Trials / Completed
CompletedNCT02562586
Is Drainage Necessary After Total Hip Replacement?
Is Drainage Necessary After Total Hip Replacement? A Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 92 (actual)
- Sponsor
- University of Sao Paulo · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this study was to compare early results of Total Hip Replacement (THR) in 2 groups of patients: with and without closed suction drainage (CSD). Patients were followed for 3 months post operatively.
Detailed description
After approval from the local ethical committee, patients undergoing Total Hip Replacement (THR) were included in this study. Patients with previous hip surgeries and coagulation disorders were not included. All patients were submitted to a non-cemented Total Hip Replacement (THR) through a Hardinge's approach. Before wound closure, a nurse opened an envelope containing the patient randomization: group 1 - with closed suction drainage (CSD) and group 2 - without closed suction drainage (CSD). In the group 1, a sub-fascial suction drain was used, and kept for 24 hours. Data collected included: mid-tigh circumference after 24 hours, blood transfusion, inflammatory blood markers C-Reactive Protein (CRP), Erythrocyte sedimentation rate (ESR) and leucogram, Harris Hip Score (HHS) after 3 months, and complications. Patients were followed for 3 months post operatively.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Closed Suction Drainage System | patients undergoing total hip replacement have received a closed suction drainage for 24 hours after the surgical procedure |
Timeline
- Start date
- 2014-05-01
- Primary completion
- 2015-05-01
- Completion
- 2015-08-01
- First posted
- 2015-09-29
- Last updated
- 2015-09-29
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT02562586. Inclusion in this directory is not an endorsement.