. Population: Age ≥18 years undergoing release of carpal tunnel or trigger finger, wound revision or amputation of finger or toe, extraction of osteosynthesis material or suturing of extensor tendon (hand or foot) at Danderyd's Hospital. There are no exclusion criteria.
Intervention: Procedures performed in a procedure room using a reduced material set at the outpatient clinic under local anesthetics only. Control: Procedures performed in an operating room (OR) using a standard OR set up with available anesthesiology assistance.
This study hopes to answer the question: How do climate change impact differ between minor orthopedic procedures performed in a conventional operating theatre compared with procedures in an outpatient clinic procedure room with a reduced set of material?
Primary outcome: CO₂e per functional unit. Secondary outcomes: Complications (infection, readmission), combustible waste (kg) and costs (staff and material). Hotspot analysis identifying major contributors to emissions. The functional unit is defined as one performed surgery.
Environmental impacts will be assessed using Life Cycle Assessment (LCA) according to the four standard phases: (1) goal and scope definition, (2) life cycle inventory (LCI), (3) life cycle impact assessment (LCIA), and (4) interpretation including sensitivity and uncertainty analyses. System boundaries will be cradle-to-grave when complete data are available and otherwise gate-to-gate for single-use products lacking published LCAs. Identical system boundaries will be applied within each study to ensure comparability between intervention and control groups. Life cycle inventories will include materials, pharmaceuticals, reusable and single-use equipment, sterilization, energy consumption, waste handling, inpatient care, and staffing. Detailed inventories of surgical procedures will be collected prospectively at Danderyd Hospital, including article numbers, quantities, and weights of materials, as well as disposal weights. CO₂e emissions will primarily be calculated using manufacturer LCAs; where unavailable, emissions will be estimated from material composition and weight using established databases (e.g., Inventory of Carbon and Energy) and published templates for reusable materials and energy use. Mean emissions per procedure or treatment pathway will be calculated and compared between groups.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Marianne Smith, MD
- Numer telefonu: +46737803594
- E-mail: marianne.smith@regionstockholm.se
Lokalizacje studiów
-
-
-
Stockholm, Szwecja
- Rekrutacyjny
- Danderyd's Hospital
-
Kontakt:
- Marianne Smith
- Numer telefonu: +46737803594
- E-mail: marianne.smith@regionstockholm.se
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
- The following surgeries will be included: release of carpal tunnel or trigger finger, wound revision or amputation of finger or toe, extraction of osteosynthesis material or suturing of extensor tendon (hand or foot) at Danderyd's Hospital.
Exclusion Criteria:
- None
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
|---|
|
Control group
Patients undergoing surgical procedures in an operating room at the day surgery department
|
|
Intervention group
Patients undergoing surgical procedures in the procedure room at the orthopedic outpatient clinic
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Climate change impact
Ramy czasowe: Data cwill be collected during 12 months for each group
|
Mean carbon dioxide equivalent (CO₂e) emissions expressed in kgs per functional unit defined as one performed surgery.
All single-use materials consumed during an operation will be registrered, categorized, weighted and converted into CO₂e using exsisting LCAs or databases.
Energy comsuption for machines in the OR, heating and ventilation of the OR and for sterilization of reusable materials will be converted into CO2e using existing databases.
Water usage for sterilization will be calculated and converted into CO₂e using databases.
|
Data cwill be collected during 12 months for each group
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Readmission
Ramy czasowe: within 90 days of the performed sugery
|
Readmission to hospital within 90 days of the procedure.
Admission cause must be related the surgical proceure, e.g.
surgical site infection demanding iv antibiotics.
|
within 90 days of the performed sugery
|
|
Combustible waste
Ramy czasowe: All consecutive suergeries for twelve months in each group
|
Weight of waste generated after each surgery measured in kgs.
Staff in the OR will collect all waste in one or two plastic bags and weigh them using a hade scale INF model KBE-BHC025-11 D hand scale.
The weight is recorded in kilograms in the study protocol in the OR.
|
All consecutive suergeries for twelve months in each group
|
|
Costs
Ramy czasowe: All consecutive suergeries for twelve months in each group
|
Difference in costs for material and staff.
Costs for all singe-use items will be collected from the purcahse department and recorded in SEK intitiallt before conversion to € at the time or data analysis.
Costs for reuseable items will be collected and a value calculated for each usage will be obtained.
Energy usage will be calculated in kWh and water consumtion will be measured in cubic meters and a converted into SEK/€ using price lists obtained from the Hospital.
A mean value for costs for each staff category (e.g.
doctor, nurse) per hour will be obtained from the hospital and mutiplied by the OR time.
|
All consecutive suergeries for twelve months in each group
|
|
Infections
Ramy czasowe: Within 90 days of surgery
|
Surgical site infection following the procedure.
Patients charts will be examined after 90 days and if any antibiotics covering skin pathogens (e.g.
Flukloxacillin, Clindamycin) has been perscribed by any caregiver during the period it will be assumed to be a positive value.
|
Within 90 days of surgery
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Hotspot analysis
Ramy czasowe: All consecutive suergeries for twelve months in each group
|
Identification of major contributors to emissions by categorizing all activity data that contributes to emissions and calculated as a percentage of the primary endpoint; CO₂e expressed i kgs per fuctional unit (one surgery).
Categories will include but not be restricted to; single-use items, manufacturing and usage of reusable items, egergy comsuption by machines in the OR, energy comsuption for heating and ventilation and energy and water consumption for sterilization of resuable items.
|
All consecutive suergeries for twelve months in each group
|
Współpracownicy i badacze
Sponsor
Publikacje i pomocne linki
Publikacje ogólne
- Keil M, Viere T, Helms K, Rogowski W. The impact of switching from single-use to reusable healthcare products: a transparency checklist and systematic review of life-cycle assessments. Eur J Public Health. 2023 Feb 3;33(1):56-63. doi: 10.1093/eurpub/ckac174.
- 8: Ted Schettler, M., Polyvinyl chloride in health care. 2020.
- 7: WOLF, M.-A., et al., International reference life cycle data system (ILCD) handbook-general guide for life cycle assessment-detailed guidance. 2010.
- Rizan C, Lillywhite R, Reed M, Bhutta MF. The carbon footprint of products used in five common surgical operations: identifying contributing products and processes. J R Soc Med. 2023 Jun;116(6):199-213. doi: 10.1177/01410768231166135. Epub 2023 Apr 13.
- Grothaus O, Jorgensen A, Maughan G, Anto M, Kazmers NH, Garcia BN. Carbon Footprint of Open Carpal Tunnel Release Surgery Performed in the Procedure Room Versus Operating Room Setting. J Hand Surg Am. 2024 Jun;49(6):576-582. doi: 10.1016/j.jhsa.2024.03.014. Epub 2024 May 6.
- Rizan C, Steinbach I, Nicholson R, Lillywhite R, Reed M, Bhutta MF. The Carbon Footprint of Surgical Operations: A Systematic Review. Ann Surg. 2020 Dec;272(6):986-995. doi: 10.1097/SLA.0000000000003951.
- 3: Boiko, P., et al., Environmental life cycle assessment of surgical versus conservative care pathways for an anterior cruciate ligament injury. Journal of cleaner production, 2025. 535: p. 147136.
- Eidmann A, Geiger F, Heinz T, Jakuscheit A, Docheva D, Horas K, Stratos I, Rudert M. Our Impact on Global Warming: A Carbon Footprint Analysis of Orthopaedic Operations. J Bone Joint Surg Am. 2024 Nov 6;106(21):1971-1977. doi: 10.2106/JBJS.24.00212. Epub 2024 Sep 19.
- 1:Pichler, P.-P., et al., International comparison of health care carbon footprints. Environmental research letters, 2019. 14(6): p. 064004
- Shah S, Morris H, Thiagarajah S, Gordon A, Sharma S, Haslam P, Garcia J, Ali F. Handling 'carbon footprint' in orthopaedics. Ann R Coll Surg Engl. 2024 Jul;106(6):498-503. doi: 10.1308/rcsann.2023.0052. Epub 2024 Apr 2.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 2025-02587-01
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .