Trial Outcomes & Findings for Influence of Fibrin Glue on Seroma Formation After Modified Radical Mastectomy (NCT NCT00909649)

Last Updated: 2009-05-28

Results Overview

the mean total drainage volume

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

within 30 days postoperative

Results posted on

2009-05-28

medical clinic

Withdrawal data not reported

Influence of Fibrin Glue on Seroma Formation After Modified Radical Mastectomy

Baseline characteristics by cohort
Measure	Fibrin Group n=25 Participants	Non Fibrin Group n=25 Participants	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0.0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	22 Participants n=7 Participants	44.0 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	3 Participants n=7 Participants	6.0 Participants n=5 Participants
Age Continuous	52.2 years STANDARD_DEVIATION 11.5 • n=5 Participants	51.6 years STANDARD_DEVIATION 10.8 • n=7 Participants	51.9 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	25 Participants n=7 Participants	50.0 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0.0 Participants n=5 Participants
Region of Enrollment Egypt	25 participants n=5 Participants	25 participants n=7 Participants	50.0 participants n=5 Participants

Timeframe: within 30 days postoperative

Population: ITT

the mean total drainage volume

Outcome measures
Measure	Fibrin Group n=25 Participants	Non Fibrin Group n=25 Participants
Seroma Formation	770.48 ml Standard Deviation 70.81	1089.51 ml Standard Deviation 75.8

Adverse event data not reported

Adverse event data not reported

Mansoura university hospital

Phone: 0106752021