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

Primary Purpose

Rhinoplasty, Ecchymosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Direct compression
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rhinoplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Compression

    No compression

    Arm Description

    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.

    Each patient will serve as their own control with the other side not receiving any compression after a lateral rhinotomy.

    Outcomes

    Primary Outcome Measures

    Periorbital edema and ecchymosis
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 14, 2014
    Last Updated
    November 2, 2018
    Sponsor
    Lawson Health Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02319954
    Brief Title
    Intra-operative Nasal Compression After Lateral Osteotomy to Minimize Post-operative Peri-orbital Ecchymosis and Edema
    Official Title
    Intra-operative Nasal Compression After Lateral Osteotomy to Minimize Post-operative Peri-orbital Ecchymosis and Edema
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2015 (Actual)
    Primary Completion Date
    June 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Lawson Health Research Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rhinoplasty, Ecchymosis

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    16 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Compression
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    No compression
    Arm Type
    No Intervention
    Arm Description
    Each patient will serve as their own control with the other side not receiving any compression after a lateral rhinotomy.
    Intervention Type
    Procedure
    Intervention Name(s)
    Direct compression
    Intervention Description
    Direct compression by the surgeon with their hands on the nasal sidewall
    Primary Outcome Measure Information:
    Title
    Periorbital edema and ecchymosis
    Description
    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.
    Time Frame
    up to 4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21493314
    Citation
    Taskin U, Yigit O, Bilici S, Kuvat SV, Sisman AS, Celebi S. Efficacy of the combination of intraoperative cold saline-soaked gauze compression and corticosteroids on rhinoplasty morbidity. Otolaryngol Head Neck Surg. 2011 May;144(5):698-702. doi: 10.1177/0194599811400377.
    Results Reference
    background
    PubMed Identifier
    22795164
    Citation
    Tuncel U, Turan A, Bayraktar MA, Erkorkmaz U, Kostakoglu N. Efficacy of dexamethasone with controlled hypotension on intraoperative bleeding, postoperative oedema and ecchymosis in rhinoplasty. J Craniomaxillofac Surg. 2013 Mar;41(2):124-8. doi: 10.1016/j.jcms.2012.06.003. Epub 2012 Jul 12.
    Results Reference
    background
    PubMed Identifier
    17572575
    Citation
    Totonchi A, Guyuron B. A randomized, controlled comparison between arnica and steroids in the management of postrhinoplasty ecchymosis and edema. Plast Reconstr Surg. 2007 Jul;120(1):271-274. doi: 10.1097/01.prs.0000264397.80585.bd.
    Results Reference
    background
    PubMed Identifier
    21813878
    Citation
    Hatef DA, Ellsworth WA, Allen JN, Bullocks JM, Hollier LH Jr, Stal S. Perioperative steroids for minimizing edema and ecchymosis after rhinoplasty: a meta-analysis. Aesthet Surg J. 2011 Aug;31(6):648-57. doi: 10.1177/1090820X11416110.
    Results Reference
    background
    PubMed Identifier
    21458231
    Citation
    Gun R, Yorgancilar E, Yildirim M, Bakir S, Topcu I, Akkus Z. Effects of lidocaine and adrenaline combination on postoperative edema and ecchymosis in rhinoplasty. Int J Oral Maxillofac Surg. 2011 Jul;40(7):722-9. doi: 10.1016/j.ijom.2011.02.022. Epub 2011 Apr 1.
    Results Reference
    background
    PubMed Identifier
    24531244
    Citation
    Kosucu M, Omur S, Besir A, Uraloglu M, Topbas M, Livaoglu M. Effects of perioperative remifentanil with controlled hypotension on intraoperative bleeding and postoperative edema and ecchymosis in open rhinoplasty. J Craniofac Surg. 2014 Mar;25(2):471-5. doi: 10.1097/SCS.0000000000000603.
    Results Reference
    background
    PubMed Identifier
    18838319
    Citation
    Al-Arfaj A, Al-Qattan M, Al-Harethy S, Al-Zahrani K. Effect of periosteum elevation on periorbital ecchymosis in rhinoplasty. J Plast Reconstr Aesthet Surg. 2009 Nov;62(11):e538-9. doi: 10.1016/j.bjps.2008.05.047. Epub 2008 Oct 5. No abstract available.
    Results Reference
    background
    PubMed Identifier
    16094573
    Citation
    Kara CO, Kara IG, Topuz B. Does creating a subperiosteal tunnel influence the periorbital edema and ecchymosis in rhinoplasty? J Oral Maxillofac Surg. 2005 Aug;63(8):1088-90. doi: 10.1016/j.joms.2005.04.008.
    Results Reference
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    Intra-operative Nasal Compression After Lateral Osteotomy to Minimize Post-operative Peri-orbital Ecchymosis and Edema

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