SSI Rates in Patients Undergoing Mastectomy Without Reconstruction- A Multicenter, Double-blinded RCT.
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|ClinicalTrials.gov Identifier: NCT04577846|
Recruitment Status : Not yet recruiting
First Posted : October 8, 2020
Last Update Posted : October 8, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||384 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
A placebo capsule filled with inert material for the duration of the drains which usually is about 14 days.
- Surgical Site Infection (SSI) [ Time Frame: up to 30 days. ]
Standard CDC criteria:
- purulent drainage from the incision or drain site;
- organisms isolated from an aseptically obtained culture of fluid or tissue;
- deliberate opening of the incision by a surgeon in patients having either tenderness, localized swelling, redness, or warmth; or
- diagnosis of SSI by the surgeon or study wound assessor or
- prescription of therapeutic antibiotics;
- Patients clinically diagnosed and documented to have cellulitis.
- 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
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
|Contact: Abida K. Sattar, MD, FACS||+92 345 email@example.com; firstname.lastname@example.org|
|Dow University of Health Sciences|
|Karachi, Sindh, Pakistan, 74200|
|Contact: Omema Saleem, MBBS +923333739944 email@example.com|
|Sub-Investigator: Omema Saleem|
|Aga Khan University Hospital|
|Karachi, Sindh, Pakistan, 7480 0|
|Contact: Abida K. Sattar, MD, FACS +9221 34864751 firstname.lastname@example.org|
|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 email@example.com|
|Sub-Investigator: Rufina Soomro|
|Principal Investigator:||Abida K. Sattar, MD, FACS||Aga Khan University|