Gentamicin-impregnated Collagen Sponges Research Articles

Pharmacokinetic study of local and systemic gentamicin concentrations after subcutaneous implantation of a gentamicin-impregnated collagen sponge in dogs

This study evaluated the pharmacokinetics of commercial gentamicin-impregnated collagen sponges (GICS) applied subcutaneously in dogs. In six healthy beagles, an 11 ×6 cm subcutaneous pocket was created, a folded 10×10 cm GICS was inserted, and saline was injected to mimic a seroma. Wound fluid samples were aspirated, and the gentamicin concentration was determined. Simultaneously, blood samples were collected to evaluate the corresponding systemic gentamicin concentration. All samples were collected before and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120, and 168 hours after GICS placement. The local Cmax of gentamicin was reached after 0.5 hours (range, 0.5–1.0 hours) post-implantation in 5/6 dogs at a median concentration of 2053.3 µg/mL (range, 918.0–2791.9 µg/mL). Whitin 24 hours, the local concentration dropped below the MIC for Staphylococcus sp. (4 µg/mL) in 5/6 dogs. Plasma Cmax was achieved at a median of 1.2 hours post-implantation (range, 1.0–2.0 hours) and reached a median concentration of 10.3 µg/mL (range, 8.8–18.03 µg/mL). After 6 hours, the gentamicin concentration in the plasma was below 4 µg/mL in all dogs. The GICS provided a high local concentration of gentamicin in a short time with a local Cmax:MIC ratio of 513:1, largely sufficient to eliminate susceptible bacteria, including methicillin-resistant Staphylococcus pseudintermedius (MRSP) and Pseudomonas sp., in a clinical setting. The repeated administration of saline in the present study seemed to have induced a quicker gentamicin release from the GICS than described in previous studies that typically dealt with "drier" wounds.

Treatment with gentamicin-impregnated collagen sponges in reducing infection of implantable cardiac devices: 10-year analysis with propensity score matching

Introduction and ObjectivesThe incidence of device infection has increased over time and is associated with increased mortality in patients with cardiac implantable electronic devices (CIEDs). Gentamicin-impregnated collagen sponges (GICSs) are useful in preventing surgical site infection (SSI) in cardiac surgery. Nevertheless, to date, there is no evidence concerning their use in CIED procedures. Our study aims to determine the effectiveness of treatment with GICSs in preventing CIED infection. MethodsA total of 2986 adult patients who received CIEDs between 2010 and 2020 were included. Before device implantation, all patients received routine periprocedural systemic antibiotic prophylaxis. The study endpoints were the CIED infection rate at one year and the effectiveness of the use of GICSs in reducing CIED infection. ResultsAmong 1524 pacemaker, 942 ICD and 520 CRT implantations, CIED infection occurred in 36 patients (1.2%). Early reintervention (OR 9 [95% CI 3.180–25.837], p<0.001), pocket hematoma (OR 11 [95% CI 4.195–28.961], p<0.001), diabetes (OR 2.9 [95% CI 1.465–5.799], p=0.002) and prolonged procedural time (OR 1.02 [95% CI 1.008–1.034], p=0.001) were independent risk factors for CIED infection. Treatment with GICSs reduced CIED infections significantly ([95% CI −0.031 to −0.001], p<0.001). ConclusionsThe use of GICSs may help in reducing infections associated with CIED implantation.

Dressings and topical agents for the management of open wounds after surgical treatment for sacrococcygeal pilonidal sinus.

Dressings and topical agents for the management of open wounds after surgical treatment for sacrococcygeal pilonidal sinus.

Local Antibiotic Delivery Systems in Diabetic Foot Osteomyelitis: A Brief Review.

Diabetic foot osteomyelitis (DFO) is a severe, difficult to treat infection. Local antibiotic delivery has been studied as a potential therapeutic adjunct following surgery for DFO. This review aims to summarize the evidence on local antibiotic delivery systems in DFO. PubMed database was searched up to March 2020. Overall, 16 studies were identified and included: 3 randomized controlled trials (RCTs), 3 retrospective studies (RSs), and 10 case series. In the RCTs, gentamicin-impregnated collagen sponges significantly improved clinical healing rates and slightly improved duration of hospitalization. In the RSs, antibiotic-impregnated calcium sulfate beads non-significantly improved all healing parameters, but did not reduce post-operative amputation rates or time of healing. The majority of case series used calcium sulfate beads, achieving adequate rates of healing and eradication of infection. In conclusion, evidence for add-on local antibiotic delivery in DFO is still limited; more data are needed to assess this therapeutic measure.

First Description of a Mandibular Brodie Abscess in a Pediatric Patient: Case Report

Brodie abscesses can be considered to be a very rare condition, especially in pediatric patients. In 2019, the first cranial Brodie abscess was published in a 51-year-old female following a dental procedure. In this article, we present our case of a 13-year-old boy suffering from recurrent, painless swelling in the left mandibular molar region. MRI, CT, and histopathological examination revealed the diagnosis of a Brodie abscess. During the clinical course, several other differential diagnoses had to be excluded by CT, MRI, and histopathological examination, as a Brodie abscess was the by far least likely diagnosis. As no standard treatment protocols were available, we conducted a profound review of the current literature and the different therapeutic approaches described. The condition was subsequently treated by enucleation and implantation of a gentamicin-impregnated collagen sponge, accompanied by the administration of long-term oral antibiotics. In our postoperative aftercare, there was no clinical or radiological evidence for recurrence.

Efficacy of Antibiotic Laden Collagen Sponge In Treating Open Fracture

Introduction: Open fractures are known as a major predisposing factor for a higher incidence of infection. The aim of this study was to assess the efficacy of antibiotic impregnated collagen sponge in reducing the risk of infection in open fractures Grade 3. Materials and Methods: This was an observational cohort study, evaluating the incidence of infection in open fractures of the femur Grade 3A/3B following insertion of gentamicin impregnated collagen sponge (Collatamp®) during definitive fracture fixation. Eryhtrocyte Sedimentation Rate (ESR) and total white count (TWC) were used as blood parameters to observe for the possibility of infection from pre-operatively up to follow up visits at the clinic. Results: A total number of 36 patients, whom had sustained open fracture of the femur Grade 3A/B, underwent internal fixation with antibiotic impregnated collagen sponge insertion. Overall, ESR and TWC in both male and female gender were downgoing trend, with p values of &lt;0.001, and clinically there was no evidence of infection. No infection was identified in 97.2% of patients, following the internal fixation and antibiotic impregnated collagen sponge insertion. There was only one patient (2.8%) who developed infection following the definitive internal fixation and antibiotics impregnated collagen sponge insertion. Conclusion: The use of antibiotic impregnated collagen sponge in open fractures reduced the occurrence of infection. Furthermore, this allows for an uncomplicated union of the bone following definitive fixation.

THE EFFECTS OF GENTAMICIN-IMPREGNATED COLLAGEN SPONGE VERSUS GENTAMICIN-IMPREGNATED POLYMETHYLMETHACRYLATE BEADS IN PATIENTS WITH OSTEOMYELITIS

Objective: The usage of antibiotic-impregnated polymethylmethacrylate (PMMA) beads is regarded as the gold standard for local antibiotic delivery. However, the relatively new antibiotic-impregnated collagen sponge has multiple advantages over it. The objective of this study is to compare the measurable effects between gentamicin-impregnated collagen sponge and gentamicin-impregnated (PMMA) beads in patients with osteomyelitis.Methods: This is a case–control study which involved 60 patients who were diagnosed with osteomyelitis between January 2014 and June 2015, and underwent first surgical debridement with application of either gentamicin-impregnated collagen sponge (n=28) or gentamicin-impregnated PMMA beads (n=32). The numbers of debridement, trend of blood parameters, duration of hospitalization, and total duration of systemic antibiotic therapy needed to be completed were reviewed from the patients’ file.Results: A total of 53 patients of 60 were diagnosed with osteomyelitis of the lower limbs, while the remaining seven were involving the upper limbs. The gentamicin-impregnated collagen sponge group has significant lower reoperative rate (p&lt;0.05) and also significant reduction of total white cell count in 6 weeks (p&lt;0.05). The two groups showed no statistical difference in regard of duration of hospital admission, duration of systemic antibiotic therapy completed, and the reduction of C-reactive protein at 6 weeks post-debridement.Conclusion: This study reiterates the efficacy of gentamicin-impregnated collagen sponge that results in lower reoperative rate as compared to conventional gentamicin-impregnated PMMA beads.

A systematic review of local antibiotic devices used to improve wound healing following the surgical management of foot infections in diabetics.

Local antibiotics are used in the surgical management of foot infection in diabetic patients. This systematic review analyzes the available evidence of the use of local antibiotic delivery systems as an adjunct to surgery. Databases were searched to identify eligible studies and 13 were identified for inclusion. Overall, the quality of the studies was poor. A single trial suggested that wound healing is quicker when a gentamicin-impregnated collagen sponge was implanted at time of surgery, with no difference in length of stay or rate of amputation. Results from studies with high risk of bias indicated no change in wound healing when a gentamicin-impregnated sponge was implanted during transmetatarsal amputation, but a reduction in the incidence of wound breakdown (8% vs 25%, not statistically significant) was identified. A significant cost reduction was identified when using an antimicrobial gel to deliver antibiotics and anti-biofilm agents (quorum-sensing inhibitors) compared with routine dressings and systemic antibiotics. Analyses of case series identified 485 patients who were treated using local antibiotic delivery devices. The rates of wound healing, re-operation, and mortality were comparable to those that have been previously reported for the routine management of these infections. There is a lack of good-quality evidence to support the use of local antibiotic delivery devices in the treatment of foot infections in patients with diabetes. Cite this article: Bone Joint J 2018;100-B:1409-15.

Gentamicin-Impregnated Collagen Sponge: Effectiveness in Preventing Sternal Wound Infection in High-Risk Cardiac Surgery

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Intra-articular implantation of gentamicin impregnated collagen sponge causes joint inflammation and impaired renal function in dogs.

Gentamicin impregnated collagen sponge (GICS) can be used to treat intra-articular surgical site infections. High local concentrations of gentamicin can be reached for short periods; however the collagen vehicle may persist for much longer periods. We wished to determine the effect of sponge implantation on joint inflammation and renal function. Eighteen medium sized mixed breed research dogs of hound type were randomized to two groups; arthroscopic implantation of GICS at gentamicin dose = 6 mg/kg (n = 9) or sham operation (n = 9). Endpoints consisted of joint inflammation measured by synovial fluid cell counts and cytokine concentrations; lameness measured by force plate asymmetry indices; and renal function measured by glomerular filtration rate (GFR) study. The prevalence of lesions associated with aminoglycoside nephrotoxicity was assessed by renal biopsy and transmission electron microscopy. Gentamicin impregnated collagen sponge implantation caused joint inflammation (p <0.01), lameness (p = 0.04), and decreased GFR (p = 0.04). No difference was observed in the prevalence of renal lesions on biopsy between the treatment and control groups (p = 0.49). Gentamicin impregnated collagen sponge implantation causes joint inflammation and lameness as well as GFR reductions at the dose assessed. Gentamicin impregnated collagen sponge are not recommended for intra-articular implantation in dogs.

Cost analysis of gentamicin-impregnated collagen sponges in preventing sternal wound infection post cardiac surgery.

The use of antibiotic-impregnated sponges (Collatamp) during cardiac surgery is controversial. We analysed the cost-effectiveness of its selective use in patients at high-risk of sternal wound infection (SWI). Postoperative costs were analysed in two groups of patients undergoing heart surgery between 2011 and 2013: those with SWI (group 1) and in high-risk patients without SWI (group 2). The potential cost of gentamicin-impregnated collagen sponges (GCS) use in high-risk patients was compared with our current practice. We identified 1,251 patients with at least one recognised risk factor for developing SWI in this period. Of these, 18 developed SWI (incidence 1.4%). The median postoperative cost per patient without SWI was £9,617. The additional cost per patient incurred by SWI was £4,860.75. The annual additional cost for treating patients with SWI was £43,749. With a 50% reduction in SWI, the annual additional cost of treating these patients would be reduced to £21,873. The cost of GCS is £80 per patient. Adding this to £21,873 gives a potential total cost of £71,913 in the treated high-risk cohort. In our practice the annual cost of treating SWI in high-risk patients without use of GCS is lower than the annual cost of using GCS in all high-risk patients (£43,749 versus £71,913) if it produces a 50% reduction in SWI. The reduction in the incidence of SWI poses no economic benefit when the cost of the product is factored in.

Gentamicin-Impregnated Collagen Sponge: Effectiveness in Preventing Sternal Wound Infection in High-Risk Cardiac Surgery

Sternal wound infections represent one of the most frequent complications after cardiac surgery and are associated with high postoperative mortality. Several preventive methods have been introduced, and recently, gentamicin-impregnated collagen sponges (GICSs) have shown a promising effect in reducing the incidence of this type of complications. Gentamicin is an aminoglycoside antibiotic that has been widely used to treat infections caused by multiresistant bacteria; despite its effectiveness, its systemic use carries a risk of toxicity. GICSs appear to overcome this side effect, topically delivering high antibiotic concentrations to the wound and thus reducing the toxic-related events. Although several retrospective analyses and randomized controlled trials have studied the use of GICSs in cardiac surgery, conclusions regarding their efficacy in preventing sternal wound infection are inconsistent. We have reviewed the current literature focusing on high-risk patients.

The Use of Gentamicin-Impregnated Collagen Sponge for Reducing Surgical Site Infection after Spine Surgery.

ObjectiveSurgical site infection (SSI) is the one of the most frequent complications in hospitalized patients, and it extends hospital stays and causes extra morbidities. To reduce SSI after spine surgery, we applied the gentamicin-impregnated collagen sponge (Collatamp G) during the operation and analyzed the results retrospectively.MethodsBetween October 2012 and December 2015, we collected data who applied the Collatamp G in spine surgery at a single institution. Demographic data of patients and another possible risk factors of SSI were also included, and we assessed the correlation between the risk factors and the developing of SSI by reviewing electronic medical records retrospectively.ResultsThree percent of all patients (10 of 280) developed the SSI and only 0.8% of patients who applied Collatamp G developed SSI (1 of 119). Otherwise, 5% of patients who did not apply Collatamp G developed SSI (9 of 161) (p=0.034). We also analyzed the correlation between SSI and other potential risk factors but nothings showed statistical correlation with SSI.ConclusionIn this study, there were statistically significant results that SSI rate was decreased in the group of patients using Collatamp G in spine surgery generally. However, further studies are required to resolve some limitations in the future.

Scoring system to guide decision making for the use of gentamicin-impregnated collagen sponge to prevent deep sternal wound infection

The effectiveness of the routine retrosternal placement of a gentamicin-impregnated collagen sponge (GICS) implant before sternotomy closure is currently a matter of some controversy. We aimed to develop a scoring system to guide decision making for the use of GICS to prevent deep sternal wound infection. Fast backward elimination on predictors, including GICS, was performed using the Lawless and Singhal method. The scoring system was reported as a partial nomogram that can be used to manually obtain predicted individual risk of deep sternal wound infection from the regression model. Bootstrapping validation of the regression models was performed. The final populations consisted of 8750 adult patients undergoing cardiac surgery through full sternotomy during the study period. A total of 329 patients (3.8%) received GICS implant. The overall incidence of deep sternal wound infection was lower among patients who received GICS implant (0.6%) than patients who did not (2.01%) (P=.02). A nomogram to predict the individual risk for deep sternal wound infection was developed that included the use of GICS. Bootstrapping validation confirmed a good discriminative power of the models. The scoring system provides an impartial assessment of the decision-making process for clinicians to establish if GICS implant is effective in reducing the risk for deep sternal wound infection in individual patients undergoing cardiac surgery through full sternotomy.

Intra‐Articular Pharmacokinetics of a Gentamicin Impregnated Collagen Sponge in the Canine Stifle: An Experimental Study

To investigate local and systemic pharmacokinetics of gentamicin after intra-articular implantation of a gentamicin impregnated collagen sponge (GICS) in the inflamed canine joint. Descriptive repeated measures experimental study. Dogs (n = 9). Stifle joint inflammation was caused by urate injection. Twenty-four hours later a GICS (gentamicin dose, 6 mg/kg) was arthroscopically implanted. Synovial fluid and plasma gentamicin concentrations were measured for 14 days after implantation, and pharmacokinetic parameters modeled using statistical moment analyses. Intra-articular gentamicin concentrations fell to sub-MIC for Staphylococcus sp. (4 µg/mL) by 22.4 hours (95% CI: 18.6-26.2) after sponge implantation. Cmax synovial was 2397 µg/mL (95%CI: 1161-3634 µg/mL) at 1.2 hours (95%CI: 0.5-1.8 hours). Plasma gentamicin concentrations achieved levels of Cmax plasma = 8.0 µg/mL (95%CI: 6.1-10.0 µg/mL) at 1.5 hours (95%CI: 0.8-2.1) after GICS placement and fell below target trough of 2.0 µg/mL by 5.6 hours (95%CI: 4.7-6.5 hours) after GICS placement. Intra-articular gentamicin concentration after GICS placement at an IV-equivalent dose reached high levels and declined rapidly. The maximum plasma levels attained were ∼1/3 of the recommended sub-toxic target for people after parenteral gentamicin administration.

Application of gentamicin-collagen sponge shortened wound healing time after minor amputations in diabetic patients - a prospective, randomised trial.

IntroductionDiabetic foot infections are frequently polymicrobial. The lower tissue concentration of systemically administered antibiotics in diabetic patients was reported. Collatamp®EG (Syntacoll GmbH Saal/Donau, Germany) is a bioabsorbable, gentamicin impregnated collagen spongeused for local treatment. The aim of this randomized trial was to assess influence of gentamicin-collagen sponge applied to a wound on surgical outcomes after minor amputations in diabetic patients.Material and methodsFifty diabetic patients indicated for minor amputation in 2009 at our surgery department were included in the study. Patients were pre-operatively randomised into two groups. Twenty-five patients in group A were treated with gentamicin impregnated collagen sponge applied into wound peri-operatively while 25 patients in group B had minor amputation without gentamicin sponge.ResultsThere was no significant difference in the demographic data, procedures performed, diabetes duration and peripheral vascular disease severity between the groups. The median glycosylated haemoglobin was 6.0% (range: 4.6–9.5%) in group A and 6.2% (range: 4.0–8.4%) in control group B (non-significant). Median TcPO2 level was 44 (range: 13–67) in group A and 48 (range: 11–69) in control group B (non-significant). The median of wound healing duration in group A was 3.0 weeks (range: 1.7–17.1 weeks) compared to 4.9 weeks (range: 2.6–20.0 weeks) in control group B. This was with a statistically significant difference (p < 0.05).ConclusionsApplication of gentamicin impregnated collagen sponge shortened wound healing duration after minor amputations in diabetic patients by almost 2 weeks.

Gentamicin-impregnated collagen sponge for preventing sternal wound infection after cardiac surgery.

The frequency of sternal wound infection (SWI) after cardiac surgery ranges from 0.5% to 8% and is associated with significant morbidity, mortality, and treatment cost. Perioperative antibiotic prophylaxis is not sufficient to fully prevent the contamination of the surgical access site. One of the most effective methods for the prevention of wound infection seems to be the use of gentamicin-impregnated collagen sponge, which is successfully used in abdominal and orthopedic surgery. Surgically implantable topical antibiotics can reduce wound infection in cardiac patients as well, but the efficacy of SWI prevention in cardiac surgery still raises many questions.

Gentamicin-Collagen Implants to Reduce Surgical Site Infection

To determine whether gentamicin-impregnated collagen sponges (gentamicin-collagen implants) decrease the incidence of surgical site infection (SSI). SSIs cause substantial morbidity and increase the costs of healthcare. Antibiotic prophylaxis is a cornerstone of SSI reduction. Prophylactic local delivery of antibiotics with novel biodegradable drug carrier systems, such as the gentamicin-collagen implant, is a potential avenue for SSI reduction. Gentamicin-collagen implants have been previously assessed in multiple randomized controlled trials (RCTs) with conflicting results. Therefore, a systematic review and meta-analysis of all relevant RCTs was conducted to determine whether gentamicin-collagen implants reduce SSI. Major medical databases and trial registers were searched for published and unpublished RCTs. The endpoint of interest was the incidence of SSI. A random effects model was used and pooled estimates were reported as odds ratios (ORs), with the corresponding 95% confidence interval (CI). A subset analysis by incision type was planned a priori. Fifteen RCTs encompassing a total of 6979 patients were included in the final analysis. The included studies were of moderate to high quality. Gentamicin-collagen implants significantly reduced SSI [OR = 0.51; 95% CI: 0.33-0.77; P = 0.001; number needed to treat (NNT) = 21; I = 75%]. These results were seen in subset analysis of clean (OR = 0.53; 95% CI: 0.33-0.87; P = 0.01; NNT = 30) and clean-contaminated surgery (OR = 0.43; 95% CI: 0.20-0.93; P = 0.03; NNT = 9) specifically. Gentamicin-collagen implants decrease the rate of SSI.

EComment. Gentamicin-impregnated collagen sponge for high-risk cardiac surgery patients

I read with great interest the paper by Birgand et al. regarding the use of gentamicin-collagen sponges in closure of sternal wounds in high- risk cardiac surgery patients to reduce the incidence of deep sternal wound infections [1]. They conducted a single-centre prospective cohort study enrolling 552 high-risk patients for sternal wound infection. The primary end-point, which is reoperation for deep sternal wound infection, occurred in 40/298 (13.8%) in the group without the antibiotic implants and in 22/175 (12.6%) in the treated group with the gentamicin-collagen sponges. The authors concluded that gentamicin-collagen sponges are not effective in preventing deep sternal wound infections in high-risk patients undergoing cardiac surgery. Gentamicin-collagen sponges were introduced in 1985 for the prevention of surgical site infection and they are mainly used after laparotomy [2]. However, there is no consensus about their use in patients undergoing cardiac surgery [3]. A recently-published review of the literature and a meta-analysis showed conflicting results. A best evidence topic in cardiac surgery concerning the use of gentamicin-collagen sponges to reduce wound infections was recently published in this journal [4]. The authors of this paper concluded that the use of this implant did not reduce the incidence of sternal wound infection in high-risk patients after cardiac surgery. Recently, a meta-analysis of randomized controlled trials was performed by Mavros et al [5]. Four randomized controlled trials were included in this meta-analysis. All 4 trials were considered of high quality (score of 3 or more according to the modified Jadad criteria). By pooling data provided by 4 published trials (4672 patients), gentamicin-collagen sponge use demonstrated a significant reduction in the rate of deep sternal wound infection (RR, 0.62; 95% CI, 0.39-0.97; P =0.04). Regarding the incidence of superficial sternal wound infection, gentamicin-collagen sponges use seemed to add no benefit (RR, 0.65; 95% CI, 0.34- 1.25; P =0.20). Therefore, in view of the clinical implications of their findings from this meta-analysis, the authors suggest that routine prophylactic retrosternal placement of gentamicin-impregnated sponges reduces the incidence of deep sternal wound infection. The implementation of this simple measure could bring particular benefits in high-risk patients. With the purpose of elaborating consensus guidelines for the best management of these high-risk patients, and to draw definitive conclusions, future studies with larger numbers of patients are required. Conflict of interest: none declared

EComment. Accuracy of all reference citations

I read with interest and a lot of attention the article by Birgand et al. regarding the results of their quasi-experimental single-centre prospective cohort study related to the efficacy of gentamicin-impregnated collagen sponges in preventing deep sternal wound infections in high-risk cardiac surgery patients [1]. I would greatly appreciate it, if the authors could explain the relation of their first reference by Barennes et al. to their very well presented data [2]. According to the International Committee of Medical Journal Editors, readers should be provided with direct references to original research work whenever possible. There is no need for large numbers of references. Small numbers of references to key or pivotal original articles often provide the appropriate volume of information [3]. In addition, citation errors sometimes appear in the published version of articles inadvertently [3]. Conflict of interest: none declared