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
Protocol serial number N0264132545
Sponsor Department of Health
Funder United Bristol Healthcare NHS Trust (UK)
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

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific titleProspective, 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 objectivesTo 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) studiedSurgery: Breast reconstruction
Intervention1. Quilting suture and drain
2. Drain only
Intervention typeProcedure/Surgery
Primary outcome measure(s)

Not provided at time of registration

Key secondary outcome measure(s)

Not provided at time of registration

Completion date01/08/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Key inclusion criteriaNot provided at time of registration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/08/2001
Date of final enrolment01/08/2004

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Level 1, The Old Building
Bristol
BS2 8HW
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot 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.