A Pilot Randomised Clinical Trial Comparing a Short-Term Perioperative Prophylaxis Regimen to a Long-Term Standard Protocol in Equine Colic Surgery

Background: For surgical interventions classified as clean or clean-contaminated, including laparotomy, guidelines in human and veterinary medicine recommend a short-term perioperative antibiotic prophylaxis (PAP). In equine colic surgery, however, PAP commonly exceeds 24 h. Objectives: The aim of this study was to compare a single-shot to a 5-day lasting PAP considering surgical site infections (SSI) and other adverse effects probably associated with the particular antimicrobial regimen. Study design: The study was designed as a randomised non-inferiority pilot study including horses subjected to colic surgery while receiving one of two distinct PAP regimens. Methods: All horses (n = 67) included in the study received the standard physical examination before and after surgery. Colic surgery was performed according to the current standard of the clinic. Horses were randomly assigned to two groups, receiving either the “single-shot” or the “5-day lasting” antibiotic prophylaxis. The “single-shot” group (n = 30) received penicillin and gentamicin only once before and, if needed, during surgery, whereas the “5-day lasting” group (n = 37) received antibiotics for five days. In addition to the standard laboratory examinations, serum amyloid A and fibrinogen were determined preoperatively and during five days after surgery. SSI, postoperative colitis and haemolytic anaemia were classified as postoperative complications potentially related to antibiotic use. Results: The outcome of this preliminary non-inferiority clinical trial showed that the occurrence of postoperative adverse events (i.e., SSI, postoperative colitis and haemolytic anaemia) lacked significant differences between the study groups. Main limitations: The main limitations of this study are the limited group sizes and our inability to blind the study. Conclusions: Single-shot PAP seems to be an alternative approach considering the 5-day lasting protocol commonly used in equine abdominal surgery. However, a proper hygiene management together with a close clinical and laboratory monitoring of the equine patient is indispensable.

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The “Torment” of Surgical Antibiotic Prophylaxis among Surgeons

Antibiotics ◽

10.3390/antibiotics10111357 ◽

2021 ◽

Vol 10 (11) ◽

pp. 1357

Author(s):

Massimo Sartelli ◽

Federico Coccolini ◽

Angeloantonio Carrieri ◽

Francesco M. Labricciosa ◽

Enrico Cicuttin ◽

...

Keyword(s):

Acute Kidney Injury ◽

Side Effects ◽

Antibiotic Prophylaxis ◽

Kidney Injury ◽

Surgical Site Infections ◽

Surgical Interventions ◽

Clostridioides Difficile ◽

Clostridioides Difficile Infection ◽

Surgical Antibiotic Prophylaxis ◽

Operative Measures

Surgical antibiotic prophylaxis (SAP) is one of the peri-operative measures for preventing surgical site infections (SSIs). Its goal is to counteract the proliferation of bacteria in the surgical site during intervention in order to reduce the risk of SSIs. SAP should be administered for surgical interventions where the benefit expected (prevention of SSIs) is higher compared to the risk (serious side effects, such as acute kidney injury, Clostridioides difficile infection, and the spread of antimicrobial resistance). In prescribing SAP, surgeons should have both the awareness necessary “to handle antibiotics with care”, and the knowledge required to use them appropriately.

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A study on comparison of short term three dose antibiotic prophylaxis with conventional prolonged postoperative antibiotic coverage in development of surgical site infections

International Surgery Journal ◽

10.18203/2349-2902.isj20182063 ◽

2018 ◽

Vol 5 (6) ◽

pp. 2114

Author(s):

M. V. Saila Suman Konidala ◽

Padmaja Rani Gopalam ◽

Jithendra Kandati

Keyword(s):

Risk Factors ◽

Antibiotic Prophylaxis ◽

Wound Infection ◽

Prophylactic Antibiotic ◽

Surgical Site Infections ◽

Short Term ◽

Group A ◽

Group B ◽

Associated Risk Factors ◽

Antibiotic Coverage

Background: Surgical site infections are still an increasing threat to the surgeons despite advances in techniques of surgery, patient care and sterilization practices. Most of the studies state that pre-operative antibiotic prophylaxis is effective in reducing the risk of wound infection in surgical procedures and has been a standard practice followed in many surgeries. Prolonged administration of prophylactic antibiotic has been associated with development of resistant bacterial strains and predisposes the patient in development of wound infection. The aim of the present study is to study the effectiveness of short term antibiotic coverage during decisive period in prevention of post-operative infection in surgical procedures.Methods: A prospective randomized and comparative study was done for one year with 100 cases divided into two groups A and B. Group A received prophylactic Ceftriaxone three doses intravenously, 12 h before surgery 1st dose, 1h before surgery 2nd dose and third 10h after surgery. Group B received Ceftriaxone twice daily for 5 days after surgery. The two groups were compared for development of SSI and associated risk factors.Results: The mean age of the total study group was 37.11± 12.12 years with 60% of males and 40% females. Overall incidence of SSI in study was 24% with Group A 10% and 14% in group B. Anemia, associated drain, increased BMI and undernourishment was associated risk factors and a statistically significant association was found with these risk factors in present study. Pseudomonas and Methicillin resistant staphylococcus aureus were the isolates in the study.Conclusions: Present study strongly recommends the use of antibiotics during surgery than administration after surgery. More care and proper management of the cases are required with associated risk factors like increased BMI, presence of drain and low Hb%. Large multicentric studies are further required to establish further associated risk factors and to identify the local pathogens and their resistance pattern. Appropriate use of antibiotics can substantially reduce the emergence of resistant pathogens and limit the cost of treatment.

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Reduction of Perioperative Antibiotic Prophylaxis in Open Radical Cystectomy with Ileal Conduit Is Feasible: Results of a Prospective Clinical Trial

Urologia Internationalis ◽

10.1159/000520564 ◽

2021 ◽

pp. 1-7

Author(s):

Laila Schneidewind ◽

Laura Torabi ◽

Desiree L. Dräger ◽

Oliver W. Hakenberg

Keyword(s):

Clinical Trial ◽

Antibiotic Prophylaxis ◽

Radical Cystectomy ◽

Ileal Conduit ◽

Prospective Clinical Trial ◽

Ethical Review ◽

Fisher Exact Test ◽

Antibiotic Administration ◽

Single Shot ◽

Tract Infections

Introduction: The aim of this study is to perform a prospective clinical trial in antibiotic prophylaxis, infectious complication, and colonization of ileal conduit (IC) following radical cystectomy (RC) since urinary tract infections (UTIs) and surgical site infections (SSIs) contribute significantly to the morbidity associated with RC and IC. Moreover, an optimal regimen of antibiotic prophylaxis has not been established, yet. Material and Methods: After a positive vote of ethical review committee and the registration at the German Clinical Trials Register (DKRS 00020406), we started a prospective clinical unicentric not interventional study. The urine samples were collected by sterile catheterization of the IC. All patients received an antibiotic prophylaxis with 3 × 500 mg metronidazole and 3 × 1.5 g cefuroxime intravenously for 3 days starting on the day before RC. Ureteral stents got removed on days 9 and 10 after surgery without prior antibiotic administration. The student t test and the χ2 test or the Fisher exact test were used. For risk factor assessment, the univariate Cox regression method was applied. Results: Nineteen male (63.3%) and 11 female patients (36.7%) with a median age of 70.5 years were included. Three patients developed complicated UTI (10%) on day 12 after RC with E. faecium and needed antibiotic treatment with meropenem (Clavien-Dindo II). Two patients (6.7%) developed SSI with E. faecium and needed surgery (Clavien-Dindo IIIb). Palliative RC (p < 0.0001), prior radiation therapy (p < 0.0001), and timeframe >3 months from diagnosis to RC (p = 0.036) are significantly associated with the development of complicated UTI. Interestingly, the IC got colonized with Staph. haemolyticus at day 12 after RC (n = 12; 40.0%). We must assume that our data have some limitations like a unicentric study population. Conclusion: Further evaluation of reduction to single-shot antibiotic prophylaxis in nonpalliative RC with IC could be feasible.

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APOS - Antibiotic Prophylaxis For Preventing Infectious Complications In Orthognathic Surgery: Study Protocol For A Phase III, Multicentre, Randomised, Controlled, Double Blinded, Clinical Trial With Two Parallel Study Arms

10.21203/rs.3.rs-439954/v1 ◽

2021 ◽

Author(s):

Oliver Ristow ◽

Christof Hofele ◽

Philipp Münch ◽

Sylvia Danner ◽

Anja Dietzel ◽

...

Keyword(s):

Clinical Trial ◽

Antibiotic Prophylaxis ◽

Orthognathic Surgery ◽

Treatment Guidelines ◽

Specific Treatment ◽

Surgical Site Infections ◽

Phase Iii ◽

Parallel Study ◽

Randomised Controlled ◽

Double Blinded

Abstract Background: It is a constant debate among surgeons whether the use of prolonged postoperative antibiotics may reduce surgical site infection rates. As specific treatment guidelines are still lacking, many surgeons continue to use broad-spectrum antibiotics, causing not only increased costs but also contributing to the potential for antibiotic resistance. Hence, there is an urgent need for an appropriately designed prospective clinical trial, to investigate whether a prophylactic use of antibiotics after surgery actually decreases surgical site infections to a clinically relevant degree.Methods: This study presents a multicentre, randomised, controlled, double-blinded, clinical trial with two parallel study arms to demonstrate that no postoperative antibiotic prophylaxis (AP) is not inferior to antibiotic prophylaxis with respect to surgical site infections in patients having undergone orthognathic surgery. The primary efficacy endpoint is defined as the occurrence of postoperative surgical site infections within 30 days of surgery. Secondary endpoints are further efficacy and subject-oriented parameters within 90 days after surgery. The entire trial is planned for 54 months, with an enrolment of 1420 patients over 39 months by 14 national participating centres. Discussion: As a highly standardised procedure on an exceeding, healthy and young homogenous study population and identical processes all over the world, elective orthognathic surgery as clean-contaminated procedure provides comparable intervention groups with balanced baseline characteristics, comparable surgical duration, even when performed within multiple centres. Therefore, evaluating antibiotic prophylaxis after orthognathic surgery will be of high scientific value representable for other surgical procedures.Trial registration: DRKS - German Clinical Trials Register - DRKS00022838; EudraCT No. 2020-001397-30

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APOS—antibiotic prophylaxis for preventing infectious complications in orthognathic surgery: study protocol for a phase III, multicentre, randomised, controlled, double blinded, clinical trial with two parallel study arms

Trials ◽

10.1186/s13063-021-05710-x ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Oliver Ristow ◽

Christof Hofele ◽

Philipp Münch ◽

Sylvia Danner ◽

Anja Dietzel ◽

...

Keyword(s):

Clinical Trial ◽

Antibiotic Prophylaxis ◽

Orthognathic Surgery ◽

Treatment Guidelines ◽

Specific Treatment ◽

Surgical Site Infections ◽

Phase Iii ◽

Parallel Study ◽

Randomised Controlled ◽

Double Blinded

Abstract Background It is a constant debate among surgeons whether the use of prolonged postoperative antibiotics may reduce surgical site infection rates. As specific treatment guidelines are still lacking, many surgeons continue to use broad-spectrum antibiotics, causing not only increased costs but also contributing to the potential for antibiotic resistance. Hence, there is an urgent need for an appropriately designed prospective clinical trial, to investigate whether a prophylactic use of antibiotics after surgery actually decreases surgical site infections to a clinically relevant degree. Methods This study presents a multicentre, randomised, controlled, double-blinded, clinical trial with two parallel study arms to demonstrate that no postoperative antibiotic prophylaxis (AP) is not inferior to antibiotic prophylaxis with respect to surgical site infections in patients having undergone orthognathic surgery. The primary efficacy endpoint is defined as the occurrence of postoperative surgical site infections within 30 days of surgery. Secondary endpoints are further efficacy and subject-oriented parameters within 90 days after surgery. The entire trial is planned for 54 months, with an enrolment of 1420 patients over 39 months by 14 national participating centres. Discussion As a highly standardised procedure on an exceeding, healthy and young homogenous study population and identical processes all over the world, elective orthognathic surgery as clean-contaminated procedure provides comparable intervention groups with balanced baseline characteristics, comparable surgical duration, even when performed within multiple centres. Therefore, evaluating antibiotic prophylaxis after orthognathic surgery will be of high scientific value representable for other surgical procedures. Trial registration DRKS—German Clinical Trials Register—DRKS00022838; EudraCT No. 2020-001397-30. Registered on 29 March 2021

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