Trial Outcomes & Findings for Study Evaluating Benefit of Using Fibrin Glue in Septorhinoplasty (NCT NCT00713596)

Results Overview

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

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

6 months post operative

Results posted on

2016-04-18

Participant Flow

Patients presenting for septorhinoplasty at the Mayo Clinic, Rochester, MN were offered the opportunity to participate in the study.

Participant milestones

Participant milestones
Measure	Control Group 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.	Fibrin Sealant Group, Tape and Cast 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.	Fibrin Sealant Group 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.
Overall Study STARTED	9	8	8
Overall Study COMPLETED	7	5	6
Overall Study NOT COMPLETED	2	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Group 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.	Fibrin Sealant Group, Tape and Cast 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.	Fibrin Sealant Group 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.
Overall Study Study was terminated	2	3	2

Baseline Characteristics

Study Evaluating Benefit of Using Fibrin Glue in Septorhinoplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=9 Participants 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.	Fibrin Sealant Group, Tape and Cast n=8 Participants 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.	Fibrin Sealant Group n=8 Participants 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.	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	25 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	10 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	15 Participants n=4 Participants
Region of Enrollment United States	9 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants	25 participants n=4 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months postoperative

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.

Outcome measures

Outcome data not reported

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fibrin Sealant Group, Tape and Cast

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Fibrin Sealant Group

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. Oren Friedman

Mayo Clinic

Phone: 507-538-1392

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place