Acute Fracture SurgeryNCT00986791
Alcohol Cessation Intervention in an Acute Surgical Setting
A study testing GSP-A in people with Acute Fracture Surgery and Alcohol Cessation Intervention, run by Bispebjerg Hospital at 3 sites in Denmark.
Trial summary
Hazardous alcohol intake is an independent risk factor for postoperative complications after major and minor operations, elective and emergency procedures for men and women. The aim of this study is to evaluate the effect of a 6-week Gold Standard Programme for alcohol cessation intervention in the perioperative… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Fracture Surgery, Alcohol Cessation Intervention, Postoperative Complications
- What is being tested?
- GSP-A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 3 sitesDenmark
- Study dates
- May 2010to Mar 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Drinking 21 or more drinks(one drink containing 12 g ethanol) per week for at least 3 months
- Traumatic ankle fracture requiring internal fixation (osteosynthesis; more than just Kirschner threads or similar minor intervention)
- Informed consent
- Randomisation within 36 hours after entering the orthopaedic department
Who cannot join
- Major trauma involving other fractures or major lesions,
- Preoperative severe psychiatric disorders (including medicine addiction, severe alcohol dependence [defined as experience of delirium or seizures during abstinence from alcohol], dementia) or other conditions of reduced ability for giving informed consent
- Pathological fractures
- Pregnancy and lactation
- Allergy to benzodiazepines, anaesthesia, pain treatment or disulfiram
- Uncompensated chronic diseases (including fulminate cardiac or liver insufficiency, which are contraindications for disulfiram)
Show all 9Show fewer
- ASA score 4-5
- Canceled operation
- Withdrawal of informed consent
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Hospital Of South West Denmark
Aabenraa
Bispebjerg University Hospital
Copenhagen
Hvidovre University Hospital
Hvidovre, Copenhagen, 2650
About this study
Official title: Scand-Ankle: A Gold Standard Programme for Alcohol Cessation Intervention in Patients Undergoing Acute Fracture Surgery - A Randomised Clinical Multi-centre Study
Hazardous alcohol intake is an independent risk factor for postoperative complications after major and minor operations, elective and emergency procedures for men and women.
The aim of this study is to evaluate the effect of a 6-week Gold Standard Programme for alcohol cessation intervention in the perioperative period compared to the daily routine guidelines for patients with hazardous alcohol intake undergoing ankle fracture surgery.
- Conditions
- Acute Fracture Surgery, Alcohol Cessation Intervention, Postoperative Complications, Infection, Ankle Injuries
- Being tested
- GSP-A
- Keywords
- risk reduction
- Medical subject headings
- Postoperative Complications, Infections, Ankle Injuries, Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSP-AOther
Also called Gold Standard Programme
6-week Gold Standard Programme (5 meetings in total) consisting a structured education programme, hotline, thiamine and B-vitamins (300 mg daily), Alcohol Withdrawal Prophylaxis and intervention (Benzodiazepines)and controlled Disulfiram support (200 mg x 2 weekly)
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Treatment as usual |
| GSP-A | Experimental | Gold-Standard-Program for Alcohol cessation intervention (GSP-A): 6-week intensive patient education program with pharmaceutical support Receives: Other: GSP-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Complications
A composite outcome including postoperative infections, second surgery, dislocated fracture, mal-union and other complications requiring treatment (neurological, pneumonia, thrombosis etc.)
Measured: 6 weeks + 3,6,9 and 12 months
Secondary outcomes (2)
Alcohol Intake
Continuous Alcohol Abstinence: 6 weeks Alcohol Abstinence and low-risk drinking: 3,6,9 and 12 months
Measured: 6 weeks + 3,6,9 and 12 months
Cost-Effectiveness
Cost-Effectiveness regarding postoperative complications and alcohol intake Cost-Utility regarding quality of life
Measured: 6 weeks + 3,6,9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startMay 2010
- Primary completion1 Jan 2016
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Fracture SurgeryStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, Hvidovre University Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, National Board of Health, Denmark, Karolinska Institutet
- Responsible party
- Principal investigator, Hanne Tonnesen, Bispebjerg Hospital
- Investigators
- Hanne Tønnesen, Professor, Principal investigator, WHO-CC, Bispebjerg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986791
- Sponsor's protocol ID
- Scand-Ankle
- Status last verified
- Mar 2018
- First submitted
- 29 Sep 2009
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tonnesen H, Egholm JW, Oppedal K, Lauritzen JB, Madsen BL, Pedersen B. Patient education for alcohol cessation intervention at the time of acute fracture surgery: study protocol for a randomised clinical multi-centre trial on a gold standard programme (Scand-Ankle). BMC Surg. 2015 May 1;15:52. doi: 10.1186/s12893-015-0035-z.
PubMed 25925742
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scand-Ankle: A Gold Standard Programme for Alcohol Cessation Intervention in Patients Undergoing Acute Fracture Surgery - A Randomised Clinical Multi-centre Study
- ClinicalTrials.gov ID
- NCT00986791
- Acronym / sponsor ID
- Scand-Ankle
- Conditions
- Acute Fracture Surgery, Alcohol Cessation Intervention, Postoperative Complications, Infection, Ankle Injuries
- Keywords
- risk reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- Lund University, Hvidovre University Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, National Board of Health, Denmark, Karolinska Institutet
- Study start
- May 2010 (actual)
- Primary completion
- 1 Jan 2016 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 30 Sep 2009 (estimated)
- 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.
Hazardous alcohol intake is an independent risk factor for postoperative complications after major and minor operations, elective and emergency procedures for men and women.
The aim of this study is to evaluate the effect of a 6-week Gold Standard Programme for alcohol cessation intervention in the perioperative period compared to the daily routine guidelines for patients with hazardous alcohol intake undergoing ankle fracture surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Treatment as usual |
| GSP-A | Experimental | Other: GSP-AGold-Standard-Program for Alcohol cessation intervention (GSP-A): 6-week intensive patient education program with pharmaceutical support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Drinking 21 or more drinks(one drink containing 12 g ethanol) per week for at least 3 months
- Traumatic ankle fracture requiring internal fixation (osteosynthesis; more than just Kirschner threads or similar minor intervention)
- Informed consent
- Randomisation within 36 hours after entering the orthopaedic department
Key exclusion criteria (9 listed)
- Major trauma involving other fractures or major lesions,
- Preoperative severe psychiatric disorders (including medicine addiction, severe alcohol dependence [defined as experience of delirium or seizures during abstinence from alcohol], dementia) or other conditions of reduced ability for giving informed consent
- Pathological fractures
- Pregnancy and lactation
- Allergy to benzodiazepines, anaesthesia, pain treatment or disulfiram
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 |
|---|---|---|
| GSP-AAlso: Gold Standard Programme6-week Gold Standard Programme (5 meetings in total) consisting a structured education programme, hotline, thiamine and B-vitamins (300 mg daily), Alcohol Withdrawal Prophylaxis and intervention (Benzodiazepines)and controlled Disulfiram support (200 mg x 2 weekly) | Other | GSP-A |
Primary outcome
Postoperative Complications
Time frame: 6 weeks + 3,6,9 and 12 months
A composite outcome including postoperative infections, second surgery, dislocated fracture, mal-union and other complications requiring treatment (neurological, pneumonia, thrombosis etc.)
2 secondary outcomes
Alcohol Intake
Time frame: 6 weeks + 3,6,9 and 12 months
Cost-Effectiveness
Time frame: 6 weeks + 3,6,9 and 12 months
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 30 Mar 2018.
- Results publication: PubMed 25925742Tonnesen H, Egholm JW, Oppedal K, Lauritzen JB, Madsen BL, Pedersen B. Patient education for alcohol cessation intervention at the time of acute fracture surgery: study protocol for a randomised clinical multi-centre trial on a gold standard programme (Scand-Ankle). BMC Surg. 2015 May 1;15:52. doi: 10.1186/s12893-015-0035-z.
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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.
Hanne Tønnesen, Professor principal investigator
WHO-CC, Bispebjerg University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GSP-A in people with Acute Fracture Surgery and Alcohol Cessation Intervention, run by Bispebjerg Hospital at 3 sites in Denmark.
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 4 inclusion and 9 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 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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?
Postoperative Complications (time frame: 6 weeks + 3,6,9 and 12 months). 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 NCT00986791, 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 30 Mar 2018.