Surgical Site Infection With 0.05% Chlorhexidine (CHG) Compared to Triple Antibiotic Irrigation
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|ClinicalTrials.gov Identifier: NCT02395614|
Recruitment Status : Recruiting
First Posted : March 23, 2015
Last Update Posted : March 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Chlorhexidine irrigation Drug: triple antibiotic irrigation||Not Applicable|
Breast reconstruction with tissue expander (TE) remains the gold standard of breast restoration after mastectomy. During the first stage of reconstruction, a TE is placed under chest muscles and slowly inflated postoperatively over the period of several weeks. After desired volume of TE is achieved it is exchanged for permanent breast prosthesis during another surgery (second stage of reconstruction). Postoperative wound infection after placement of TE can lead to devastating consequences both for patients and a surgeon. Frequently, surgical site infection requires additional surgeries and resulting in the removal of TE and long term IV antibiotic therapy. Therefore, during breast reconstruction procedures all possible measures are implemented to reduce postoperative infection rate. Several studies demonstrated that intra-operative irrigation of surgical wounds with antibiotic containing solution before insertion of breast TE decreases postoperative infection rate. This approach is currently adopted as a standard of care within plastic surgery clinical community.
The investigators intend to perform a prospective randomized study and compare the incidence of surgical wound infection between mastectomy wounds irrigated with triple antibiotic solution (one side) and 0.05% CHG (opposite side) in patients undergoing bilateral breast reconstruction.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Incidence of Surgical Site Infection After Irrigation of Surgical Pocket With 0.05% Chlorhexidine Compared to Triple Antibiotic Solution in Post-mastectomy Breast Reconstruction|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2022|
Experimental: Chlorhexidine irrigation
0.05% chlorhexidine solution (IrriSept®) commercially prepared in 450 ml bottles for irrigation. Each patient will receive triple antibiotic solution on one breast and the CHG on the other breast.
Drug: Chlorhexidine irrigation
- 0.05% chlorhexidine solution (IrriSept®) commercially prepared in 450 ml bottles will be used to irrigate one breast pocket. Each patient will receive triple antibiotic solution on one breast and the CHG on the other breast.
Other Name: CHG
Active Comparator: triple antibiotic irrigation
triple antibiotic solution will contain 1 g of cefazolin, 50,000 U of bacitracin, and 80 mg of gentamicin in 500 mL of normal saline (NS). If the patient is allergic to either component - the allergen will not be used in the solution - for irrigation. Each patient will receive triple antibiotic solution on one breast and the CHG on the other breast.
Drug: triple antibiotic irrigation
-triple antibiotic solution will contain 1 g of cefazolin, 50,000 U of bacitracin, and. Each patient will receive triple antibiotic solution on one breast and the CHG on the other breast.
80 mg of gentamicin in 500 mL of NS. If the patient is allergic to either component - the allergen will not be used in the solution - to irrigate one breast pocket
Other Name: gentamicin, cefazolin and bacitracin
- frequency of surgical site infection as defined by Centers for Disease Control and Prevention (CDC ) [ Time Frame: 30 days ]frequency of surgical site infection as defined by CDC, http://www.cdc.gov/hai/ssi/ssi.html)
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): NCT02395614
|Contact: Kent Higdon, MDfirstname.lastname@example.org|
|Contact: Julia Yao, BSNemail@example.com|
|United States, Tennessee|
|Vanderbilt University Medical Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Kent Higdon, MD 615-936-0160 firstname.lastname@example.org|
|Contact: Marcia Spear, DNP 615-343-8426 email@example.com|
|Principal Investigator:||Kent Higdon, MD||Vanderbilt University Medical Center|