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

2021 ◽  
Author(s):  
Lyly Nguyen ◽  
Ashkan Afshari ◽  
Japjit Green ◽  
Jeremy Joseph ◽  
Jun Yao ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Breast Reconstruction ◽  
Controlled Trial ◽  
Tissue Expander ◽  
Surgical Site Infections ◽  
Chlorhexidine Gluconate ◽  
Bilateral Mastectomy ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Antibiotic Solution

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.

scholarly journals 10% povidone-iodine versus 2% chlorhexidine gluconate for Periurethral cleansing before catheterization among hospitalized patients: A randomized controlled trial

2019 ◽  
Author(s):  
elham vahabi ◽  
somayeh ghafari ◽  
somayeh haghighat
Keyword(s):  
Randomized Controlled Trial ◽  
Povidone Iodine ◽  
Controlled Trial ◽  
Chlorhexidine Gluconate ◽  
Hospitalized Patients ◽  
Time Intervals ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Tract Infections ◽  
Urine Specimens

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

Allograft vs Xenograft Bioprosthetic Mesh in Tissue Expander Breast Reconstruction: A Blinded Prospective Randomized Controlled Trial

2021 ◽  
Author(s):  
Malke Asaad ◽  
Jesse C Selber ◽  
David M Adelman ◽  
Donald P Baumann ◽  
Victor J Hassid ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Breast Reconstruction ◽  
Controlled Trial ◽  
Tissue Expander ◽  
Final Analysis ◽  
Immediate Breast Reconstruction ◽  
Complication Rates ◽  
Level Of Evidence ◽  
Dermal Matrix ◽  
Randomized Controlled

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

scholarly journals The The Effectiveness of Early Mobilization Time on Balance and Functional Ability after Ischemic Stroke

2019 ◽  
Vol 7 (7) ◽  
pp. 1088-1092
Author(s):  
Umi Budi Rahayu ◽  
Samekto Wibowo ◽  
Ismail Setyopranoto
Keyword(s):  
Randomized Controlled Trial ◽  
Ischemic Stroke ◽  
Functional Ability ◽  
Controlled Trial ◽  
Early Mobilization ◽  
Berg Balance Scale ◽  
Early Mobilisation ◽  
Inclusion Criteria ◽  
Randomized Controlled ◽  
Significant Difference

BACKGROUND: Early mobilisation (EM) after-ischemic stroke is a motor learning intervention aimed to restore nerve cells and to improve balance and functional ability. Unfortunately, the study of when this intervention began has not been widely studied. AIM: On this study was compared the effect of EM started at 24 hours and 48 hours after an ischemic stroke on balance and functional ability. MATERIAL AND METHODS: Randomized controlled trial involving 40 patients on 2 groups meeting predefined inclusion criteria. The levels of balance were measured using the Berg Balance Scale, and the functional ability was measured using the Barthel Index, at 5th and 7th day. RESULTS: A significant difference was observed in both balance (p = 0.038) and functional ability (p = 0.021) obtained on the 7th day of assessment between both groups. A significant difference on the 5th day was observed only in the functional ability (p = 0.002) and not in the balance (p = 0.147), between the groups. CONCLUSION: EM started at 24 hours after the ischemic stroke has been found to have a better impact on balance and functional ability compared to that at 48 hours.

scholarly journals Effect of leg wrapping technique on prevention of spinal induced hypotension and fetal acidosis during cesarean section: Randomized controlled trial

2019 ◽  
Vol 10 (2) ◽  
pp. 70
Author(s):  
Samah Nasser Abd El-Aziz El-Shora ◽  
Amina Mohamed Rashad El-Nemer
Keyword(s):  
Randomized Controlled Trial ◽  
Cesarean Section ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cost Effective ◽  
Control Group ◽  
Induced Hypotension ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Wrapping Technique

Background and aim: Hypotension during cesarean section (CS) under spinal anesthesia has been a subject of scientific study for more than 50 years and the search for the most effective strategy to achieve hemodynamic stability remains challenging. Aim: The study was carried out to apply leg wrapping technique for the prevention of spinal-induced hypotension (SIH) during CS.Methods: Randomized Controlled Trial design was utilized at cesarean delivery operating room Mansoura General Hospital in El-Mansoura City during the period from May 2018 to November 2018. A purposive sample of 88 pregnant women, assigned randomly to an intervention group (n = 44) in which their legs wrapped with elastic crepe bandage and control group (n = 44) in which no wrapping was done. Data collected for maternal, neonatal hemodynamic and signs of hypotension, the feasibility of application and cost analysis.Results: There was a statistically significant difference in the incidence of SIH and Ephedrine use among both groups (18.20% in leg wrapping group whereas 75% in control group). In addition, neonatal acidosis and NICU admission were less among leg wrapping group (11.40%, 9.10% respectively). Economically, leg wrapping technique was cost effective compared to the cost of the hospital regimen for treating SIH and admission to (NICU).Conclusion and recommendations: Leg wrapping technique was cost effective and an efficient method for decreasing SIH, neonatal acidosis and Ephedrine administration. It is recommended to apply leg wrapping technique in maternal hospitals' protocol of care for decreasing SIH during CS.

The Effect of Lavender Oil on Perioperative Pain, Anxiety, Depression, and Sleep after Microvascular Breast Reconstruction: A Prospective, Single-Blinded, Randomized, Controlled Trial

2021 ◽  
Author(s):  
Ronnie L. Shammas ◽  
Caitlin E. Marks ◽  
Gloria Broadwater ◽  
Elliot Le ◽  
Adam D. Glener ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Breast Reconstruction ◽  
Controlled Trial ◽  
Depression Scale ◽  
Control Group ◽  
Lavender Oil ◽  
Entire Cohort ◽  
Randomized Controlled ◽  
Anxiety Depression

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.

scholarly journals Interest of a standardized hypnotic message for the reduction of pain and anxiety in cancer patients treated by capsaicin patch for neuropathic pain: a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Rémi Etienne ◽  
Myriam Laurent ◽  
Aline Henry ◽  
Antoine Bioy ◽  
Julia Salleron ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Neuropathic Pain ◽  
Rating Scales ◽  
Controlled Trial ◽  
Standard Group ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Numerical Rating ◽  
Reduction Of Pain ◽  
The Impact

Abstract Background Neuropathic pain is characterized by spontaneous painful symptoms. Medical therapies include the use of a capsaicin 8% patch (Qutenza®, Grünenthal Gmbh, Germany), and patients may experience a sharp burning sensation at application and removal of the patch. This study aimed to evaluate the impact of playing a standardized hypnosis recording during application, on the pain and anxiety induced by capsaicin treatment. Methods In a randomized, controlled trial, we assessed the benefits of the intervention firstly on pain and secondly on anxiety, as measured using numerical rating scales. All patients had application of the capsaicin patch, including the possibility for the patient to apply a cold patch. Participants were randomly assigned to one of 3 groups, namely the “Standard group” (no intervention), “Hypnosis group”, in which a standardized hypnotic message was played during application, or the “Music group” in which relaxing music was played during application of the patch. Results Sixty-nine patients were included. Overall, there was no significant difference in pain scores between groups (p = 0.355). Compared to standard application, anxiety was significantly lower in the hypnosis group after application (p = 0.007), with no significant difference between the standard and music arms (p = 0.271), or between the hypnosis and music arms (p = 0.423). Conclusions Listening to a standardized hypnotic message during application of a capsaicin patch was found to significantly lower anxiety. These findings indicate that the use of a hypnotic message can reduce discomfort and warrant its evaluation in other indications of pain or anxiety during treatment procedures. Trial registration NCT02822625.

scholarly journals Methylprednisolone or dexamethasone, which one is superior corticosteroid in the treatment of hospitalized COVID-19 patients: a triple-blinded randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Keivan Ranjbar ◽  
Mohsen Moghadami ◽  
Alireza Mirahmadizadeh ◽  
Mohammad Javad Fallahi ◽  
Vahid Khaloo ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Clinical Status ◽  
Intervention Group ◽  
Length Of Hospital Stay ◽  
Ordinal Scale ◽  
Control Group ◽  
Randomized Controlled ◽  
Group Data ◽  
Significant Difference

Abstract Background Although almost a year has passed since the Coronavirus disease 2019 (COVID-19) outbreak and promising reports of vaccines have been presented, we still have a long way until these measures are available for all. Furthermore, the most appropriate corticosteroid and dose in the treatment of COVID-19 have remained uncertain. We conducted a study to assess the effectiveness of methylprednisolone treatment versus dexamethasone for hospitalized COVID-19 patients. Methods In this prospective triple-blinded randomized controlled trial, we enrolled 86 hospitalized COVID-19 patients from August to November 2020, in Shiraz, Iran. The patients were randomly allocated into two groups to receive either methylprednisolone (2 mg/kg/day; intervention group) or dexamethasone (6 mg/kg/day; control group). Data were assessed based on a 9-point WHO ordinal scale extending from uninfected (point 0) to death (point 8). Results There were no significant differences between the groups on admission. However, the intervention group demonstrated significantly better clinical status compared to the control group at day 5 (4.02 vs. 5.21, p = 0.002) and day 10 (2.90 vs. 4.71, p = 0.001) of admission. There was also a significant difference in the overall mean score between the intervention group and the control group, (3.909 vs. 4.873 respectively, p = 0.004). The mean length of hospital stay was 7.43 ± 3.64 and 10.52 ± 5.47 days in the intervention and control groups, respectively (p = 0.015). The need for a ventilator was significantly lower in the intervention group than in the control group (18.2% vs 38.1% p = 0.040). Conclusion In hospitalized hypoxic COVID-19 patients, methylprednisolone demonstrated better results compared to dexamethasone. Trial registration The trial was registered with IRCT.IR (08/04/2020-No. IRCT20200204046369N1).

scholarly journals Infectious Disease Team Review Using Antibiotic Switch and Discharge Criteria Shortens the Duration of Intravenous Antibiotic: A Single-Center Cluster-Randomized Controlled Trial in Thailand

2020 ◽  
Vol 7 (12) ◽  
Author(s):  
Thanyarak Wongkamhla ◽  
Buddharat Khan-asa ◽  
Sasima Tongsai ◽  
Nasikarn Angkasekwinai
Keyword(s):  
Infectious Disease ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomized Controlled Trial ◽  
Defined Daily Dose ◽  
Randomized Controlled ◽  
Days Of Therapy ◽  
Significant Difference ◽  
Cluster Randomized ◽  
Discharge Criteria

Abstract Background Strategies have been recommended to optimize early antibiotic (ATB) switching from intravenous (IV) to oral ATB. This study aimed to determine whether infectious disease (ID) team review using ATB switch and discharge criteria would shorten the duration of IV ATB and length of hospital stay (LOS). Methods This cluster-randomized controlled trial was conducted in 8 general medical wards as cluster units at Siriraj Hospital during January–October 2019. The ID team review with checklist criteria was performed on the third, fifth, and seventh day of IV-ATB treatment to determine (1) the suitability of switching to oral ATB or outpatient parenteral ATB therapy and (2) early discharge for patients receiving IV-ATB versus control. The primary outcomes were LOS and the duration or days of therapy (DOT) or defined daily dose (DDD) of IV-ATB therapy. Results Four wards each were randomly assigned to the intervention and control groups (46 patients/cluster, 184 patients/arm). No significant difference was observed between intervention and controls for median duration of IV-ATB therapy (7 vs 7 days) and LOS (9 vs 10 days). A significantly shorter duration of IV ATB was observed in patients without sepsis in the intervention group when measured by DOT (7 vs 8 days, P = .027) and DDD (7 vs 9, P = .017) in post hoc analysis. Conclusions Infectious disease team review using checklist criteria did not result in a shorter duration of IV-ATB and LOS in overall patients. Further study is needed to determine whether faster culture turnaround time or advanced testing will reduce the duration of IV-ATB therapy.

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