Recovery TimeNCT00713596
Study Evaluating Benefit of Using Fibrin Glue in Septorhinoplasty
A study testing Fibrinogen, Septorhinoplasty and Taping after septorhinoplasty. in people with Recovery Time and Bruising, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the use of fibrin glue during nasal surgery leads to a shorter recovery period with less bruising and/or swelling. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Recovery Time, Bruising
- What is being tested?
- Fibrinogen, Septorhinoplasty and Taping after septorhinoplasty.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jan 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient over 18 years of age undergoing septorhinoplasty.
Who cannot join
- Any patient having more than one procedure performed during one anesthetic.(i.e.brow lift, face lift, blepharoplasty)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Fibrin Sealant During Septorhinoplasty: Short and Long Term Benefits
The purpose of this study is to determine whether the use of fibrin glue during nasal surgery leads to a shorter recovery period with less bruising and/or swelling.
Read the detailed description
Septorhinoplasty is a well established technique to correct nasal deformity. Drawbacks of this procedure include a significant recovery following surgery which may often require nasal taping and casting. Swelling and bruising in and around the surgical site may persist for months after the operation. At present, there is no standard regarding the length of time nasal tape and cast should be used following septorhinoplasty. It has never been proven that taping or casting is required - in surgeries that require minimal amounts of tissue handling, we may not use any tape or cast following the procedure. Homologous fibrin glue has been used for various cosmetic facial plastic procedures since the early 1980's. It has been shown to decrease bruising and swelling following surgery. This study is being undertaken to evaluate these benefits of using fibrin glue in nasal surgery.
- Conditions
- Recovery Time, Bruising
- Being tested
- Fibrinogen, Septorhinoplasty, Taping after septorhinoplasty., Cast applied to the nose after nasal surgery, Saline
- Keywords
- Nasal Surgery, Septorhinoplasty, fibrin glue, fibrinogen, Swelling, fibrin, tisseel
- Medical subject headings
- Contusions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibrinogenDrug
Also called Tisseel
One time application of 0.5 cc to 2.0 cc of fibrinogen following surgery.
SeptorhinoplastyProcedure or surgery
Septorhinoplasty to correct nasal deviation.
Taping after septorhinoplasty.Procedure or surgery
Simple taping over the nose following nasal surgery.
Cast applied to the nose after nasal surgeryProcedure or surgery
A molded cast will be placed on top of the nose following nasal surgery.
SalineOther
Approximately 0.5 cc to 2 cc normal saline will be applied after the operation before the nasal taping and casting.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | Septorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline. Receives: Procedure: Septorhinoplasty; Procedure: Taping after septorhinoplasty.; Procedure: Cast applied to the nose after nasal surgery; Other: Saline |
| Fibrinogen, tape, and cast | Experimental | Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week. Receives: Drug: Fibrinogen; Procedure: Septorhinoplasty; Procedure: Taping after septorhinoplasty.; Procedure: Cast applied to the nose after nasal surgery |
| Fibrinogen and tape | Experimental | Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure. Receives: Drug: Fibrinogen; Procedure: Septorhinoplasty; Procedure: Taping after septorhinoplasty. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Assessments of Disease-specific Quality of Life, Nasal Symptoms, and Nasal Form at 6 Months as Measured by Rhinoplasty Outcomes Evaluation (ROE), Nasal Obstructive Symptoms Evaluate Scale (NOSE), and Global Measure of Nose Deformity
ROE: 6 items for subject's opinion re: nasal appearance, each item on 0-4 scale. Total score sum of 6 items, dividing total by 24 X 100, core ranges from 0 (least satisfied) to 100 (most satisfied).
NOSE: Assess five conditions over the past month, each item on 0-4 scale X 5, then summed. Total score ranges from 0 (no problem) to 100 (severe problem).
Global measure of nose deformity: Pictures of 4 indices of nasal anatomy: length, width, tip, and hump. Each index cored from 1-7, with 1=ideal nose, and 7=deformed nose. Total score = sum of 4 indices, range 4-28, lower score=more ideal nose
Measured: 6 months post operative
Secondary outcomes (1)
Assessment of the Results of Surgery 6 Months Post Operative by Review of Post Operative Photographs by the Operating Surgeon and 3 Blinded Reviewers Using a Mayo Clinic Surgeon Septorhinoplasty Questionnaire
At the end of the study standard post operative rhinoplasty photos will be obtained, and the photos will be reviewed by three blinded observers, who are experienced rhinoplasty surgeons. The photos will be presented to the evaluators in a completely random fashion at a single session. These photos will be graded at that time using the same questionnaire used by the operating surgeon. The questionnaire covers bruising, swelling, tenderness, and length, width, hump and tip of nose, with a range 4-40, 4=ideal nose to 40=many postoperative problems and disfigured nose.
Measured: 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: Lead investigator moved to a new medical center; study was stopped when he left.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recovery TimeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oren Friedman, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00713596
- Sponsor's protocol ID
- 06-009614
- Status last verified
- Mar 2016
- First submitted
- 9 Jul 2008
- Last updated
- 18 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Fibrin Sealant During Septorhinoplasty: Short and Long Term Benefits
- ClinicalTrials.gov ID
- NCT00713596
- Acronym / sponsor ID
- 06-009614
- Conditions
- Recovery Time, Bruising
- Keywords
- Nasal Surgery, Septorhinoplasty, fibrin glue, fibrinogen, Swelling, fibrin, tisseel
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lead investigator moved to a new medical center; study was stopped when he left.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 11 Jul 2008 (estimated)
- Results
- Posted 24 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the use of fibrin glue during nasal surgery leads to a shorter recovery period with less bruising and/or swelling.
Detailed description
Septorhinoplasty is a well established technique to correct nasal deformity. Drawbacks of this procedure include a significant recovery following surgery which may often require nasal taping and casting. Swelling and bruising in and around the surgical site may persist for months after the operation. At present, there is no standard regarding the length of time nasal tape and cast should be used following septorhinoplasty. It has never been proven that taping or casting is required - in surgeries that require minimal amounts of tissue handling, we may not use any tape or cast following the procedure. Homologous fibrin glue has been used for various cosmetic facial plastic procedures since the early 1980's. It has been shown to decrease bruising and swelling following surgery. This study is being undertaken to evaluate these benefits of using fibrin glue in nasal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Procedure: Septorhinoplasty, Procedure: Taping after septorhinoplasty., Procedure: Cast applied to the nose after nasal surgery, Other: SalineSeptorhinoplasty with postoperative application of nasal taping and an external nasal cast. The tape and cast will be left in place for one week. No tissue glue will be used during the operation, although the nurse and surgical assistant will simulate the preparation and insertion of tissue glue using a syringe containing saline. |
| Fibrinogen, tape, and cast | Experimental | Drug: Fibrinogen, Procedure: Septorhinoplasty, Procedure: Taping after septorhinoplasty., Procedure: Cast applied to the nose after nasal surgerySeptorhinoplasty will be performed. At the termination of the procedure, prior to closure, fibrin sealant will be applied by the surgical assistant to the surgical site. Approximately 0.5 cc to 2 cc of tissue sealant will be applied. After closure, tape and cast will be applied and left in place for one week. |
| Fibrinogen and tape | Experimental | Drug: Fibrinogen, Procedure: Septorhinoplasty, Procedure: Taping after septorhinoplasty.Septorhinoplasty will be performed. At the termination of the procedure, prior to closure, 0.5 cc to 2 cc of tissue sealant will be applied. Nasal tape will be applied after closure. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient over 18 years of age undergoing septorhinoplasty.
Key exclusion criteria (1 listed)
- Any patient having more than one procedure performed during one anesthetic.(i.e.brow lift, face lift, blepharoplasty)
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 |
|---|---|---|
| FibrinogenAlso: TisseelOne time application of 0.5 cc to 2.0 cc of fibrinogen following surgery. | Drug | Fibrinogen and tape, Fibrinogen, tape, and cast |
| SeptorhinoplastySeptorhinoplasty to correct nasal deviation. | Procedure or surgery | Control group, Fibrinogen and tape, Fibrinogen, tape, and cast |
| Taping after septorhinoplasty.Simple taping over the nose following nasal surgery. | Procedure or surgery | Control group, Fibrinogen and tape, Fibrinogen, tape, and cast |
| Cast applied to the nose after nasal surgeryA molded cast will be placed on top of the nose following nasal surgery. | Procedure or surgery | Control group, Fibrinogen, tape, and cast |
| SalineApproximately 0.5 cc to 2 cc normal saline will be applied after the operation before the nasal taping and casting. | Other | Control group |
Primary outcome
Patient Assessments of Disease-specific Quality of Life, Nasal Symptoms, and Nasal Form at 6 Months as Measured by Rhinoplasty Outcomes Evaluation (ROE), Nasal Obstructive Symptoms Evaluate Scale (NOSE), and Global Measure of Nose Deformity
Time frame: 6 months post operative
ROE: 6 items for subject's opinion re: nasal appearance, each item on 0-4 scale. Total score sum of 6 items, dividing total by 24 X 100, core ranges from 0 (least satisfied) to 100 (most satisfied). NOSE: Assess five conditions over the past month, each item on 0-4 scale X 5, then summed. Total score ranges from 0 (no problem) to 100 (severe problem). Global measure of nose deformity: Pictures of 4 indices of nasal anatomy: length, width, tip, and hump. Each index cored from 1-7, with 1=ideal nose, and 7=deformed nose. Total score = sum of 4 indices, range 4-28, lower score=more ideal nose
1 secondary outcome
Assessment of the Results of Surgery 6 Months Post Operative by Review of Post Operative Photographs by the Operating Surgeon and 3 Blinded Reviewers Using a Mayo Clinic Surgeon Septorhinoplasty Questionnaire
Time frame: 6 months postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Oren Friedman, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibrinogen, Septorhinoplasty and Taping after septorhinoplasty. in people with Recovery Time and Bruising, run by Mayo Clinic at 1 site in United States.
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 1 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: stopped early, as of the sponsor's last update on 18 Apr 2016. 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 United States. 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?
Yes. Results are posted in the registry (first posted 24 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Patient Assessments of Disease-specific Quality of Life, Nasal Symptoms, and Nasal Form at 6 Months as Measured by Rhinoplasty Outcomes Evaluation (ROE), Nasal Obstructive Symptoms Evaluate Scale (NOSE), and Global Measure of Nose Deformity (time frame: 6 months post operative). 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 18 Apr 2016.