Postoperative EcchymosisPhase 2NCT01982760
DDAVP in the Reduction of Post-operative Ecchymosis in Rhinoplasty
A Phase 2 study testing DDAVP in people with Postoperative Ecchymosis, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
This is study looking at the use of a medication, Desmopressin acetate (DDAVP), to reduce bleeding, swelling, and bruising in patients undergoing cosmetic nose surgery. DDAVP is a drug used in patients with bleeding disorders. It works by activating molecules in the blood stream called platelets that promote clotting. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Ecchymosis
- What is being tested?
- DDAVP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to 25 Jun 2015
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing Rhinoplasty where nasal bone osteotomy is necessary
Who cannot join
- Heart Disease
- Renal Disease with decreased GFR
- Liver Disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Trial for the Use of DDAVP in the Reduction of Post-operative Ecchymosis in Rhinoplasty.
This is study looking at the use of a medication, Desmopressin acetate (DDAVP), to reduce bleeding, swelling, and bruising in patients undergoing cosmetic nose surgery. DDAVP is a drug used in patients with bleeding disorders. It works by activating molecules in the blood stream called platelets that promote clotting. In the study, participants who are have cosmetic nose surgery (rhinoplasty) will be randomly assigned to receive or not receive medication. Photographs taken before and shortly after surgery will be evaluated for the amount of bruising and swelling. Patients with heart, lung, kidney, or liver problems are not eligible to participate.
- Conditions
- Postoperative Ecchymosis
- Being tested
- DDAVP
- Keywords
- Rhinoplasty, Ecchymosis, Edema
- Medical subject headings
- Ecchymosis, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DDAVPDrug
Also called Desmopressin
Patients Receiving DDAVP prior to operation
| Study group | Role | What they receive |
|---|---|---|
| DDAVP | Experimental | Arm receiving DDAVP prior to the operation. Drug is administered intravenously at .3mcg per kg, over 30 minutes prior to the operation. Receives: Drug: DDAVP |
| No DDAVP | No intervention | Patients Will not receive DDAVP prior to Rhinoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Ecchymosis and Swelling
Photographs taken preoperatively at 1 day and 8 days post-operatively will be analyzed for bruising
Measured: surgery to 8 days post-operatively
Secondary outcomes (1)
Patient Behavior Factors
Looking at the time it takes for patients to feel comfortable wearing makeup, going out in public, and returning to work
Measured: Surgery to 3 weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2013 (estimated)
- Study startDec 2013
- Primary completion25 Jun 2015
- Study completion25 Jun 2015
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 Postoperative EcchymosisStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bahman Guyuron, MD, Principal investigator, University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01982760
- Sponsor's protocol ID
- 07-10-21
- Status last verified
- Jul 2023
- First submitted
- 5 Nov 2013
- Last updated
- 16 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial for the Use of DDAVP in the Reduction of Post-operative Ecchymosis in Rhinoplasty.
- ClinicalTrials.gov ID
- NCT01982760
- Acronym / sponsor ID
- 07-10-21
- Conditions
- Postoperative Ecchymosis
- Keywords
- Rhinoplasty, Ecchymosis, Edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- Dec 2013 (actual)
- Primary completion
- 25 Jun 2015 (actual)
- Study completion
- 25 Jun 2015 (actual)
- First posted
- 13 Nov 2013 (estimated)
- Results
- Posted 16 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is study looking at the use of a medication, Desmopressin acetate (DDAVP), to reduce bleeding, swelling, and bruising in patients undergoing cosmetic nose surgery. DDAVP is a drug used in patients with bleeding disorders. It works by activating molecules in the blood stream called platelets that promote clotting. In the study, participants who are have cosmetic nose surgery (rhinoplasty) will be randomly assigned to receive or not receive medication. Photographs taken before and shortly after surgery will be evaluated for the amount of bruising and swelling. Patients with heart, lung, kidney, or liver problems are not eligible to participate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DDAVP | Experimental | Drug: DDAVPArm receiving DDAVP prior to the operation. Drug is administered intravenously at .3mcg per kg, over 30 minutes prior to the operation. |
| No DDAVP | No intervention | –Patients Will not receive DDAVP prior to Rhinoplasty |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing Rhinoplasty where nasal bone osteotomy is necessary
Key exclusion criteria (3 listed)
- Heart Disease
- Renal Disease with decreased GFR
- Liver Disease
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 |
|---|---|---|
| DDAVPAlso: DesmopressinPatients Receiving DDAVP prior to operation | Drug | DDAVP |
Primary outcome
Reduction in Ecchymosis and Swelling
Time frame: surgery to 8 days post-operatively
Photographs taken preoperatively at 1 day and 8 days post-operatively will be analyzed for bruising
1 secondary outcome
Patient Behavior Factors
Time frame: Surgery to 3 weeks post-operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Patient Satisfaction and Recovery Outcomes Associated With Perioperative ELIXIR MD Use
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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.
Bahman Guyuron, MD principal investigator
University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DDAVP in people with Postoperative Ecchymosis, run by University Hospitals Cleveland Medical Center 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 3 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 16 Aug 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Aug 2023). 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?
Reduction in Ecchymosis and Swelling (time frame: surgery to 8 days post-operatively). 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 16 Aug 2023.