Antibiotic prophylaxis and surgical site infections; a prospective open label study to clinically evaluate the serum and tissue concentration of single dose prophylactic ceftriaxone in laparoscopic cholecystectomy

Sheikh, Salim; Malik, Neeraj Kumar; Karim, Bushra

doi:10.1007/s00228-020-02940-x

Cited by 5 publications

(4 citation statements)

References 29 publications

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“…Based on Table 4, the most commonly given single antibiotic was ceftriaxone (95.58%), and the most commonly given combination was ceftriaxone-metronidazole (71.4%). That is consistent with the study conducted (Sheikh et al, 2020), which revealed that ceftriaxone as monotherapy has good efficacy for antibiotic prophylaxis. The most commonly used antibiotic for prophylaxis in digestive surgery is ceftriaxone, the cefalosporin 3 rd generation (Narulita et al, 2021).…”

Section: Strengthening Expanding and Deepeningsupporting

confidence: 92%

Evaluation of Administration Prophylactic Antibiotic against Incidence of Surgical Site Infection in Post Appendectomy at Panembahan Senopati Hospital, Indonesia

Adzillina,

Sundari,

Ijabah

2024

JMMR

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Appendicitis is a prevalent abdominal surgical emergency in Indonesia, occurring at a rate of 5 per 1,000 people, with around 10 million cases each year. Appendectomy, the surgical removal of the vermiform, is the primary treatment for appendicitis but carries a high risk of surgical site infections. Prophylactic antibiotics are given to minimize the risk of infection resulting from surgery, administered in accordance with established guidelines. This study aims to evaluate the administration of antibiotic prophylactic against SSIs. This study used a mixed-methods approach to evaluate prophylactic antibiotic administration and the incidence of surgical site infection in post-appendectomy patients. The researchers conducted in-depth interviews with surgeons and nurses and an analytical observational study with a cross-sectional design, observing various indicators such as the timing and duration of prophylactic antibiotic administration and the presence of surgical site infections. The study found that the duration of antibiotic administration ≤24 hours had a higher number of infection-free patients (62.50%). The researchers analyzed the relationship between the duration of antibiotic administration and surgical site infection in post-appendectomy patients and found a significant relationship (p <0.05) at the hospital. There is a relationship between prophylactic antibiotic administration and surgical site infection. All patients were given prophylactic antibiotics with appropriate timing, duration, and method of administration.

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Section: Strengthening Expanding and Deepeningsupporting

confidence: 92%

Evaluation of Administration Prophylactic Antibiotic against Incidence of Surgical Site Infection in Post Appendectomy at Panembahan Senopati Hospital, Indonesia

Adzillina,

Sundari,

Ijabah

2024

JMMR

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“…[7][8][9] The medical conditions known to be associated with lower local concentrations include peripheral vascular disease, obesity, and diabetes. [9][10][11][12] To overcome this hurdle, various techniques for delivering antibiotics directly to the surgical site have been developed. Such a local drug delivery system is D-PLEX (PolyPid Ltd, Petah Tikva, Israel), which pairs an innovative Polymer-Lipid Encapsulation matriX (PLEX) technology platform with the broad-spectrum antibiotic, doxycycline.…”

Section: Introductionmentioning

confidence: 99%

Preclinical In-Vivo Safety and Toxicokinetics of D-PLEX100 in an Abdominal Surgery Incision Model in Juvenile Miniature Swine

Ramot,

Nyska,

Dvir

et al. 2023

Int J Toxicol

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D-PLEX100 (D-PLEX) is a novel product candidate made of a polymer-lipid-based matrix (PLEX platform) which contains doxycycline that is being released at a constant rate for 30 days. D-PLEX was developed to prevent surgical site infections, which are a major global health challenge. Previous studies have shown its safety in adult humans, adult swine, and adult rabbits. The aim of this study was to assess the toxicity and safety of D-PLEX also in juvenile animals to support future clinical trials in pediatric patients. Yucatan miniature swine were selected as a model, primarily due to their relatively larger mass. D-PLEX or placebo (formulation without doxycycline) was administered locally to abdominal incisions, and the animal's safety parameters were followed for 9 months and compared to sham-control swine. There was no evidence of any systemic safety concern or local toxicity at the incision site in D-PLEX-treated animals. D-PLEX was detected after 1 month and was fully resorbed at the 3-month time point. The surgical incision sites were fully healed at the 6-month time point in all D-PLEX-treated animals. Toxicokinetic (TK) assessments revealed that doxycycline exhibited low Cmax and therefore minimal systemic exposure following a single dose of local administration. This study provides evidence for the safety of D-PLEX and PLEX-based formulation in juvenile miniature swine and supports its further testing in clinical pediatric population. In addition, it can be used as a reference for future preclinical studies aiming to evaluate the safety of other PLEX-based product candidates for the pediatric population.

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“…As Sheikh et al note, “In clinical practice, plasma antibiotic concentrations are used as a surrogate marker for pharmacologic effect. However, for predicting therapeutic efficacy, the tissue concentration of antibiotic is more important than the plasma concentrations” [ 5 ]. Given that systematically measured concentrations are typically higher than those found in the subcutaneous tissues surrounding and within the wound bed [ 6 ], particularly for patients with obesity, diabetes, and peripheral vascular disease [ 7 ], low loco-regional tissue penetration, and hence duration of effect, is likely a significant and overlooked issue in SSI prophylaxis measures.…”

Section: Introductionmentioning

confidence: 99%

A prospective, randomized assessment of a novel, local antibiotic releasing platform for the prevention of superficial and deep surgical site infections

Zmora

Stark²,

Belotserkovsky³

et al. 2022

Tech Coloproctol

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Background Despite significant advances in infection control guidelines and practices, surgical site infections (SSIs) remain a substantial cause of morbidity, prolonged hospitalization, and mortality among patients having both elective and emergent surgeries. D-PLEX100 is a novel, antibiotic-eluting polymer–lipid matrix that supplies a high, local concentration of doxycycline for the prevention of superficial and deep SSIs. The aim of our study was to evaluate the safety and efficacy of D-PLEX in addition to standard of care (SOC) in preventing superficial and deep surgical site infections for patients undergoing elective colorectal surgery. Methods From October 10, 2018 to October 6, 2019, as part of a Phase 2 clinical trial, we randomly assigned 202 patients who had scheduled elective colorectal surgery to receive either standard of care SSI prophylaxis or D-PLEX100 in addition to standard of care. The primary objective was to assess the efficacy of D-PLEX100 in superficial and deep SSI reduction, as measured by the incidence of SSIs within 30 days, as adjudicated by both an individual assessor and a three-person endpoint adjudication committee, all of whom were blinded to study-group assignments. Safety was assessed by the stratification and incidence of treatment-emergent adverse events. Results One hundred and seventy-nine patients were evaluated in the per protocol population, 88 in the intervention arm [51 males, 37 females, median age (64.0 range: 19–92) years] and 91 in the control arm [57 males, 34 females, median age 64.5 (range: 21–88) years]. The SSI rate within 30 day post-index surgery revealed a 64% relative risk reduction in SSI rate in the D-PLEX100 plus standard of care (SOC) group [n = 7/88 (8%)] vs SOC alone [n = 20/91 (22%)]; p = 0.0115. There was no significant difference in treatment-emergent adverse events. Conclusions D-PLEX100 application leads to a statistically significant reduction in superficial and deep surgical site infections in this colorectal clinical model without any associated increase in adverse events.

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Antibiotic prophylaxis and surgical site infections; a prospective open label study to clinically evaluate the serum and tissue concentration of single dose prophylactic ceftriaxone in laparoscopic cholecystectomy

Cited by 5 publications

References 29 publications

Evaluation of Administration Prophylactic Antibiotic against Incidence of Surgical Site Infection in Post Appendectomy at Panembahan Senopati Hospital, Indonesia

Evaluation of Administration Prophylactic Antibiotic against Incidence of Surgical Site Infection in Post Appendectomy at Panembahan Senopati Hospital, Indonesia

Preclinical In-Vivo Safety and Toxicokinetics of D-PLEX100 in an Abdominal Surgery Incision Model in Juvenile Miniature Swine

A prospective, randomized assessment of a novel, local antibiotic releasing platform for the prevention of superficial and deep surgical site infections

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