Closed Suction Drain or Not After Total Hip Arthroplasty

Study Overview
=================
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.

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

Conditions
-----------------
Total Hip Arthroplasty

Intervention / Treatment
-----------------
* Device: closed suction drain
* Procedure: no suction drain


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Closed Suction Drain, Wound Hematoma