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Drains Ablation Post Total Hip Arthroplasty : Search for the Least Painful Technique (TADDA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03789266
Recruitment Status : Recruiting
First Posted : December 28, 2018
Last Update Posted : December 28, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Brief Summary:
Comparison of ablation technique of drains

Condition or disease Intervention/treatment Phase
Total Hip Arthroplasty Drain Insertion Site Procedure: drain ablation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: patient will not know which technique will be used for drain ablation
Primary Purpose: Supportive Care
Official Title: Drains Ablation Post Total Hip Arthroplasty : Search for the Least Painful Technique
Actual Study Start Date : June 19, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: Drain ablation - Non Aspiration mode
Drain ablation will be done in non Aspiration mode
Procedure: drain ablation
drain ablation will be done in Aspiration mode or in non Aspiration mode

Drain ablation - Aspiration mode
Drain ablation will be done in Aspiration mode
Procedure: drain ablation
drain ablation will be done in Aspiration mode or in non Aspiration mode




Primary Outcome Measures :
  1. Evaluate the pain felt by the patients at the time of the removal of the drain, using the pain visual analogue scale [ Time Frame: 20 minutes ]
    pain will be measured using a visual analogic scale from 0 (for no pain) to 10 (fo maximum pain)


Secondary Outcome Measures :
  1. Presence of haematoma after ablation [ Time Frame: Day 2 post ablation ]
    Presence or absence of haematoma will be visually checked



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients admitted to the orthopedic surgery department for surgery for a total hip arthroplasty
  2. Signed inform consent form

Exclusion Criteria:

  1. Drain in non-aspirating mode at the time of medical ablation prescription
  2. Administration of analgesic III in the 12 hours preceding the inclusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789266


Contacts
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Contact: Mylène BONNAIRE, Ms +3323288 ext 8265 mylene.bonnaire@chu-rouen.Fr
Contact: Julien BLOT +3323288 ext 8265 julien.blot@chu-rouen.fr

Locations
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France
Rouen University Hospital Recruiting
Rouen, France
Contact: Mylène BONNAIRE         
Sponsors and Collaborators
University Hospital, Rouen
Investigators
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Principal Investigator: Mylène BONNAIRE Rouen University Hospital

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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT03789266    
Other Study ID Numbers: 2016/382/HP
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: December 28, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No