NCT02845427

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

January 22, 2019

Status Verified

February 1, 2017

Enrollment Period

1.5 years

First QC Date

July 14, 2016

Last Update Submit

January 17, 2019

Conditions

Total Hip Arthroplasty

Keywords

Closed Suction DrainWound Hematoma

Outcome Measures

Primary Outcomes (1)

  • change in Hb level

    preoperative and 24 hrs postoperative

Secondary Outcomes (2)

  • amount of blood loss

    upto 24 hrs postoperative

  • amount of blood transfusion

    upto 24 hrs postoperative

Study Arms (2)

A(drain group)

ACTIVE COMPARATOR

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

Device: closed suction drain

B(No drain group)

PLACEBO COMPARATOR

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

Procedure: no suction drain

Interventions

closed suction drainDEVICE

using closed suction drain system postoperative

A(drain group)
no suction drainPROCEDURE

the surgical wound will be closed with no suction drain

B(No drain group)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary total hip arthroplasty (THA)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Asyut, 71111, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor doctor of orthopedic and traumatology

Study Record Dates

First Submitted

July 14, 2016

First Posted

July 27, 2016

Study Start

February 1, 2016

Primary Completion

August 1, 2017

Study Completion

January 1, 2018

Last Updated

January 22, 2019

Record last verified: 2017-02

Locations

EG(1)