Closed Suction Drain or Not After Total Hip Arthroplasty

NCT ID: NCT02845427

Last Updated: 2019-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-01-01

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.

Conditions

Total Hip Arthroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A(drain group)

patients of primary THA will have closed suction drain introduced intraoperative at surgical site

Group Type: ACTIVE_COMPARATOR

closed suction drain

Intervention Type: DEVICE

using closed suction drain system postoperative

B(No drain group)

patients of primary THA will have the surgical wound be closed with no suction drain

Group Type: PLACEBO_COMPARATOR

no suction drain

Intervention Type: PROCEDURE

the surgical wound will be closed with no suction drain

Interventions

closed suction drain

using closed suction drain system postoperative

Intervention Type: DEVICE

no suction drain

the surgical wound will be closed with no suction drain

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Yasser E khalifa

professor doctor of orthopedic and traumatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine

Asyut, , Egypt

Countries

Egypt

Other Identifiers

AUHOR1

Identifier Type: -

Identifier Source: org_study_id