Closed Suction Drain or Not After Total Hip Arthroplasty

Not Applicable

Completed

• Conditions: Total Hip Arthroplasty
• Interventions: Device: closed suction drain; Procedure: no suction drain

• Registration Number: NCT02845427
• Lead Sponsor: Assiut University

Brief Summary

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).

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 Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-07-14
• Study First Submitted QC: 2016-07-23
• Study First Posted: 2016-07-27
• Status Verified: 2017-02
• Primary Completion: 2017-08
• Study Completion: 2018-01-01
• Last Update Submitted: 2019-01-17
• Last Update Posted: 2019-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A(drain group)	closed suction drain	patients of primary THA will have closed suction drain introduced intraoperative at surgical site
B(No drain group)	no suction drain	patients of primary THA will have the surgical wound be closed with no suction drain

Primary Outcome Measures

Name	Time	Method
change in Hb level	preoperative and 24 hrs postoperative

Secondary Outcome Measures

Name	Time	Method
amount of blood loss	upto 24 hrs postoperative
amount of blood transfusion	upto 24 hrs postoperative

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇬 Assiut, Egypt