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Effectiveness of Using Closed-suction Drainage in Treating Proximal Femur Fracture With Cephalomedullary Nail

NCT04229212 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-01-18

No results posted yet for this study

Summary

Introduction: The closed suction drainage system is widely used in proximal femur surgeries. Recently, the proximal femoral nail antirotation (PFNA) system was advocated for treating intertrochanteric fractures (ITFs) in the elderly patients. However, the true effect of the closed suction drainage system with PFNA fixation on outcomes in ITFs is still unknown. This prospective randomized controlled trial aimed to examine whether routine drainage is useful for PFNA fixation in ITFs.

Methods: A total of 80 patients with acute ITFs were treated with closed or mini-open reduction with PFNA fixation at the National Cheng Kung University Hospital and 60 eligible patients (22 men and 38 women) were randomized for whether to receive suction drainage. In clinical outcomes, the visual analog scale (VAS), morphine equivalent dosage, injured thigh width, body temperature, and wound condition with specific reference to hematoma formation and wound infection were measured on postoperative days 1, 2, 4, and 10. In laboratory outcomes, the investigators evaluated hemoglobin and hematocrit levels postoperatively at different time points. Blood transfusion and total blood loss (TBL) were measured by Mercuriali's formula in millimeter.

Conditions

  • Intertrochanteric Fractures

Interventions

DEVICE

hemovac drain (Zimmer Biomet, Autotransfusion System [HAS], United State)

In the drained group, a hemovac drain (Zimmer Biomet, Autotransfusion System \[HAS\], United State) was placed beneath the fascia of the gluteus muscle, surrounding the entry point of the nail at the fracture site.

Sponsors & Collaborators

  • National Cheng-Kung University Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-11
Primary Completion
2019-12-31
Completion
2019-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04229212 on ClinicalTrials.gov