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Intra-operative Nasal Compression After Lateral Osteotomy to Minimize Post-operative Peri-orbital Ecchymosis and Edema

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ClinicalTrials.gov Identifier: NCT02319954
Recruitment Status : Completed
First Posted : December 18, 2014
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Lawson Health Research Institute

Brief Summary:
Periorbital edema and ecchymosis are common morbidities in the post-operative period after rhinoplasty. Lateral osteotomy techniques used to reshape the bony nasal pyramid are large contributing factors to the degree of bruising and edema. This is due to injury to the angular vessels that are crossing the osteotomy sites. Depending on the degree of swelling and bruising, it can cause difficulty with visual acuity in the early post-operative period. Most importantly, this can be quite distressing to the patient and impact the time required to return to normal social activities. Numerous studies have examined various interventions to reduce periorbital swelling and ecchymosis. These include peri-operative steroids, lidocaine with epinephrine injections, fibrin sealant, permissive intra-operative hypotension and subperiosteal osteotomy techniques. Peri-operative steroids have been most extensively studied. Recent meta-analysis by Hatef et al, found that pre-operative steroids were effective for decreasing post-operative edema and ecchymosis. Steroids however, carry with it the risks of psychosis, immunosuppression, weight gain, uncontrolled blood glucose and avascular necrosis of the hip. As such, broadly applicable and cost-effective techniques to minimize post-operative edema and ecchymosis without the risk profile of steroids would be ideal. Taskin et al. recently examined the efficacy of the combination of intraoperative cold saline-soaked gauze compression and corticosteroids on rhinoplasty morbidity. The study group received compression with a cold saline soaked gauze to the nasal dorsum during the surgery and the control group received compression with a dry gauze. Both groups received a pre-operative dose of intravenous steroids. The study group had significantly less periorbital edema and ecchymosis on post-operative days 1, 3, 5 and 7. This study unfortunately did not examine the role of compression alone and the study was performed in the presence of steroids, which is not routinely utilized by all surgeons. As such, the proposed study will provide evidence for the use of direct compression intra-operatively after lateral osteotomy in order to reduce post-operative edema and ecchymosis. The findings of this study may provide a simple, effective and non-costly technique to minimize the morbidity of rhinoplasty.

Condition or disease Intervention/treatment Phase
Rhinoplasty Ecchymosis Procedure: Direct compression Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Intra-operative Nasal Compression After Lateral Osteotomy to Minimize Post-operative Peri-orbital Ecchymosis and Edema
Actual Study Start Date : January 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Active Comparator: Compression
Each patient will be randomized to receive compression of their nose on either the left or right for 5 continuous minutes after performing a lateral rhinotomy.
Procedure: Direct compression
Direct compression by the surgeon with their hands on the nasal sidewall

No Intervention: No compression
Each patient will serve as their own control with the other side not receiving any compression after a lateral rhinotomy.



Primary Outcome Measures :
  1. Periorbital edema and ecchymosis [ Time Frame: up to 4 weeks ]
    The primary outcome of this study is periorbital edema and ecchymosis. Post-operative photographs will be graded by two staff Otolaryngologists and two senior Otolaryngology residents. Each evaluator will be presented a photograph of a patient and be asked to grade the degree of periorbital edema and ecchymosis for the left and right side. Previously published grading scales will be used. The evaluators will be blinded to the allocated side of nasal pressure and to the post-operative day of the photographs.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All adult patients (18 years old and greater) undergoing rhinoplasty requiring lateral osteotomy

Exclusion Criteria:

  • Patients taking anti-coagulation medication, history of bleeding disorder and those who do not complete the follow-up schedule will be excluded from the study.

Publications:

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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT02319954    
Other Study ID Numbers: HSREB 105768
First Posted: December 18, 2014    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ecchymosis
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms