NCT03789266

Brief Summary

Comparison of ablation technique of drains

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 24, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 28, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2023

Completed
Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

4.7 years

First QC Date

July 24, 2018

Last Update Submit

February 4, 2026

Conditions

Total Hip ArthroplastyDrain Insertion Site

Outcome Measures

Primary Outcomes (1)

  • Evaluate the pain felt by the patients at the time of the removal of the drain, using the pain visual analogue scale

    pain will be measured using a visual analogic scale from 0 (for no pain) to 10 (fo maximum pain)

    20 minutes

Secondary Outcomes (1)

  • Presence of haematoma after ablation

    Day 2 post ablation

Study Arms (2)

Drain ablation - Non Aspiration mode

EXPERIMENTAL

Drain ablation will be done in non Aspiration mode

Procedure: drain ablation

Drain ablation - Aspiration mode

OTHER

Drain ablation will be done in Aspiration mode

Procedure: drain ablation

Interventions

drain ablationPROCEDURE

drain ablation will be done in Aspiration mode or in non Aspiration mode

Drain ablation - Aspiration modeDrain ablation - Non Aspiration mode

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Drain in non-aspirating mode at the time of medical ablation prescription

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rouen University Hospital

Rouen, France

Location

Study Officials

  • Mylène BONNAIRE

    University Hospital, Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
patient will not know which technique will be used for drain ablation
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2018

First Posted

December 28, 2018

Study Start

June 19, 2018

Primary Completion

March 6, 2023

Study Completion

March 6, 2023

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)