Commentary on: Post-Mastectomy Surgical Pocket Irrigation With Triple Antibiotic Solution vs Chlorhexidine Gluconate: A Randomized Controlled Trial Assessing Surgical Site Infections in Immediate Tissue Expander Breast Reconstruction

Author(s):  
Peter W Thompson
Author(s):  
Lyly Nguyen ◽  
Ashkan Afshari ◽  
Japjit Green ◽  
Jeremy Joseph ◽  
Jun Yao ◽  
...  

Abstract Background Post-mastectomy pocket irrigation solution choice is debated and primarily surgeon dependent. We compare triple antibiotic solution (TAS) to 0.05% chlorhexidine gluconate (CHG). Objectives The purpose of this study was to determine surgical site infection (SSI) rates after using TAS vs CHG for breast pocket irrigation in immediate tissue expander breast reconstruction. Methods A prospective, blinded, randomized controlled trial was performed in patients (18-81 years old) undergoing bilateral mastectomy with tissue expander (TE) reconstruction. In each patient, one mastectomy pocket was randomized to TAS and the other to CHG. Both the TE and the pocket were irrigated in the respective solution. The primary outcome was the incidence of surgical site infections (SSI). Secondary outcomes were rates of mastectomy flap necrosis, hematoma, and seroma. Results Eighty-eight patients undergoing bilateral immediate breast reconstruction were enrolled. Demographic and operative characteristics were equivalent as each patient served as their own control. Between the TAS and CHG groups, there was no difference in the incidence of SSI (5 [4.5%] vs 7 [8.0%], p = 0.35), including minor infections (2 [2.3%] vs 1 [1.1%], p = 0.56), major infections (2 [2.3%] vs 6 [6.8%], p = 0.15), and those resulting in explantation (2 [2.3%] vs 5 [4.5%], p = 0.25). There was also no difference in necrosis, hematoma, or seroma formation. No patients who developed SSI had radiation. Conclusions This study does not demonstrate a statistically significant difference in SSI between TAS and CHG irrigation, though TAS approached statistical significance for lower rates of infectious complications.


Author(s):  
Malke Asaad ◽  
Jesse C Selber ◽  
David M Adelman ◽  
Donald P Baumann ◽  
Victor J Hassid ◽  
...  

Abstract Background With the increased use of acellular dermal matrix (ADM) in breast reconstruction, the number of available materials has increased. There is a relative paucity of high-quality outcomes data for use of different ADMs. Objectives The goal of this study was to compare the outcomes between a human (HADM) and a bovine ADM (BADM) in implant-based breast reconstruction. Methods A prospective, single-blinded, randomized controlled trial was conducted to evaluate differences in outcomes between HADM and BADM for patients undergoing immediate tissue expander breast reconstruction. Patients with prior radiation to the index breast were excluded. Patient and surgical characteristics were collected and analyzed. Results From April 2011 to June 2016, a total of 90 patients were randomized to a mesh group, with 68 patients (HADM, 36 patients/55 breasts; BADM, 32 patients/48 breasts) included in the final analysis. Baseline characteristics were similar between the 2 groups. No significant differences in overall complication rates were identified between HADM (n = 14, 25%) and BADM (n = 13, 27%) (P = 0.85). Similar trends were identified for major complications and complications requiring reoperation. Tissue expander loss was identified in 7% of HADM patients (n = 4) and 17% of BADM patients (n = 8) (P = 0.14). Conclusions Similar complication and implant loss rates were found among patients undergoing immediate tissue expander breast reconstruction with HADM or BADM. Regardless of what material is used, careful patient selection and counseling, and cost consideration, help to improve outcomes and sustainability in immediate breast reconstruction. Level of Evidence: 2


Author(s):  
Ronnie L. Shammas ◽  
Caitlin E. Marks ◽  
Gloria Broadwater ◽  
Elliot Le ◽  
Adam D. Glener ◽  
...  

Abstract Background Psychosocial distress, depression, or anxiety can occur in up to 50% of women after a breast cancer diagnosis and mastectomy. The purpose of this study was to assess the potential benefit of lavender oil as a perioperative adjunct to improve anxiety, depression, pain, and sleep in women undergoing microvascular breast reconstruction. Methods This was a prospective, single-blinded, randomized, controlled trial of 49 patients undergoing microvascular breast reconstruction. Patients were randomized to receive lavender oil or placebo (coconut oil) throughout their hospitalization. The effect of lavender oil on perioperative stress, anxiety, depression, sleep, and pain was measured using the hospital anxiety and depression scale, Richards–Campbell Sleep Questionnaire, and the visual analogue scale. Results Twenty-seven patients were assigned to the lavender group and 22 patients were assigned to the control group. No significant differences were seen in the perioperative setting between the groups with regard to anxiety (p = 0.82), depression (p = 0.21), sleep (p = 0.86), or pain (p = 0.30) scores. No adverse events (i.e., allergic reaction) were captured, and no significant differences in surgery-related complications were observed. When evaluating the entire cohort, postoperative anxiety scores were significantly lower than preoperative scores (p < 0.001), while depression scores were significantly higher postoperatively as compared with preoperatively (p = 0.005). Conclusion In the setting of microvascular breast reconstruction, lavender oil and aromatherapy had no significant adverse events or complications; however, there were no measurable advantages pertaining to metrics of depression, anxiety, sleep, or pain as compared with the control group.


Author(s):  
elham vahabi ◽  
somayeh ghafari ◽  
somayeh haghighat

Abstract Background There are evidences that periurethral cleaning by antiseptics before catheterization decreases the risk of urinary tract infections. The purpose of this study was to Comparing 10% povidone-iodine and chlorhexidine gluconate (CHG) effectiveness in periurethral cleaning before catheterization on bacteriuria and pyuria in hospitalized patients. Methods A randomized controlled trial was used, and subjects were randomly allocated to either the 10% povidone -iodine group or the 2% chlorhexidine gluconate group. Urine specimens for culture and Analyse were collected 3 times for each subject within 5 days. Results Overall, 216 urine samples were collected in 72 subjects .There were no significant difference in results of bacteriuria of two groups immediately, 72 hrs. and 5 days after catheterization (p>0.05). There was no significant difference between two groups regarding positive pyuria immediately after sampling (p>0.05). Although its amount was significantly higher 72 hrs and 5days after catheterization in 10% povidone-iodine group than 2% chlorhexidine gluconate (p<0.05). In order to evaluate average of micro-organism in different time intervals between two groups Mann– Whitney test was used. This test showed that there was no significant difference of number of time intervals (p>0.05). Conclusions The results of this study showed that using 2% chlorhexidine gluconate reduced the amount of bacteriuria in catheterazied patients compared to 10% povidone-iodine. However this difference was not significant. Therefore doing more studies with more number of samples in this field is suggested. Trial registration: Retrospectively registered. IRCT20170712035044N2 Key words: 10% povidone-iodine- 2% chlorhexidine gluconate - Bacteriuria- Periurethral cleansing


2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S623-S624
Author(s):  
Frida Rivera-Buendía ◽  
Rafael Franco-Cendejas ◽  
Cristina G Román-López ◽  
Patricia Cornejo-Juárez ◽  
Enrique Bargalló-Rocha ◽  
...  

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Deverick J. Anderson ◽  
Iulian Ilieş ◽  
Katherine Foy ◽  
Nicole Nehls ◽  
James C. Benneyan ◽  
...  

Abstract Background Surgical site infections (SSIs) cause significant patient suffering. Surveillance and feedback of SSI rates is an evidence-based strategy to reduce SSIs, but traditional surveillance methods are slow and prone to bias. The objective of this cluster randomized controlled trial (RCT) is to determine if using optimized statistical process control (SPC) charts for SSI surveillance and feedback lead to a reduction in SSI rates compared to traditional surveillance. Methods The Early 2RIS Trial is a prospective, multicenter cluster RCT using a stepped wedge design. The trial will be performed in 29 hospitals in the Duke Infection Control Outreach Network (DICON) and 105 clusters over 4 years, from March 2016 through February 2020; year one represents a baseline period; thereafter, 8–9 clusters will be randomized to intervention every 3 months over a 3-year period using a stepped wedge randomization design. All patients who undergo one of 13 targeted procedures at study hospitals will be included in the analysis; these procedures will be included in one of six clusters: cardiac, orthopedic, gastrointestinal, OB-GYN, vascular, and spinal. All clusters will undergo traditional surveillance for SSIs; once randomized to intervention, clusters will also undergo surveillance and feedback using optimized SPC charts. Feedback on surveillance data will be provided to all clusters, regardless of allocation or type of surveillance. The primary endpoint is the difference in rates of SSI between the SPC intervention compared to traditional surveillance and feedback alone. Discussion The traditional approach for SSI surveillance and feedback has several major deficiencies because SSIs are rare events. First, traditional statistical methods require aggregation of measurements over time, which delays analysis until enough data accumulate. Second, traditional statistical tests and resulting p values are difficult to interpret. Third, analyses based on average SSI rates during predefined time periods have limited ability to rapidly identify important, real-time trends. Thus, standard analytic methods that compare average SSI rates between arbitrarily designated time intervals may not identify an important SSI rate increase on time unless the “signal” is very strong. Therefore, novel strategies for early identification and investigation of SSI rate increases are needed to decrease SSI rates. While SPC charts are used throughout industry and healthcare to improve and optimize processes, including other types of healthcare-associated infections, they have not been evaluated as a tool for SSI surveillance and feedback in a randomized trial. Trial registration ClinicalTrials.govNCT03075813, Registered March 9, 2017.


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