Closed Suction Drain or Not After Total Hip Arthroplasty

Closed Suction Drain or Not After Total Hip Arthroplasty: A Randomized Controlled Trial

Comparative randomised study to clarify which better to use or no use of closed suction drain system after total hip arthroplasty regarding amount of blood loss, need for blood transfusion, risk for superficial infection, ecchymosis, wound discharge, effect on early post-operative rehabilitation. Patients will be followed up for one month postoperative clinically (Harris Hip score system), laboratory (Hb level), and radiologically (A-P view plain x-ray of the hip).

Study Overview

• Status: Completed
• Conditions: Total Hip Arthroplasty
• Intervention / Treatment: Device: closed suction drain; Procedure: no suction drain

Detailed Description

Total Hip Arthroplasty (THA) wounds are prone to formation of hematomas. Hematomas may increase the incision tension, leading to wound discharge and providing a good medium for bacteria, increase post-operative pain, limitation of range of motion of hip joint and prolong post-operative rehabilitation duration, also may cause ecchymosis, and tension vesicles around the surgical wound.

So use of closed suction drain system may reduce these complications. Nevertheless some recent studies have claimed that drainage can cause other complications and does not reduce hematoma formation and risk for infection. Furthermore, some studies have shown that drainage increase blood loss after THA which may both lead to increase blood transfusion requirements and provide an entry point for skin microorganisms.

Some other studies have found that no significance between use and non use of suction drain after THA.

So the investigators will take this issue for study a comparison between benefits and hazards of use and non use of suction drain after THA.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Primary total hip arthroplasty (THA)

Exclusion Criteria:

• Revision cases
• Uncontrolled bleeding tendency (prothrombin conc. Less than 70%)
• History of deep venous thrombosis
• Sever liver impairment (liver failure)
• Sever renal impairment (S. creatinine more than 3)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A(drain group); patients of primary THA will have closed suction drain introduced intraoperative at surgical site	Device: closed suction drain; using closed suction drain system postoperative
Placebo Comparator: B(No drain group); patients of primary THA will have the surgical wound be closed with no suction drain	Procedure: no suction drain; the surgical wound will be closed with no suction drain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change in Hb level	preoperative and 24 hrs postoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
amount of blood loss	upto 24 hrs postoperative
amount of blood transfusion	upto 24 hrs postoperative

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: July 14, 2016
• First Submitted That Met QC Criteria: July 23, 2016
• First Posted (Estimate): July 27, 2016

Study Record Updates

• Last Update Posted (Actual): January 22, 2019
• Last Update Submitted That Met QC Criteria: January 17, 2019
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Closed Suction Drain; Wound Hematoma
• Other Study ID Numbers: AUHOR1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided