<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04507412</url>
  </required_header>
  <id_info>
    <org_study_id>ORL-ORT- 020</org_study_id>
    <nct_id>NCT04507412</nct_id>
  </id_info>
  <brief_title>Intravenous Dexamethasone Administration in Patients Undergoing Total Shoulder Arthroplasty</brief_title>
  <official_title>Effect of Perioperative Intravenous Dexamethasone Administration in Patients Undergoing Total Shoulder Arthroplasty for Osteoarthritis, in Terms of Post-operative Pain, Function, Nausea, Hospitalization Length, and Risk of Complications</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Christian Candrian</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ente Ospedaliero Cantonale, Bellinzona</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to evaluate if intravenous steroid supplementation can provide&#xD;
      advantages over routine analgesia protocols in terms of post-operative symptoms (pain and&#xD;
      nausea), length of hospital stay, shoulder range of motion, function and patient satisfaction&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to detect the efficacy of intravenous perioperative steroid&#xD;
      supplementation for total shoulder arthroplasty (TSA) surgeries in terms of short-term and&#xD;
      long-term clinical outcomes and to demonstrate its advantages over the routine anaesthesia&#xD;
      protocol. The comparison will be evaluated in terms of post- operative pain and function,&#xD;
      opioids and analgesic drugs consumption, patient satisfaction, patient reported outcome&#xD;
      measures (validated clinical scores), clinician-assessed clinical scores, systemic&#xD;
      inflammatory response, length of hospital stay and long-term outcomes. Moreover, to confirm&#xD;
      the safety of steroid supplementation all treatment related adverse events- and reactions are&#xD;
      going to be recorded and reported, as well as post-operative glycaemia will be monitored.&#xD;
&#xD;
      The primary objective of the study is to show the efficacy on post-operative pain of&#xD;
      intravenous perioperative dexamethasone supplementation for TSA.&#xD;
&#xD;
      The secondary objectives of the study are to show superiority by comparison of the&#xD;
      intravenous peri- operative dexamethasone supplementation group to the routine analgesia&#xD;
      protocol (no steroid supplementation group), in terms of post-operative pain and function,&#xD;
      patient satisfaction, shoulder active- and passive range of motion, quantification with&#xD;
      validated clinician- and patient reported outcome measures as the Constant, ASES and SSV&#xD;
      Scores for function and EQ-5D-3L Score for health-related quality of life, opioids and&#xD;
      analgesic drugs consumption, systemic inflammatory response, time until first mobilization&#xD;
      and until the patient first slept through at night, the length of hospital stay and presence&#xD;
      or absence of a frozen shoulder at the postoperative follow-up, as well as adverse events and&#xD;
      reactions, in order to document the advantage over the absence of steroid supplementation in&#xD;
      the short-, mid- term- and long-term follow up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 9, 2020</start_date>
  <completion_date type="Anticipated">August 31, 2032</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2024</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This study is a 2-arm randomized controlled trial comparing i.v. dexamethasone supplementation (arm-A) and no steroid supplementation (arm-B) for total shoulder arthroplasty</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The present study will be double blinded: both participants and assessors will be blinded to the assigned treatment. Surgeons will be also blinded, only anaesthetists taking part to surgery will be aware of the group to which the patient was assigned but they will not take part to the follow-up visits.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>mean post-operative daily pain at rest</measure>
    <time_frame>first 3 days after surgery</time_frame>
    <description>0-10 numeric rating scale (NRS)from 0 to 10, with 10 being most painful</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-operative shoulder pain</measure>
    <time_frame>first 3 months after surgery</time_frame>
    <description>0-10 numeric rating scale (NRS)from 0 to 10, with 10 being most painful</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative shoulder pain</measure>
    <time_frame>2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery</time_frame>
    <description>0-10 numeric rating scale (NRS)from 0 to 10, with 10 being most painful</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative global shoulder function score</measure>
    <time_frame>daily during the first 3 months</time_frame>
    <description>0-10 numeric rating scale (NRS)from 0 to 10, with 10 being most functional</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative global shoulder function score</measure>
    <time_frame>2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery</time_frame>
    <description>0-10 numeric rating scale (NRS)from 0 to 10, with 10 being most functional</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The clinician assessed Constant score</measure>
    <time_frame>2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery</time_frame>
    <description>The Constant Score questionnaire consists of 8 questions (giving a score of 0 -100, with 100 being the best score) evaluating pain, activity level and range of motion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES Score)</measure>
    <time_frame>2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery</time_frame>
    <description>The ASES Score is a patient reported outcome measure (PROM), a validated score evaluating pain and function for daily living and leisure activity. A maximum of 100 points means maximum (normal) functionality and no pain. MCID is 13.6 ± 2.3 points after total shoulder prosthesis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Subjective Shoulder Value (SSV)</measure>
    <time_frame>2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery</time_frame>
    <description>The SSV is a percent of the subjective value of the shoulder given from the patient from 0-100%.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>European Quality of Life-5 Dimensions-3 Level</measure>
    <time_frame>2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery</time_frame>
    <description>&quot;Health-Related Quality-of-Life Score&quot; and is preferred evaluating cost utility analysis and changes in general health after surgical operations. It contains 5 questions and the maximum (best) score is 1. MCID is 0.07 units</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PainDETECT</measure>
    <time_frame>2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery</time_frame>
    <description>PainDETECT consists of seven questions that address the quality of pain symptoms; it is completed by the patient and no physical examination is required. A score ≤12 indicates that pain is unlikely to have a neuropathic component (&lt; 15%), while a score of ≥19 suggests that pain is likely to have a neuropathic component (&gt; 90%). An intermediate score (≥13, ≤18) indicates a possible neuropathic component.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery</time_frame>
    <description>0-10 numeric rating scale (NRS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative nausea</measure>
    <time_frame>first 3 days post-operative days during hospitalisation</time_frame>
    <description>incidence and intensity (on a 0-10 NRS) will be evaluated. The 0-10 NRS is a valid and reliable instrument used for the self- assessment of symptoms: it consists in a single 11-point numeric scale, with 0 indicating no nausea and 10 reflecting the worst possible nausea</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative opioids and analgesic drugs consumption</measure>
    <time_frame>first 3 days post-operative days during hospitalisation</time_frame>
    <description>Medication Quantification Scale (MQS) score. It is calculated for each medication by taking a consensus-based detriment weight for a given pharmacologic class and multiplying it by a score for dosage. The calculated values for each medication are then summed for a total MQS score. The score can provide a useful point measure of medication usage for any pain medication regime</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative inflammatory response</measure>
    <time_frame>preoperatively and first 3 days post-operative days during hospitalisation</time_frame>
    <description>This outcome will be evaluated in terms of hematic C-Reactive Protein (CRP) and erythrocyte sedimentation rate (ESR) (the medical chart will be evaluated)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from surgery to first mobilization</measure>
    <time_frame>During Hospitalization, approximately 1 days</time_frame>
    <description>Time from surgery to first mobilization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of frozen shoulders</measure>
    <time_frame>1 week post-operative during hospitalisation</time_frame>
    <description>This is considered a complication occurring up to 11% and is induced by postoperative inflammatory processes that can lead to adhesive capsulitis</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Rate of serious adverse events related to steroid supplementation</measure>
    <time_frame>2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery</time_frame>
    <description>Rate of serious adverse events related to steroid supplementation</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of prosthetic joint infections</measure>
    <time_frame>2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery</time_frame>
    <description>Rate of prosthetic joint infections</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of wound infections</measure>
    <time_frame>2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery</time_frame>
    <description>Rate of wound infections</description>
  </other_outcome>
  <other_outcome>
    <measure>Rate of wound healing problems</measure>
    <time_frame>2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery</time_frame>
    <description>Rate of wound healing problems</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">74</enrollment>
  <condition>Arthroplasty, Replacement, Shoulder</condition>
  <arm_group>
    <arm_group_label>arm A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>• 9 mg of i.v. dexamethasone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>arm B</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>• no steroid supplementation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dexamethasone</intervention_name>
    <description>perioperatively 9 mg i.v subministration</description>
    <arm_group_label>arm A</arm_group_label>
    <other_name>Steroids</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing unilateral primary total anatomical or reverse shoulder&#xD;
             arthroplasty (Total Shoulder Arthroplasty)&#xD;
&#xD;
          -  Patients with a BMI &gt;18.5 and &lt;35&#xD;
&#xD;
          -  Patients able to provide informed consent and follow all the study procedures as&#xD;
             indicated by the protocol&#xD;
&#xD;
          -  Informed Consent as documented by signature&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications to steroids&#xD;
&#xD;
          -  Revision and post-traumatic TSA&#xD;
&#xD;
          -  Active steroid or immunosuppressive therapy in the last 30 days before the operation&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#xD;
&#xD;
          -  Presence of other clinically significant concomitant disease states (ASA IV)&#xD;
&#xD;
          -  Uncontrolled diabetes mellitus&#xD;
&#xD;
          -  Contraindications to Non-steroidal anti-inflammatory drugs&#xD;
&#xD;
          -  Chronic systemic diseases as immunodeficiency, autoimmune disease (Systemic Lupus&#xD;
             Erythematosus), gout, rheumatic arthritis&#xD;
&#xD;
          -  Known or suspected non-compliance, drug or alcohol abuse&#xD;
&#xD;
          -  Inability to follow the procedures of the study, e.g. due to language problems,&#xD;
             psychological disorders, dementia, etc. of the participant.&#xD;
&#xD;
          -  Participation in another study with investigational drug within the 30 days preceding&#xD;
             and during the present study&#xD;
&#xD;
          -  Previous enrolment into the current study&#xD;
&#xD;
          -  Enrolment of the investigator, his/her family members, employees and other dependent&#xD;
             persons&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>58 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian Candrian, Prof.Dr.med</last_name>
    <role>Principal Investigator</role>
    <affiliation>EOC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christian Candrian, Prof.Dr.med</last_name>
    <phone>+41 (0) 91 811 61 23</phone>
    <email>christian.candrian@eoc.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gyözö Lehoczky, Dr.med</last_name>
    <phone>+41918116431</phone>
    <email>Gyoezoe.Lehoczky@eoc.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Christian Candrian</name>
      <address>
        <city>Lugano</city>
        <zip>6900</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christian Candrian, Prof.Dr.med</last_name>
      <phone>+41 (0) 91 811 61 23</phone>
      <email>christian.candrian@eoc.ch</email>
    </contact>
    <contact_backup>
      <last_name>Gianluigi Capone, Dr.</last_name>
      <email>gianluigi.capone@eoc.ch</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>August 7, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2020</study_first_posted>
  <last_update_submitted>September 6, 2023</last_update_submitted>
  <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ente Ospedaliero Cantonale, Bellinzona</investigator_affiliation>
    <investigator_full_name>Christian Candrian</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Total Shoulder Arthroplasty</keyword>
  <keyword>steroid</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>not foreseen</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04507412
org study id: ORL-ORT- 020
nct id: NCT04507412
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The aim of the study is to evaluate if intravenous steroid supplementation can provide
      advantages over routine analgesia protocols in terms of post-operative symptoms (pain and
      nausea), length of hospital stay, shoulder range of motion, function and patient satisfaction
The purpose of this study is to detect the efficacy of intravenous perioperative steroid
      supplementation for total shoulder arthroplasty (TSA) surgeries in terms of short-term and
      long-term clinical outcomes and to demonstrate its advantages over the routine anaesthesia
      protocol. The comparison will be evaluated in terms of post- operative pain and function,
      opioids and analgesic drugs consumption, patient satisfaction, patient reported outcome
      measures (validated clinical scores), clinician-assessed clinical scores, systemic
      inflammatory response, length of hospital stay and long-term outcomes. Moreover, to confirm
      the safety of steroid supplementation all treatment related adverse events- and reactions are
      going to be recorded and reported, as well as post-operative glycaemia will be monitored.

      The primary objective of the study is to show the efficacy on post-operative pain of
      intravenous perioperative dexamethasone supplementation for TSA.

      The secondary objectives of the study are to show superiority by comparison of the
      intravenous peri- operative dexamethasone supplementation group to the routine analgesia
      protocol (no steroid supplementation group), in terms of post-operative pain and function,
      patient satisfaction, shoulder active- and passive range of motion, quantification with
      validated clinician- and patient reported outcome measures as the Constant, ASES and SSV
      Scores for function and EQ-5D-3L Score for health-related quality of life, opioids and
      analgesic drugs consumption, systemic inflammatory response, time until first mobilization
      and until the patient first slept through at night, the length of hospital stay and presence
      or absence of a frozen shoulder at the postoperative follow-up, as well as adverse events and
      reactions, in order to document the advantage over the absence of steroid supplementation in
      the short-, mid- term- and long-term follow up.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study is a 2-arm randomized controlled trial comparing i.v. dexamethasone supplementation (arm-A) and no steroid supplementation (arm-B) for total shoulder arthroplasty
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: The present study will be double blinded: both participants and assessors will be blinded to the assigned treatment. Surgeons will be also blinded, only anaesthetists taking part to surgery will be aware of the group to which the patient was assigned but they will not take part to the follow-up visits.
measure: mean post-operative daily pain at rest
time frame: first 3 days after surgery
description: 0-10 numeric rating scale (NRS)from 0 to 10, with 10 being most painful
measure: Post-operative shoulder pain
time frame: first 3 months after surgery
description: 0-10 numeric rating scale (NRS)from 0 to 10, with 10 being most painful
measure: Post-operative shoulder pain
time frame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
description: 0-10 numeric rating scale (NRS)from 0 to 10, with 10 being most painful
measure: Post-operative global shoulder function score
time frame: daily during the first 3 months
description: 0-10 numeric rating scale (NRS)from 0 to 10, with 10 being most functional
measure: Post-operative global shoulder function score
time frame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
description: 0-10 numeric rating scale (NRS)from 0 to 10, with 10 being most functional
measure: The clinician assessed Constant score
time frame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
description: The Constant Score questionnaire consists of 8 questions (giving a score of 0 -100, with 100 being the best score) evaluating pain, activity level and range of motion
measure: The American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES Score)
time frame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
description: The ASES Score is a patient reported outcome measure (PROM), a validated score evaluating pain and function for daily living and leisure activity. A maximum of 100 points means maximum (normal) functionality and no pain. MCID is 13.6 ± 2.3 points after total shoulder prosthesis
measure: The Subjective Shoulder Value (SSV)
time frame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
description: The SSV is a percent of the subjective value of the shoulder given from the patient from 0-100%.
measure: European Quality of Life-5 Dimensions-3 Level
time frame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
description: "Health-Related Quality-of-Life Score" and is preferred evaluating cost utility analysis and changes in general health after surgical operations. It contains 5 questions and the maximum (best) score is 1. MCID is 0.07 units
measure: PainDETECT
time frame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
description: PainDETECT consists of seven questions that address the quality of pain symptoms; it is completed by the patient and no physical examination is required. A score ≤12 indicates that pain is unlikely to have a neuropathic component (< 15%), while a score of ≥19 suggests that pain is likely to have a neuropathic component (> 90%). An intermediate score (≥13, ≤18) indicates a possible neuropathic component.
measure: Patient satisfaction
time frame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
description: 0-10 numeric rating scale (NRS)
measure: Post-operative nausea
time frame: first 3 days post-operative days during hospitalisation
description: incidence and intensity (on a 0-10 NRS) will be evaluated. The 0-10 NRS is a valid and reliable instrument used for the self- assessment of symptoms: it consists in a single 11-point numeric scale, with 0 indicating no nausea and 10 reflecting the worst possible nausea
measure: Post-operative opioids and analgesic drugs consumption
time frame: first 3 days post-operative days during hospitalisation
description: Medication Quantification Scale (MQS) score. It is calculated for each medication by taking a consensus-based detriment weight for a given pharmacologic class and multiplying it by a score for dosage. The calculated values for each medication are then summed for a total MQS score. The score can provide a useful point measure of medication usage for any pain medication regime
measure: Postoperative inflammatory response
time frame: preoperatively and first 3 days post-operative days during hospitalisation
description: This outcome will be evaluated in terms of hematic C-Reactive Protein (CRP) and erythrocyte sedimentation rate (ESR) (the medical chart will be evaluated)
measure: Time from surgery to first mobilization
time frame: During Hospitalization, approximately 1 days
description: Time from surgery to first mobilization
measure: Rate of frozen shoulders
time frame: 1 week post-operative during hospitalisation
description: This is considered a complication occurring up to 11% and is induced by postoperative inflammatory processes that can lead to adhesive capsulitis
measure: Rate of serious adverse events related to steroid supplementation
time frame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
description: Rate of serious adverse events related to steroid supplementation
measure: Rate of prosthetic joint infections
time frame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
description: Rate of prosthetic joint infections
measure: Rate of wound infections
time frame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
description: Rate of wound infections
measure: Rate of wound healing problems
time frame: 2 and 6 weeks after surgery and 3, 6, 12, 24, 60 ,120 months after surgery
description: Rate of wound healing problems
arm group label: arm A
arm group type: Experimental
description: • 9 mg of i.v. dexamethasone
arm group label: arm B
arm group type: No Intervention
description: • no steroid supplementation
intervention type: Drug
intervention name: dexamethasone
description: perioperatively 9 mg i.v subministration
arm group label: arm A
other name: Steroids
criteria: 
gender: All
minimum age: 58 Years
maximum age: 85 Years
healthy volunteers: No
last name: Christian Candrian, Prof.Dr.med
role: Principal Investigator
affiliation: EOC
last name: Christian Candrian, Prof.Dr.med
phone: +41 (0) 91 811 61 23
email: christian.candrian@eoc.ch
last name: Gyözö Lehoczky, Dr.med
phone: +41918116431
email: Gyoezoe.Lehoczky@eoc.ch
facility: 
status: Recruiting
contact: 
contact backup: 
country: Switzerland
responsible party type: Sponsor-Investigator
investigator affiliation: Ente Ospedaliero Cantonale, Bellinzona
investigator full name: Christian Candrian
investigator title: Principal Investigator
mesh term: Dexamethasone
sharing ipd: No
ipd description: not foreseen