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

NCT04229212 | Completed

• 1 other identifier: B-BR-107-046-T
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Intertrochanteric Fractures; Proximal Femoral Nail Antirotation (PFNA); closed suction drainage system

Outcome Measures

Primary Outcomes (10)

• Blood transfusion

  mL

  preoperation

• Blood transfusion

  mL

  postoperative days 1

• Blood transfusion

  mL

  postoperative days 2

• Blood transfusion

  mL

  postoperative days 4

• Blood transfusion

  mL

  postoperative days 10

• Total blood loss (TBL)

  Mercuriali's formula: TBL = blood volume (BV) × (Hct \[preop\] - Hct \[POD 4\] + transfused RBC \[mL\])

  Pre-operation

• Total blood loss (TBL)

  Mercuriali's formula: TBL = blood volume (BV) × (Hct \[preop\] - Hct \[POD 4\] + transfused RBC \[mL\])

  postoperative days 1

• Total blood loss (TBL)

  Mercuriali's formula: TBL = blood volume (BV) × (Hct \[preop\] - Hct \[POD 4\] + transfused RBC \[mL\])

  postoperative days 2

• Total blood loss (TBL)

  Mercuriali's formula: TBL = blood volume (BV) × (Hct \[preop\] - Hct \[POD 4\] + transfused RBC \[mL\])

  postoperative days 4

• Blood transfusion and total blood loss (TBL)

  Mercuriali's formula: TBL = blood volume (BV) × (Hct \[preop\] - Hct \[POD 4\] + transfused RBC \[mL\])

  postoperative days 10

Secondary Outcomes (15)

• body temperature

  preoperative

• body temperature

  postoperative days 1

• body temperature

  postoperative days 2

• body temperature

  postoperative days 4

• Secondary outcome-Pain

  postoperative days 1

Study Arms (2)

No drainage

NO INTERVENTION

No drainage

Drainage

EXPERIMENTAL

a hemovac drain (Zimmer Biomet, Autotransfusion System \[HAS\], United State) was placed

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

Interventions

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

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.

Drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• had an acute (injury less than 2 weeks) proximal femoral fracture, classified as Arbeitsgemeinschaft für Osteosynthesefragen (AO) 31A1, 31A2, and 31A314,
• were treated with closed reduction or mini-open reduction, and
• were followed-up for at least 2 weeks post-surgery.

You may not qualify if:

• a history of muscular-skeletal disorder or inflammatory arthritis,
• other combined injury,
• a previous hip surgery,
• an extensive open reduction of fracture site,
• hemodynamic instability,
• consumed non-steroid inflammatory drug, steroid, or morphine before treatment, and (7) abnormal preoperative laboratory data, especially anticoagulation data, including prothrombin time, activated partial thromboplastin time (aPTT), and platelet level.

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

Related Publications (3)

• Varley GW, Milner SA. Wound drains in proximal femoral fracture surgery: a randomized prospective trial of 177 patients. J R Coll Surg Edinb. 1995 Dec;40(6):416-8.

  PMID: 8583450 RESULT

• Tjeenk RM, Peeters MP, van den Ende E, Kastelein GW, Breslau PJ. Wound drainage versus non-drainage for proximal femoral fractures. A prospective randomised study. Injury. 2005 Jan;36(1):100-4. doi: 10.1016/j.injury.2004.04.011.

  PMID: 15589927 RESULT

• Zhou XD, Wu LD. Reply to Comment on Zhou et al.: Do we really need closed-suction drainage in total hip arthroplasty? A meta-analysis. Int Orthop. 2013 Dec;37(12):2531-2. doi: 10.1007/s00264-013-2125-9. Epub 2013 Oct 11. No abstract available.

  PMID: 24114245 RESULT

MeSH Terms

Conditions

Hip Fractures

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: One independent observer who was not involved with the treatment performed the clinical assessments and laboratory data collection during the preoperative and intraoperative periods and on postoperative days 1, 2, and 4 (during admission) and on postoperative day 10 for suture removal.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This single center study was performed between May 2018 and April 2019. All the 60 patients who were treated with a PFNA system (Depuy Synthes®, Proximal Femoral Nail Antirotation (II), Solothurn, Switzerland) were consecutively included. The investigators established a table of random numbers, which was readily generated by computer 15, and divided participants into the drained and undrained groups based on their arrival time to our hospital.

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 18, 2020
• Study Start: December 11, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Locations

TW (1)