Prospective Randomized Evaluation of Emerging Novel Treatments for Infection prophylaxis in Total Joint Replacement (PREVENT-iT)

2024-515055-38-00 Protocol PiT-023 Therapeutic confirmatory (Phase III) Ongoing, recruiting

Start 13 Feb 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 13 sites · Protocol PiT-023

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruiting
Participants planned 21,056
Countries 1
Sites 13

Adult patients undergoing TJR surgery.

To determine in patients undergoing primary or aseptic revision TJR if: 1. A 0.35% PI irrigation solution compared to a normal saline irrigation solution reduces the risk of reoperation due to infection within 12 months of primary or aseptic revision hip or knee TJR. 2. A 0.05% chlorhexidine irrigation solution compar…

Key facts

Sponsor
Hamilton Health Sciences Corporation
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Bacterial Infections and Mycoses [C01], Diseases [C] - Musculoskeletal Diseases [C05]
Trial duration
13 Feb 2025 → ongoing
Decision date (initial)
2024-10-08
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Prophylaxis

To determine in patients undergoing primary or aseptic revision TJR if:
1. A 0.35% PI irrigation solution compared to a normal saline irrigation solution reduces the risk of reoperation due to infection within 12 months of primary or aseptic revision hip or knee TJR.
2. A 0.05% chlorhexidine irrigation solution compared to a normal saline irrigation solution reduces the risk of reoperation due to infection within 12 months of primary or aseptic revision hip or knee TJR.
3. The use of local vancomycin versus no local vancomycin reduces the risk of reoperation due to infection within 12 months of primary or aseptic revision hip or knee TJR.

Secondary objectives 3

  1. To determine the impact of a 0.35% PI irrigation solution compared to a normal saline irrigation solution on the number of non-operative surgical site infections requiring antibiotics.
  2. To determine the impact of a 0.05% chlorhexidine irrigation solution compared to a normal saline irrigation solution on the number of non-operative surgical site infections requiring antibiotics.
  3. Patients who receive local vancomycin will have a lower rate of infection requiring reoperation compared to patients who did not receive local vancomycin.

Conditions and MedDRA coding

Adult patients undergoing TJR surgery.

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 Multi-center pragmatic 3 x 2 factorial randomized controlled trial
Multi-center pragmatic 3 x 2 factorial randomized controlled trial
 Randomised Controlled None Povidone-iodine lavage and local vancomycin: Povidone-iodine lavage and local vancomycin
Chlorhexidine lavage and local vancomycin: Chlorhexidine lavage and local vancomycin
Normal saline lavage and local vancomycin: Normal saline lavage and local vancomycin
Povidone-iodine lavage with no local vancomycin: Povidone-iodine lavage with no local vancomycin
Chlorhexidine lavage with no local vancomycin: Chlorhexidine lavage with no local vancomycin
Normal saline lavage with no local vancomycin: Normal saline lavage with no local vancomycin

Regulatory references

Plan to share IPD
No
EU CT numberTitleSponsor
2022-000663-45 Prospective Randomized Evaluation of Emerging Novel Treatments for Infection prophylaxis in Total Joint Replacement (PREVENT-iT): A Pilot Study, Evaluación aleatoria prospectiva de nuevos tratamientos emergentes para la profilaxis de infecciones en el reemplazo total de articulaciones: un estudio piloto (PREVENT-iT)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

  1. Patients 18 years of age or older.
  2. Undergoing primary or aseptic revision TJR

Exclusion criteria 11

  1. Received antibiotics for any reason in the two weeks prior to their TJR.
  2. A contraindication to study interventions.
  3. Chronic or acute infection at or near the TJR site.
  4. Prior history of periprosthetic joint infection including any reoperation due to infection.
  5. Undergoing surgery for a diagnosis of a fracture.
  6. Open infected wounds on affected limb
  7. Undergoing bilateral TJR.
  8. Currently enrolled in a study that does not permit co-enrollment
  9. Did not provide informed consent.
  10. Prior enrollment in the trial including the pilot study.
  11. Any condition or circumstance, which in the opinion of the Investigator, interferes with assessments or completion of the trial.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. The primary outcome is infection that requires reoperation within 12 months of TJR.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Povidone

SUB12238MIG · Substance

Active substance
Povidone
Pharmaceutical form
CUTANEOUS SOLUTION
Route of administration
CUTANEOUS USE
Max daily dose
0.35 % percent
Max total dose
0.35 % percent
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

-

B05XX · Product

Pharmaceutical form
PHF00230MIG
Route of administration
CUTANEOUS USE
Max daily dose
0.9 % (W/V) percent weight/volume
Max total dose
0.9 % (W/V) percent weight/volume
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
B05XX — OTHER I.V. SOLUTION ADDITIVES
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Benzalkonium Chloride

SCP102630297 · ATC

Active substance
Benzalkonium Chloride
Substance synonyms
BENZALKONIUM CHLORATUM, ALKYLBENZYLDIMETHYLAMMONIUM CHLORIDE
Route of administration
CUTANEOUS USE
Max daily dose
0.05 % (W/V) percent weight/volume
Max total dose
0.05 % (W/V) percent weight/volume
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
D08AC02 — CHLORHEXIDINE
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Vancomycin

SCP148257 · ATC

Active substance
Vancomycin
Substance synonyms
VANCOMYCINUM
Route of administration
CUTANEOUS USE
Max daily dose
2 g gram(s)
Max total dose
2 g gram(s)
Max treatment duration
1 Day(s)
Authorisation status
Authorised
ATC code
J01XA01 — VANCOMYCIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Hamilton Health Sciences Corporation

7 Total trials 6 Recruiting
Academic / Non-commercial
Sponsor organisation
Hamilton Health Sciences Corporation
Address
100 King Street West
City
Hamilton
Postcode
L8P 1A2
Country
Canada

Scientific contact point

Organisation
Hamilton Health Sciences Corporation
Contact name
Dr. Thomas Wood

Public contact point

Organisation
Hamilton Health Sciences Corporation
Contact name
Irene Portas

Locations

1 EU/EEA country · 13 investigational sites

By country

CountryMS statusPlanned subjectsSites
Spain Ongoing, recruiting 325 13
Rest of world
Canada, United Kingdom
 — 20,731 —

Investigational sites

Spain

13 sites · Ongoing, recruiting
Hospital Clinic De Barcelona
Orthopedic Surgery and Traumatology Service (Knee Unit), Calle Villarroel 170, 08036, Barcelona
Hospital Universitari Vall D Hebron
Orthopedic Surgery and Traumatology Service (Hip Unit), Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Clinic De Barcelona
Orthopedic Surgery and Traumatology Service (Hip Unit), Calle Villarroel 170, 08036, Barcelona
Hospital Universitari Vall D Hebron
Orthopedic Surgery and Traumatology Service (Knee Unit), Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital General Universitario Gregorio Maranon
Orthopedic Surgery and Traumatology Service (Knee Unit), Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Universitario Principe De Asturias
Orthopedic Surgery and Traumatology Service (Knee Unit), Carretera Meco S/n, 28805, Alcala De Henares
Hospital Universitario Infanta Leonor
Orthopedic Surgery and Traumatology Service (Knee Unit), Avenida Gran Via Del Este 80, 28031, Madrid
Hospital San Juan De Dios Santurtzi
Orthopedic Surgery and Traumatology Service (Knee Unit), Avenida De Cristobal De Murrieta 70, 48980, Santurtzi
Hospital Universitario La Paz
Orthopedic Surgery and Traumatology Service (Knee Unit), Paseo De La Castellana 261, 28046, Madrid
Fundacio Assistencial De Mutua De Terrassa Fpc
Orthopedic Surgery and Traumatology Service (Knee Unit), Calle De San Antonio No 32, 08221, Terrassa
Consorci Sanitari De Terrassa
Orthopedic Surgery and Traumatology Service (Knee Unit), Carretera De Torrebonica S/N, 08227, Terrassa
Parc Sanitari Sant Joan De Deu
Orthopedic Surgery and Traumatology Service (Knee Unit), Calle Del Doctor Antoni Pujadas 42, 08830, Sant Boi De Llobregat
Consorci Sanitari De L'Alt Penedes I Garraf
Orthopedic Surgery and Traumatology Service (Knee Unit), Calle Espirall 61, 08720, Vilafranca Del Penedes

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Spain 2025-02-13 2025-03-19

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 16 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol ENG_2024-515055-38-00 for publication 3.0
Protocol (for publication) D1_Protocol_EU-CT_20245150553800_clean 4.0
Protocol (for publication) D1_Protocol_EU-CT_20245150553800-track changes 4.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_for publication 1
Subject information and informed consent form (for publication) L1_SIS and ICF General Annex 1_ES_for publication 1
Subject information and informed consent form (for publication) L1_SIS and ICF General_Spanish_clean 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF General_Spanish_track changes 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Annex 1_Spanish_clean 3.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Annex 1_Spanish_track changes 3.0
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_clorhexidina_for publication 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_povidona iodada_for publication 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_suero fisiologico_for publication 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC_vancomicina_for publication 1
Synopsis of the protocol (for publication) D1_Protocol synopsis ESP_2024-515055-38-00_for publication 3.0
Synopsis of the protocol (for publication) D1_Protocol synopsis Spanish_ EU-CT_20245150553800_clean 4.0
Synopsis of the protocol (for publication) D1_Protocol synopsis Spanish_ EU-CT_20245150553800_track changes 4.0

Application history

4 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-06-25 Spain Acceptable
2024-10-02
 2024-10-08
2 SUBSTANTIAL MODIFICATION SM-1 2025-02-03 Spain Acceptable 2025-03-04
3 SUBSTANTIAL MODIFICATION SM-2 2025-06-26 Spain Acceptable 2025-07-30
4 SUBSTANTIAL MODIFICATION SM-3 2026-03-11 Spain Acceptable
2026-04-27
 2026-04-27

Related clinical trials