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SSI Rates in Patients Undergoing Mastectomy Without Reconstruction- A Multicenter, Double-blinded RCT.

NCT04577846 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2020-10-08

No results posted yet for this study

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.

Conditions

  • Surgical Site Infection

Interventions

DRUG

Cephalexin 500 MG

Cefalexin 500 mg PO q8 hours will be continued for the duration of the indwelling drains which usually is about 14 days.

DRUG

Placebo

A placebo capsule filled with inert material for the duration of the drains which usually is about 14 days.

Sponsors & Collaborators

  • Liaquat National Hospital & Medical College

    collaborator OTHER

  • Dow University of Health Sciences

    collaborator OTHER

  • Aga Khan University

    lead OTHER

Principal Investigators

  • Abida K. Sattar, MD, FACS · Aga Khan University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Pakistan

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04577846 on ClinicalTrials.gov