Prospective, randomised study comparing quilting and a drain with a drain only on the incidence of seroma formation in the back wound after Latissimus Dorsi breast reconstruction (LDBR)

ISRCTN	ISRCTN88578537
DOI	https://doi.org/10.1186/ISRCTN88578537
Secondary identifying numbers	N0264132545

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 28/02/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

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

Contact information

Dr M Schuijtvlot
Scientific

Level 1, The Old Building
Bristol Royal Infirmary
Malborough Street
Bristol
BS2 8HW
United Kingdom

Phone	+44 (0)117 928 3473
Email	abc@email.com

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Prospective, randomised study comparing quilting and a drain with a drain only on the incidence of seroma formation in the back wound after Latissimus Dorsi breast reconstruction (LDBR)
Study objectives	To do a prospective randomised comparison of the seronoma rate in the back wound between drain and quilting versus drains alone.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Breast reconstruction
Intervention	1. Quilting suture and drain 2. Drain only
Intervention type	Procedure/Surgery
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/08/2001
Completion date	01/08/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/08/2001
Date of final enrolment	01/08/2004

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Level 1, The Old Building

Bristol
BS2 8HW
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

United Bristol Healthcare NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

28/02/2020: No publications found. All search options exhausted.
27/02/2020: No publications found, verifying study status with principal investigator.