Pressure UlcerNCT03442777
Silicone Adhesive Multilayer Foam Dressings to Prevent Pressure Ulcer
A study testing Allevyn® brand silicone adhesive multilayer foam dressings and Mepilex® brand silicone adhesive multilayer foam dressings in people with Pressure Ulcer, run by Belgium Health Care Knowledge Centre at 8 sites in Belgium.
Trial summary
The objective of this study is to determine if silicone adhesive multilayer foam dressings applied to the sacrum, heels and greater trochanter in addition to standard prevention reduce pressure ulcer incidence category II, III, IV, Unstageable and Deep Tissue Injury (DTI) compared to standard pressure ulcer prevention… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Allevyn® brand silicone adhesive multilayer foam dressings and Mepilex® brand silicone adhesive multilayer foam dressings
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,634 participants
- Where
- 8 sitesBelgium
- Study dates
- 8 Feb 2018to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At risk for pressure ulcer development based on Braden risk assessment (Braden score ≤17).
- Admitted to hospital within the previous 48 hours. Note: Not more than 25% of patients per site should be recruited at ICU wards.
- Skin at sacrum is assessable and there is no clinically relevant incontinence- associated dermatitis (IAD*) or another skin condition that would be a contra-indication for the application of the devices under study, and there is no pressure ulcer category II or worse present.
- clinically relevant IAD is defined as any of the 4 categories described in the publication http://users.ugent.be/~dibeeckm/globiadnl/nlv1.0.pdf
- For at least 3 of the following 4 skin sites (heel left, heel right, greater trochanter left, greater trochanter right) one of the following two conditions should apply:
- A study dressing can be applied as prevention of a pressure ulcer category II or worse at that skin site (there is no contra-indication)
Show all 9Show fewer
- OR
- There is already a pressure ulcer category II or worse at that skin site.
- Written informed consent by the patient or his/her legal representative.
Who cannot join
- Aged < 18 years.
- The length of stay counting from first day of admission in one or (if the patient is transferred to another ward) more participating wards is < 7 days.
- Both heels amputated
- Previously known/documented allergy for substances used in the devices under study.
- A clinical condition not allowing participation in a clinical study.
- Participation in another interventional clinical trial.
- Patients who exceptionally receive or are planned to receive a dressing for the prevention of pressure ulcers at sacrum, heels and trochanters based on best medical judgment and outside of the surgery setting.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Belgium8 sites
OLV Aalst
Aalst, 9300
AZ Maria Middelares Ghent
Ghent, 9000
University of Ghent
Ghent, 9000
UZ Brussel
Jette, 1090
AZ Groeninge
Kortrijk, 8500
UZ Leuven
Leuven, 3000
OLV van Lourdes Ziekenhuis Waregem
Waregem, 8790
AZ Sint-Elisabeth Zottegem
Zottegem, 9620
About this study
Official title: Silicone Adhesive Multilayer Foam Dressings as Adjuvant Prophylactic Therapy for Pressure Ulcer (PU) Prevention: a Multicentric Randomised Open Label Parallel Group Medical Device Trial in Hospitalised Patients at Risk of PU Development
The objective of this study is to determine if silicone adhesive multilayer foam dressings applied to the sacrum, heels and greater trochanter in addition to standard prevention reduce pressure ulcer incidence category II, III, IV, Unstageable and Deep Tissue Injury (DTI) compared to standard pressure ulcer prevention alone, in at risk hospitalised patients. In particular, this trial extends previous trial results obtained in ICU setting. Therefore, only a maximum of 25% of patients will be recruited from ICU settings.
The hypothesis is: 'The use of silicone adhesive multilayer foam dressings as adjuvant prophylactic therapy for pressure ulcer prevention is more effective in reducing pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) incidence rate on sacrum, heels and greater trochanter, compared to standard pressure ulcer prevention alone.' The null hypothesis is: 'The use of silicone adhesive multilayer foam dressings as adjuvant prophylactic therapy for pressure ulcer prevention is not more effective in reducing pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) incidence rate on sacrum, heels and greater trochanter, compared to standard pressure ulcer prevention alone.
Read the detailed description
A multicentre randomised controlled open label parallel group medical device trial in approximately 8 hospitals in Belgium.
Patients will be randomly allocated to three study arms based on a 1:1:1 allocation:
Study arm 1 (on top of standard of care):
- Patients at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will receive standard pressure ulcer prevention strategies (as described in the hospital protocol) which include ongoing risk assessment, regular repositioning and skin care.
- Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Smith \& Nephew (Allevyn® brand).
Study arm 2 (on top of standard of care):
- Patients at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will receive standard pressure ulcer prevention strategies (as described in the hospital protocol) which include ongoing risk assessment, regular repositioning and skin care.
- Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Mölnlycke Health care (Mepilex® brand).
Study arm 3 (standard of care):
- Patients at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will receive standard pressure ulcer prevention strategies (as described in the hospital protocol) which include ongoing risk assessment, regular repositioning and skin care.
- No silicone adhesive multilayer foam dressings will be applied on the skin sites of interest for this trial (sacrum, heel right/left, greater trochanter right/left).
Skin sites (restricted to sacrum, heel right/left, greater trochanter right/left) of patients at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will be assessed daily for a maximum period of 14 days.
- Conditions
- Pressure Ulcer
- Being tested
- Allevyn® brand silicone adhesive multilayer foam dressings, Mepilex® brand silicone adhesive multilayer foam dressings
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allevyn® brand silicone adhesive multilayer foam dressingsDevice
Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Smith\&Nephew (Allevyn® brand).
Mepilex® brand silicone adhesive multilayer foam dressingsDevice
Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Mölnlycke Health care (Mepilex® brand).
| Study group | Role | What they receive |
|---|---|---|
| Study Arm 1 (on top of standard of care) | Experimental | Allevyn® brand silicone adhesive multilayer foam dressings
* Patients at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will receive standard pressure ulcer prevention strategies (as described in the hospital protocol) which include ongoing risk assessment, regular repositioning and skin care.
* Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Smith \& Nephew (Allevyn® brand). Receives: Device: Allevyn® brand silicone adhesive multilayer foam dressings |
| Study Arm 2 (on top of standard of care) | Experimental | Mepilex® brand silicone adhesive multilayer foam dressings
* Patients at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will receive standard pressure ulcer prevention strategies (as described in the hospital protocol) which include ongoing risk assessment, regular repositioning and skin care.
* Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Mölnlycke Health care (Mepilex® brand). Receives: Device: Mepilex® brand silicone adhesive multilayer foam dressings |
| Study Arm 3 (standard of care) | No intervention | * Patients at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will receive standard pressure ulcer prevention strategies (as described in the hospital protocol) which include ongoing risk assessment, regular repositioning and skin care. * No silicone adhesive multilayer foam dressings will be applied on the skin sites of interest for this trial (sacrum, heel right/left, greater trochanter right/left). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Sacrum, Heels or Greater Trochanter
The number of participants who developed at least one new pressure ulcer of category 2 or worse on sacrum, heels or greater trochanter as judged onsite, during the study period (maximum 14 days).
Patients in experimental groups 1 and 2 were pooled as the treatment group and compared to the control group (in the intention to treat population (n=1605)
Note: The International NPUAP/EPUAP Pressure Ulcer Classification System (National Pressure Ulcer Advisory Panel (2014)) distinguishes four categories of pressure ulcers: non-blanchable erythema of the intact skin (category I), partial thickness loss of dermis (category II), full thickness tissue loss (category III) and full thickness tissue loss with exposed bone, tendon or muscle (category IV). Also unstageable pressure ulcers and deep tissue injuries can be recognised. https://npiap.com/
Measured: assessment during 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2018
- Study start8 Feb 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pressure UlcerStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients will be allocated to 1 of the 3 study arms based on a 1:1:1 allocation
- Masking
- None (open label)
- Enrolment
- 1,634 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belgium Health Care Knowledge Centre
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Dimitri Beeckman, Principal investigator, Ugent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03442777
- Sponsor's protocol ID
- KCE-16012
- Status last verified
- Mar 2021
- First submitted
- 16 Feb 2018
- Last updated
- 26 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Access will be granted to non-commercial researchers who provide a methodologically sound proposal for a relevant research questions. Relevance will be assessed by the Sponsor in collaboration with the Chief investigator.
Publications
Beeckman D, Fourie A, Raepsaet C, Van Damme N, Manderlier B, De Meyer D, Beele H, Smet S, Demarre L, Vossaert R, de Graaf A, Verhaeghe L, Vandergheynst N, Hendrickx B, Hanssens V, Keymeulen H, Vanderwee K, Van De Woestijne J, Verhaeghe S, Van Hecke A, Savoye I, Harrison J, Vrijens F, Hulstaert F. Silicone adhesive multilayer foam dressings as adjuvant prophylactic therapy to prevent hospital-acquired pressure ulcers: a pragmatic noncommercial multicentre randomized open-label parallel-group medical device trial. Br J Dermatol. 2021 Jul;185(1):52-61. doi: 10.1111/bjd.19689. Epub 2020 Dec 28.
PubMed 33216969
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Silicone Adhesive Multilayer Foam Dressings as Adjuvant Prophylactic Therapy for Pressure Ulcer (PU) Prevention: a Multicentric Randomised Open Label Parallel Group Medical Device Trial in Hospitalised Patients at Risk of PU Development
- ClinicalTrials.gov ID
- NCT03442777
- Acronym / sponsor ID
- KCE-16012
- Conditions
- Pressure Ulcer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,634 participants (actual)
- Lead sponsor
- Belgium Health Care Knowledge CentreOther government
- Study start
- 8 Feb 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 22 Feb 2018 (actual)
- Results
- Posted 26 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine if silicone adhesive multilayer foam dressings applied to the sacrum, heels and greater trochanter in addition to standard prevention reduce pressure ulcer incidence category II, III, IV, Unstageable and Deep Tissue Injury (DTI) compared to standard pressure ulcer prevention alone, in at risk hospitalised patients. In particular, this trial extends previous trial results obtained in ICU setting. Therefore, only a maximum of 25% of patients will be recruited from ICU settings.
The hypothesis is: 'The use of silicone adhesive multilayer foam dressings as adjuvant prophylactic therapy for pressure ulcer prevention is more effective in reducing pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) incidence rate on sacrum, heels and greater trochanter, compared to standard pressure ulcer prevention alone.' The null hypothesis is: 'The use of silicone adhesive multilayer foam dressings as adjuvant prophylactic therapy for pressure ulcer prevention is not more effective in reducing pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) incidence rate on sacrum, heels and greater trochanter, compared to standard pressure ulcer prevention alone.
Detailed description
A multicentre randomised controlled open label parallel group medical device trial in approximately 8 hospitals in Belgium.
Patients will be randomly allocated to three study arms based on a 1:1:1 allocation:
Study arm 1 (on top of standard of care):
- Patients at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will receive standard pressure ulcer prevention strategies (as described in the hospital protocol) which include ongoing risk assessment, regular repositioning and skin care.
- Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Smith \& Nephew (Allevyn® brand).
Study arm 2 (on top of standard of care):
- Patients at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will receive standard pressure ulcer prevention strategies (as described in the hospital protocol) which include ongoing risk assessment, regular repositioning and skin care.
- Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Mölnlycke Health care (Mepilex® brand).
Study arm 3 (standard of care):
- Patients at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will receive standard pressure ulcer prevention strategies (as described in the hospital protocol) which include ongoing risk assessment, regular repositioning and skin care.
- No silicone adhesive multilayer foam dressings will be applied on the skin sites of interest for this trial (sacrum, heel right/left, greater trochanter right/left).
Skin sites (restricted to sacrum, heel right/left, greater trochanter right/left) of patients at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will be assessed daily for a maximum period of 14 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- patients will be allocated to 1 of the 3 study arms based on a 1:1:1 allocation
| Arm | Type | Receives |
|---|---|---|
| Study Arm 1 (on top of standard of care) | Experimental | Device: Allevyn® brand silicone adhesive multilayer foam dressingsAllevyn® brand silicone adhesive multilayer foam dressings * Patients at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will receive standard pressure ulcer prevention strategies (as described in the hospital protocol) which include ongoing risk assessment, regular repositioning and skin care. * Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Smith \& Nephew (Allevyn® brand). |
| Study Arm 2 (on top of standard of care) | Experimental | Device: Mepilex® brand silicone adhesive multilayer foam dressingsMepilex® brand silicone adhesive multilayer foam dressings * Patients at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will receive standard pressure ulcer prevention strategies (as described in the hospital protocol) which include ongoing risk assessment, regular repositioning and skin care. * Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Mölnlycke Health care (Mepilex® brand). |
| Study Arm 3 (standard of care) | No intervention | –* Patients at risk for pressure ulcer category II, III, IV, Unstageable, and Deep Tissue Injury (DTI) development will receive standard pressure ulcer prevention strategies (as described in the hospital protocol) which include ongoing risk assessment, regular repositioning and skin care. * No silicone adhesive multilayer foam dressings will be applied on the skin sites of interest for this trial (sacrum, heel right/left, greater trochanter right/left). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At risk for pressure ulcer development based on Braden risk assessment (Braden score ≤17).
- Admitted to hospital within the previous 48 hours. Note: Not more than 25% of patients per site should be recruited at ICU wards.
- Skin at sacrum is assessable and there is no clinically relevant incontinence- associated dermatitis (IAD*) or another skin condition that would be a contra-indication for the application of the devices under study, and there is no pressure ulcer category II or worse present.
- clinically relevant IAD is defined as any of the 4 categories described in the publication http://users.ugent.be/~dibeeckm/globiadnl/nlv1.0.pdf
- For at least 3 of the following 4 skin sites (heel left, heel right, greater trochanter left, greater trochanter right) one of the following two conditions should apply:
Key exclusion criteria (7 listed)
- Aged < 18 years.
- The length of stay counting from first day of admission in one or (if the patient is transferred to another ward) more participating wards is < 7 days.
- Both heels amputated
- Previously known/documented allergy for substances used in the devices under study.
- A clinical condition not allowing participation in a clinical study.
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 |
|---|---|---|
| Allevyn® brand silicone adhesive multilayer foam dressingsSkin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Smith\&Nephew (Allevyn® brand). | Device | Study Arm 1 (on top of standard of care) |
| Mepilex® brand silicone adhesive multilayer foam dressingsSkin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Mölnlycke Health care (Mepilex® brand). | Device | Study Arm 2 (on top of standard of care) |
Primary outcome
Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Sacrum, Heels or Greater Trochanter
Time frame: assessment during 14 days
The number of participants who developed at least one new pressure ulcer of category 2 or worse on sacrum, heels or greater trochanter as judged onsite, during the study period (maximum 14 days). Patients in experimental groups 1 and 2 were pooled as the treatment group and compared to the control group (in the intention to treat population (n=1605) Note: The International NPUAP/EPUAP Pressure Ulcer Classification System (National Pressure Ulcer Advisory Panel (2014)) distinguishes four categories of pressure ulcers: non-blanchable erythema of the intact skin (category I), partial thickness loss of dermis (category II), full thickness tissue loss (category III) and full thickness tissue loss with exposed bone, tendon or muscle (category IV). Also unstageable pressure ulcers and deep tissue injuries can be recognised. https://npiap.com/
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 33216969Beeckman D, Fourie A, Raepsaet C, Van Damme N, Manderlier B, De Meyer D, Beele H, Smet S, Demarre L, Vossaert R, de Graaf A, Verhaeghe L, Vandergheynst N, Hendrickx B, Hanssens V, Keymeulen H, Vanderwee K, Van De Woestijne J, Verhaeghe S, Van Hecke A, Savoye I, Harrison J, Vrijens F, Hulstaert F. Silicone adhesive multilayer foam dressings as adjuvant prophylactic therapy to prevent hospital-acquired pressure ulcers: a pragmatic noncommercial multicentre randomized open-label parallel-group medical device trial. Br J Dermatol. 2021 Jul;185(1):52-61. doi: 10.1111/bjd.19689. Epub 2020 Dec 28.
- Individual participant dataSharing planned: Yes. Access will be granted to non-commercial researchers who provide a methodologically sound proposal for a relevant research questions. Relevance will be assessed by the Sponsor in collaboration with the Chief investigator.
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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.
Dimitri Beeckman principal investigator
Ugent
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allevyn® brand silicone adhesive multilayer foam dressings and Mepilex® brand silicone adhesive multilayer foam dressings in people with Pressure Ulcer, run by Belgium Health Care Knowledge Centre at 8 sites in Belgium.
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 9 inclusion and 7 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 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Belgium. 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?
Yes. Results are posted in the registry (first posted 26 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Who Developed a New Pressure Ulcer Category 2 or Worse on Sacrum, Heels or Greater Trochanter (time frame: assessment during 14 days). 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 NCT03442777, which also lists 1 linked publication.
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 26 Apr 2021; AzTrials last refreshed its copy on 8 Nov 2026.