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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04577846
Recruitment Status : Not yet recruiting
First Posted : October 8, 2020
Last Update Posted : October 8, 2020
Sponsor:
Collaborators:
Liaquat National Hospital & Medical College
Dow University of Health Sciences
Information provided by (Responsible Party):
Abida K. Sattar, MD, FACS, Aga Khan University

Brief 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.


Condition or disease Intervention/treatment Phase
Surgical Site Infection Drug: Cephalexin 500 MG Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 384 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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.
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04577846


Contacts
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Contact: Abida K. Sattar, MD, FACS +92 345 8298088 aksattar@hotmail.com; abida.sattar@aku.edu

Locations
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Pakistan
Dow University of Health Sciences
Karachi, Sindh, Pakistan, 74200
Contact: Omema Saleem, MBBS    +923333739944    omema_dr@yahoo.com   
Sub-Investigator: Omema Saleem         
Aga Khan University Hospital
Karachi, Sindh, Pakistan, 7480 0
Contact: Abida K. Sattar, MD, FACS    +9221 34864751    abida.sattar@aku.edu   
Principal Investigator: Abida K. Sattar, MD, FACS         
Sub-Investigator: Nida Zahid         
Sub-Investigator: Syed F. Mahmood         
Sub-Investigator: Hania Shahzad         
Liaquat National Hospital
Karachi, Sindh, Pakistan, 74800
Contact: Rufina Soomro, MBBS    +923008255117    dr.rufina.soomro@lnh.edu.pk   
Sub-Investigator: Rufina Soomro         
Sponsors and Collaborators
Aga Khan University
Liaquat National Hospital & Medical College
Dow University of Health Sciences
Investigators
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Principal Investigator: Abida K. Sattar, MD, FACS Aga Khan University
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Abida K. Sattar, MD, FACS, Assistant Professor and Section Head, Aga Khan University
ClinicalTrials.gov Identifier: NCT04577846    
Other Study ID Numbers: 2020-3627-1407
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual participant data will be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abida K. Sattar, MD, FACS, Aga Khan University:
mastectomy
antibiotic prophylaxis
surgical site infection
drains
Additional relevant MeSH terms:
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Infections
Surgical Wound Infection
Pathologic Processes
Wound Infection
Postoperative Complications
Cephalexin
Anti-Bacterial Agents
Anti-Infective Agents