Ignite Creation Date:
2024-05-06 @ 3:16 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04577846
Status:
UNKNOWN
Last Update Posted:
2020-10-08
First Post:
2020-10-01
Brief Title:
SSI Rates in Patients Undergoing Mastectomy Without Reconstruction- A Multicenter Double-blinded RCT
Sponsor:
Aga Khan University
Organization:
Aga Khan University
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Introduction
Worldwide breast cancer comprises 104 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 continuationduration 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 preperioperative 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 infectionSSI rates at the mastectomy wound site or the drains 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
Worldwide breast cancer comprises 104 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 continuationduration 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 preperioperative 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 infectionSSI rates at the mastectomy wound site or the drains 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None