Post-operative wound infection & breast cancer oncological outcomes.
Research type
Research Study
Full title
PAUS2: Long term follow-up of patients in PAUS study-randomised controlled trial of antibiotics vs no antibiotics in women undergoing surgery for breast cancer.
IRAS ID
247519
Contact name
Laszlo Romics
Contact email
Sponsor organisation
University of Glasgow
Duration of Study in the UK
1 years, 5 months, 31 days
Research summary
This study aims to identify whether there is an association between the presence of a postoperative wound infection and cancer recurrence and/or survival in patients with primary operable breast cancer. There is evidence that acute inflammation may stimulate residual cancer cells leading to early disease recurrence. This question is therefore important because, if an association between postoperative wound infection (ie. an extra inflammatory insult above that of the surgery itself) and poorer cancer outcomes is demonstrated, these patients would be identified as at higher risk of recurrence and therefore more aggressive additional (adjuvant) treatment regimen could be planned for them. It would also direct further research towards identifying ways of reducing rates of postoperative wound infection in breast cancer patients.
A cohort of patients who were originally recruited between 2003 and 2005 in the West of Scotland for participation in the Prophylactic Antibiotic Use in Breast Surgery (PAUS) trial exists with systematically and robustly collected data regarding patient and tumour characteristics, operative details and 30 day follow up data including presence or absence of a wound infection and any organisms cultured. From the original trial forms, the patient initials and date of birth will be used to find the patient on the regional electronic clinical record to collect follow up data regarding presence and timing of tumour recurrence, and survival status including cause and date of death. Where this latter is not available on the electronic record, an application to ISD will be completed. This new follow up data will be pseudonymised and linked to the original trial data using the patient’s study number. Statistical analysis will then be carried out to identify any significant association between presence of a post-operative wound infection and breast cancer recurrence or breast cancer-related death.
REC name
West of Scotland REC 4
REC reference
24/WS/0047
Date of REC Opinion
31 May 2024
REC opinion
Further Information Favourable Opinion