Is Drainage Necessary After Total Hip Replacement?

University of Sao Paulo

Status: Completed

Conditions: Osteoarthritis, Hip

Treatments: Device: Closed Suction Drainage System

Study type: Interventional

Funder types: Other

Identifiers

NCT02562586

CEP 1055

Details and patient eligibility

About

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.

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary Hip Arthroplasty
• Lateral Hardinge Approach
• Non-cemented Acetabular and Femoral Components
• Length of Skin Incision between 10 and 20 cm

Exclusion criteria

• Coagulative Disorders
• Previous Surgery in the same limb
• Age below 18 years old

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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92 participants in 2 patient groups

Closed Suction Drainage System

Active Comparator group

Description:

Group 1: patients undergoing total hip replacement received a Closed Suction Drainage System for 24 hours after the surgical procedure

Treatment:

Device: Closed Suction Drainage System

No Closed Suction Drainage System

No Intervention group

Description:

Group 2: patients undergoing total hip replacement have not received a Closed Suction Drainage System after the surgical procedure