SSI Rates in Patients Undergoing Mastectomy Without Reconstruction- A Multicenter, Double-blinded RCT.
Status:
Not yet recruiting
Trial end date:
2022-12-31
Target enrollment:
Participant gender:
Summary
Breast cancer is the second most prevalent malignancy in the world and an important component
of treatment warrants surgical procedures such as mastectomy. Surgical site infections after
breast surgery may range from 1-26%, which is high for surgeries that are considered "clean
procedures", as defined by the Centers for Disease Control and Prevention (CDC) wound
classification system.
Prophylactic antibiotics given before the surgical incision as per Joint Commissions SCIP
(Surgical Care Improvement Project) guidelines, have been shown to decrease the rate of
postoperative infections in a vast number of patients. There is however, no clear consensus
due to lack of evidence on continuation (duration) of prophylactic antibiotics in patients
undergoing mastectomy with indwelling drains, and thus antibiotic prescribing practices may
vary among breast as well as reconstructive surgeons.
In this trial all patients undergoing mastectomy without immediate reconstruction will
receive a single prophylactic dose of preoperative antibiotic, and subsequently, the patients
will be randomized to either continue the prophylactic antibiotics or receive a placebo for
the duration of indwelling drains. The aim of this trial is to compare the difference in SSI
rates between these two study arms as the main outcome. In addition, the factors associated
with differing rates of SSI in the intervention and control group will also be identified.
Phase:
Phase 3
Details
Lead Sponsor:
Aga Khan University
Collaborators:
Dow University of Health Sciences Liaquat National Hospital & Medical College