The effectiveness of peri-operative use of human surgical sealant (Quixil) in reducing the post-operative seroma formation in breast cancer patients

ISRCTN	ISRCTN35333172
DOI	https://doi.org/10.1186/ISRCTN35333172
Protocol serial number	N0523136364
Sponsor	Department of Health
Funder	Good Hope Hospital NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Mr T Vijayganesh
Scientific

Good Hope Hospital
Sutton Coldfield
Birmingham
B75 7RR
United Kingdom

Email	abc@email.com

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	The effectiveness of peri-operative use of human surgical sealant (Quixil) in reducing the post-operative seroma formation in breast cancer patients
Study objectives	The trial proposes to establish the usefulness of 'Quixil' in reducing the incidence of post-operative seroma in breast cancer operations
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cancer: Breast
Intervention	1. Quixil 2. No Quixil
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Reduction in seroma formation of more than 30%
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/12/2004

Participant type(s)	Patient
Age group	Not Specified
Sex	Female
Target sample size at registration	100
Key inclusion criteria	100 patients undergoing mastectomy or wide local excision with axillary clearance for biopsy proven breast cancer. 50 to each arm.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/08/2003
Date of final enrolment	01/12/2004

Good Hope Hospital

Birmingham
B75 7RR
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan