Total Hip ArthroplastyNCT02845427
Closed Suction Drain or Not After Total Hip Arthroplasty
A study testing closed suction drain and no suction drain in people with Total Hip Arthroplasty, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Hip Arthroplasty
- What is being tested?
- closed suction drain and no suction drain
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2016to 1 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary total hip arthroplasty (THA)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Closed Suction Drain or Not After Total Hip Arthroplasty: A Randomized Controlled Trial
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).
Read the 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
- Being tested
- closed suction drain, no suction drain
- Keywords
- Closed Suction Drain, Wound Hematoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closed suction drainDevice
using closed suction drain system postoperative
no suction drainProcedure or surgery
the surgical wound will be closed with no suction drain
| Study group | Role | What they receive |
|---|---|---|
| A(drain group) | Active comparator | patients of primary THA will have closed suction drain introduced intraoperative at surgical site Receives: 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 Receives: Procedure: no suction drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Hb level
Measured: preoperative and 24 hrs postoperative
Secondary outcomes (2)
amount of blood loss
Measured: upto 24 hrs postoperative
amount of blood transfusion
Measured: upto 24 hrs postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study startFeb 2016
- Primary completionAug 2017
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasser E khalifa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02845427
- Sponsor's protocol ID
- AUHOR1
- Status last verified
- Feb 2017
- First submitted
- 14 Jul 2016
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed Suction Drain or Not After Total Hip Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02845427
- Acronym / sponsor ID
- AUHOR1
- Conditions
- Total Hip Arthroplasty
- Keywords
- Closed Suction Drain, Wound Hematoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Aug 2017 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 27 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A(drain group) | Active comparator | Device: closed suction drainpatients of primary THA will have closed suction drain introduced intraoperative at surgical site |
| B(No drain group) | Placebo comparator | Procedure: no suction drainpatients of primary THA will have the surgical wound be closed with no suction drain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary total hip arthroplasty (THA)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| closed suction drainusing closed suction drain system postoperative | Device | A(drain group) |
| no suction drainthe surgical wound will be closed with no suction drain | Procedure or surgery | B(No drain group) |
Primary outcome
change in Hb level
Time frame: preoperative and 24 hrs postoperative
2 secondary outcomes
amount of blood loss
Time frame: upto 24 hrs postoperative
amount of blood transfusion
Time frame: upto 24 hrs postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Individual participant dataSharing planned: Undecided
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Developmental Dysplasia of the Hip, Acetabular Bone Loss
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Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty: A Randomized Controlled Trial
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Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing closed suction drain and no suction drain in people with Total Hip Arthroplasty, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Hb level (time frame: preoperative and 24 hrs postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2019.