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Trial Outcomes & Findings for DDAVP in the Reduction of Post-operative Ecchymosis in Rhinoplasty (NCT NCT01982760)

NCT ID: NCT01982760

Last Updated: 2023-08-16

Results Overview

Photographs taken preoperatively at 1 day and 8 days post-operatively will be analyzed for bruising

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

surgery to 8 days post-operatively

Results posted on

2023-08-16

Participant Flow

Participant milestones

Participant milestones
Measure
DDAVP
Arm receiving DDAVP prior to the operation. Drug is administered intravenously at .3mcg per kg, over 30 minutes prior to the operation. DDAVP: Patients Receiving DDAVP prior to operation
No DDAVP
Patients Will not receive DDAVP prior to Rhinoplasty
Overall Study
STARTED
14
0
Overall Study
COMPLETED
13
0
Overall Study
NOT COMPLETED
1
0

Reasons for withdrawal

Reasons for withdrawal
Measure
DDAVP
Arm receiving DDAVP prior to the operation. Drug is administered intravenously at .3mcg per kg, over 30 minutes prior to the operation. DDAVP: Patients Receiving DDAVP prior to operation
No DDAVP
Patients Will not receive DDAVP prior to Rhinoplasty
Overall Study
Physician Decision
1
0

Baseline Characteristics

DDAVP in the Reduction of Post-operative Ecchymosis in Rhinoplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
DDAVP
n=14 Participants
Arm receiving DDAVP prior to the operation. Drug is administered intravenously at .3mcg per kg, over 30 minutes prior to the operation. DDAVP: Patients Receiving DDAVP prior to operation
No DDAVP
Patients Will not receive DDAVP prior to Rhinoplasty
Total
n=14 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
14 Participants
n=99 Participants
0 Participants
n=107 Participants
14 Participants
n=206 Participants
Age, Categorical
>=65 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Sex: Female, Male
Female
9 Participants
n=99 Participants
0 Participants
n=107 Participants
9 Participants
n=206 Participants
Sex: Female, Male
Male
5 Participants
n=99 Participants
0 Participants
n=107 Participants
5 Participants
n=206 Participants

PRIMARY outcome

Timeframe: surgery to 8 days post-operatively

Population: No data collected

Photographs taken preoperatively at 1 day and 8 days post-operatively will be analyzed for bruising

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Surgery to 3 weeks post-operatively

Population: No data collected

Looking at the time it takes for patients to feel comfortable wearing makeup, going out in public, and returning to work

Outcome measures

Outcome data not reported

Adverse Events

DDAVP

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

No DDAVP

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Bahman Guyuron

Case School of Medicine

Phone: 440-461-7999

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place