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Alcohol Cessation Intervention in an Acute Surgical Setting

Information source: Bispebjerg Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Fracture Surgery; Alcohol Cessation Intervention; Postoperative Complications; Infection; Ankle Injuries

Intervention: Gold Standard Programme for Alcohol Cessation Intervention (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Bispebjerg Hospital

Official(s) and/or principal investigator(s):
Hanne Tønnesen, Professor, Principal Investigator, Affiliation: WHO-CC, Bispebjerg University Hospital

Overall contact:
Hanne Tønnesen, Professor, Email: hanne.tonnesen@regionh.dk

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 period compared to the daily routine guidelines for patients with hazardous alcohol intake undergoing ankle fracture surgery.

Clinical Details

Official title: Scand-Ankle: A Gold Standard Programme for Alcohol Cessation Intervention in Patients Undergoing Acute Fracture Surgery - A Randomised Clinical Multi-centre Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Postoperative Complications

Secondary outcome:

Alcohol Intake

Cost-Effectiveness

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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)

- ASA score 4-5

- Canceled operation

- Withdrawal of informed consent

Locations and Contacts

Hanne Tønnesen, Professor, Email: hanne.tonnesen@regionh.dk

Hospital Of South West Denmark, Aabenraa, Denmark; Recruiting
Helle Staulund, Study Nurse, Email: hsstaulund@privat.dk
Christian Akim Jacobsen, MD, Principal Investigator

Bispebjerg University Hospital, Copenhagen, Denmark; Recruiting
Julie Weber, MD, Email: jegh0006@regionh.dk
Jes Bruun Lauritzen, Professor, Principal Investigator

Hvidovre University Hospital, Hvidovre, Copenhagen 2650, Denmark; Recruiting
Ina Stark, Study Nurse, Email: Ina.Hjortkjaer.Stark@regionh.dk
Bjørn Lindegaard Madsen, MD, Principal Investigator

Additional Information

Starting date: November 2009
Last updated: April 14, 2014

Page last updated: August 20, 2015

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