Closed Suction Drain or Not After Total Hip Arthroplasty

Total Hip Arthroplasty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02845427
• Other study ID #: AUHOR1
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: January 1, 2018

Study information

• Verified date: February 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 1, 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Total Hip Arthroplasty

Intervention

Device:
• closed suction drain
using closed suction drain system postoperative

Procedure:
• no suction drain
the surgical wound will be closed with no suction drain

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in Hb level		preoperative and 24 hrs postoperative
Secondary	amount of blood loss		upto 24 hrs postoperative
Secondary	amount of blood transfusion		upto 24 hrs postoperative