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

October 6, 2020 updated by: Abida K. Sattar, MD, FACS, Aga Khan University

Surgical Site Infection (SSI) Rates in Patients Undergoing Mastectomy Without Reconstruction, a Comparison Among Those Receiving Preoperative Prophylactic Antibiotics Alone Versus Continued Prophylactic Antibiotics Postoperatively-A Multicenter, Double-blinded Randomized Control Trial.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Introduction:

Worldwide, breast cancer comprises 10.4% of all cancer among women, making it the second most common cancer (after lung cancer) and the fifth most common cause of cancer related death. The management of patients as a matter of patient preference or as dictated by extent of disease often warrants a mastectomy.

Reports of surgical site infections after breast surgery including mastectomy may range from 1-26%, which is high for surgeries that are considered "clean procedures". Despite a high rate of surgical site infections, there is no consensus on the continuation/duration of prophylactic antibiotics in patients undergoing mastectomy. Consequently, practices may vary among breast and reconstructive surgeons. Evidence regarding the risk of SSI with the use and duration of indwelling drains is also controversial. The length of prolonged, postoperative antibiotic may also vary by practitioners, some using a pre-defined regimen of about 2-7 days, and others continuing them until the drains are removed.

Most guidelines recommend a single dose of pre-operative antibiotics and continuation after surgery has been discouraged. The use of common or more specific antibiotics for the duration of drains being in place is also controversial. The recommendation by recent national clinical guidelines is to use one dose of pre-procedural antibiotics for mastectomy patients with or without drains. The American Society of Breast Surgeons also does not recommend the continuation of post-surgical antibiotics in the absence of relevant indications. However, practices vary.

Rationale:

Since there is lack of evidence and significant surgeon practice variation despite guidelines developed by leading societies, we propose to study the difference in rates of surgical site infection (SSI) with or without continuation of prolonged post-operative, prophylactic antibiotics in all patients undergoing mastectomy without immediate reconstruction and with indwelling drains.

Aim:

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.

Significance:

Through this study, the investigators will be able to identify the most effective prophylactic regimen to reduce rates of SSI among mastectomy patients with indwelling drains leading to evidence-based and informed decision making.

Primary Objective:

To determine rates of surgical site infection (SSI) in patients in two separate arms of this trial, in which all patients will receive the first prophylactic pre/perioperative antibiotic dose and then be randomized to:

  1. Post-operative antibiotic prophylaxis continued for the duration of indwelling drains
  2. Those who only receive a single dose of preoperative prophylactic antibiotic.

Secondary Objective:

To identify factors associated with differing rates of SSI in the intervention and control group

Primary Outcome:

Surgical site infection(SSI) rates at the mastectomy wound site or the drain(s) insertion site among patients. In this study SSI will be evaluated using the standard CDC criteria which are as follows:

  1. purulent drainage from the incision or drain site;
  2. organisms isolated from an aseptically obtained culture of fluid or tissue;
  3. deliberate opening of the incision by a surgeon in patients having either tenderness, localized swelling, redness, or warmth; or
  4. diagnosis of SSI by the surgeon or study wound assessor (trained research assistant) or
  5. prescription of therapeutic antibiotics;
  6. Patients clinically diagnosed and documented to have cellulitis.

Study Type

Interventional

Enrollment (Anticipated)

384

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74200
        • Dow University of Health Sciences
      • Karachi, Sindh, Pakistan, 7480 0
        • Aga Khan University Hospital
      • Karachi, Sindh, Pakistan, 74800
        • Liaquat National Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria: Patients who will undergo mastectomy (without immediate reconstruction) at AKUH, LNH, and DUHS (with or without axillary surgery), who will have indwelling closed suction drain(s) postoperatively and will give consent to participate in the study

Exclusion Criteria:

  • Undergo breast reconstruction
  • Who have other medical indications for which they must remain on antibiotics for more than the single preoperative dose
  • Those with any history of allergies to beta-lactam drug
  • Patients who had an open breast or axillary biopsy/breast conservation in the last 30 days on the ipsilateral side.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Intervention Arm
The intervention arm will be administered, either Cefazolin iv every 8 hours while NPO or cefalexin 500 mg q8 hours per oral if tolerating a diet.
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.
PLACEBO_COMPARATOR: Control
Controls will be provided with initially IV placebo while NPO and then with a placebo capsule filled with inert material for the duration of the 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Site Infection (SSI)
Time Frame: up to 30 days.

Standard CDC criteria:

  1. purulent drainage from the incision or drain site;
  2. organisms isolated from an aseptically obtained culture of fluid or tissue;
  3. deliberate opening of the incision by a surgeon in patients having either tenderness, localized swelling, redness, or warmth; or
  4. diagnosis of SSI by the surgeon or study wound assessor or
  5. prescription of therapeutic antibiotics;
  6. Patients clinically diagnosed and documented to have cellulitis.
up to 30 days.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of antibiotic associated side-effects
Time Frame: will be assessed during the follow-up visits between postoperative days 4-8 days for the 1st postoperative visit and subsequently at each routine postoperative visit while the drain is in place, for a maximum of 30 days.
infections/diarrhea/other side effects
will be assessed during the follow-up visits between postoperative days 4-8 days for the 1st postoperative visit and subsequently at each routine postoperative visit while the drain is in place, for a maximum of 30 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aga Khan University

Collaborators

Dow University of Health Sciences
Liaquat National Hospital & Medical College

Investigators

  • Principal Investigator: Abida K. Sattar, MD, FACS, Aga Khan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 1, 2020

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

October 1, 2020

First Submitted That Met QC Criteria

October 6, 2020

First Posted (ACTUAL)

October 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-3627-1407

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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