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Completed

NCT Number: NCT02845427

Closed Suction Drain or Not After Total Hip Arthroplasty

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).

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Key information

Conditions

Total Hip Arthroplasty

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine

Asyut, 71111, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

closed suction drain

Device

using closed suction drain system postoperative

no suction drain

Procedure

the surgical wound will be closed with no suction drain

Primary outcomes

  1. change in Hb level

    Time frame: preoperative and 24 hrs postoperative

Secondary outcomes

  1. amount of blood loss

    Time frame: upto 24 hrs postoperative

  2. amount of blood transfusion

    Time frame: upto 24 hrs postoperative

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jul 27, 2016
Registry last updated
Jan 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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