Safety and effectiveness of a drug-loaded haemostatic sponge in chronic rhinosinusitis: a randomized, controlled, double-blind study.

Some cases of chronic rhinosinusitis (CRS) require surgical treatment and postoperative nasal packing, but bleeding and adhesion are common complications after nasal surgery. Biodegradable drug-loaded implants hold great therapeutic options for the treatment of CRS, but little data are available regarding the safety and efficacy of a novel drug-loaded haemostatic sponge (DLHS) in the sinus. The aim of this study was to investigate the safety and efficacy of DLHS in the sinus. We conducted a prospective, randomized, controlled, double-blind clinical trial. In this clinical trial, 49 patients were enrolled and randomly divided into 2 groups: group A (n = 25) had the DLHS containing 1 mg budesonide and 0.67 mg sodium hyaluronate placed into the sinus, and group B (n = 24) had the Nasopore placed after ESS. Endoscopic follow-up was performed for 12 weeks, and the findings were classified using the discharge, inflammation, polyps/oedema (DIP) endoscopic appearance scores. All patients completed questionnaires to evaluate their sinonasal symptoms by using the sinonasal outcome test-22 (SNOT-22) Chinese version and visual analogue scale (VAS). Serum cortisol concentration in group A was measured prior to surgery and at days 1, 3, 7, and 14 after nasal surgery. Comparing group A and group B, at 2 weeks, no significant differences were observed in either objective or subjective parameters. The mean value of VAS for rhinorrhoea and DIP for oedema and the mean value of nasal adhesion were significantly lower in Group A than in Group B at 6 and 12 weeks, but a significant difference did not occur in SNOT-22 and VAS for dysosmia between the two groups at 6 and 12 weeks. The mean serum cortisol concentrations in group A at the follow-up were within normal limits without remarkable fluctuations. This study demonstrates the safety and efficacy of a novel biodegradable DLHS with the possibility of being used in CRS patients, and this sponge may reduce inflammation and minimize adhesions via controlled local drug delivery without measurable systemic exposure.

Surgical removal of the largest transgastric migrated gossypiboma: A case report.

RATIONALE: Gossypiboma is a term that refers to the condition of accidentally retained surgical gauze after surgeries. While many manifestations and complications are possible in this case, the migration of the retained gauze into the gastric cavity is one of the rarest. In this paper, we report the largest migrated surgical towel to the gastric cavity in the literature, measuring 90 cm × 90 cm. PATIENT CONCERNS: A 33-year-old woman with recurrent epigastric pain unresponsive to treatment was referred to our hospital. She had undergone an open surgery cholecystectomy 11 years before admission during wartime in Syria. DIAGNOSES: Abdominal computed tomography with contrast showed a large mass in the stomach, indicating malignancy. However, upper gastrointestinal endoscopy revealed a gray-black foreign body occupying the entire gastric lumen, which indicated the presence of bezoar. Upon surgery, the final diagnosis of gastric gossypiboma was made; which was a retained surgical towel from the previous cholecystectomy that had fully migrated to the stomach and resembled both malignancy and bezoar upon investigation. INTERVENTIONS: The patient underwent open surgery to excise the foreign body. OUTCOMES: The gossypiboma was successfully removed, and the patient was discharged 5 days after the operation without complications. LESSONS: Retained surgical items, such as gossypiboma, can lead to significant medical complications. The migration of gossypiboma to the stomach, though rare, poses challenges in diagnosis and management, often requiring open surgical removal to prevent adverse outcomes. Early detection and intervention are crucial to avoiding associated morbidity and mortality. It is important to consider gossypiboma in patients with unexplained abdominal pain following surgery and to emphasize meticulous sponge counting to prevent this complication.

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.

Improved nasal trumpet: "In-house" device to promote the healing of skin grafts in the anterior nasal nostril.

This technical note addresses the complexities of reconstructive surgery for malignant skin lesions in the lower nasal aperture and pericolumellar region. Traditional solutions, such as free skin grafts, face challenges in maintaining attachment to the surgical site without adequate support. Nasal packing, a common approach, obstructs the nasal opening and compromises air passage, hindering ventilation. The use of a nasal trumpet has proven beneficial in maintaining nasal patency in various cases, but it falls short of addressing the specific challenges posed by reconstructive surgery. The proposed solution involves a novel device comprising a nasal cannula, surgical sponge, and fine mesh gauze with 3% bismuth tribromophenate. This combination serves a triple purpose: the nasal cannula facilitates air passage, the surgical sponge applies controlled pressure around the nasal opening to aid graft adhesion, and the gauze with bismuth tribromophenate promotes wound healing and prevents infection. The assembled device is inserted into the nostril, anchored to the patient's skin with silk stitches. This innovative approach offers a practical solution for maintaining nasal patency, promoting graft adherence, and supporting wound healing in reconstructive surgery.

Endoluminal Vacuum Therapy Using a New "Fistula Sponge" in Treating Defects of the Upper Gastrointestinal Tract-A Comparative, Retrospective Cohort Study.

Background and Objectives: Anastomotic insufficiencies (AI) and perforations of the upper gastrointestinal tract (uGIT) result in high morbidity and mortality. Endoscopic stent placement and endoluminal vacuum therapy (EVT) have been established as surgical revision treatment options. The Eso-Sponge® is the only licensed EVT system with limitations in treating small defects (<10 mm). Therefore, a fistula sponge (FS) was developed for the treatment of such defects as a new therapeutic approach. The aim of this study was to evaluate both EVT options' indications, success rates, and complications in a retrospective, comparative approach. Materials and Methods: Between 01/2018 and 01/2021, the clinical data of patients undergoing FS-EVT or conventional EVT (cEVT; Eso-Sponge®, Braun Melsungen, Melsungen, Germany) due to AI/perforation of the uGIT were recorded. Indication, diameter of leakage, therapeutic success, and complications during the procedure were assessed. FSs were prepared using a nasogastric tube and a porous drainage film (Suprasorb® CNP, Lohmann & Rauscher, Rengsdorf, Germany) sutured to the distal tip. Results: A total of 72 patients were included (20 FS-EVT; 52 cEVT). FS-EVT was performed in 60% suffering from AI (cEVT = 68%) and 40% from perforation (cEVT = 32%; p > 0.05). FS-EVT's duration was significantly shorter than cEVT (7.6 ± 12.0 d vs. 15.1 ± 14.3 d; p = 0.014). The mean diameter of the defect was 9 mm in the FS-EVT group compared to 24 mm in cEVT (p < 0.001). Therapeutic success was achieved in 90% (FS-EVT) and 91% (cEVT; p > 0.05). Conclusions: EVT comprises an efficient treatment option for transmural defects of the uGIT. In daily clinical practice, fistulas < 10 mm with large abscess formations poses a special challenge since intraluminal cEVT usually is ineffective. In these cases, the concept of extraluminal FS placement is safe and effective.

Gossypiboma larynx: a rare cause of post-tracheostomy stridor-case report and review of literature.

BACKGROUND: Gossypiboma, a retained surgical sponge with a foreign body reaction, is an unusual but serious complication seen in open abdominal surgeries. It is exceptionally rare following head and neck surgeries. Here, we present a case of Gossypiboma of the upper airway following tracheostomy. CASE PRESENTATION: A 32-year-old male presented with stridor and difficulty breathing one-month post-tracheostomy after a severe head injury following a road traffic accident. A neck radiograph was unremarkable, and a computed tomography (CT) scan of the neck showed a well-defined homogenous curvilinear membrane extending from the hypopharynx to the upper trachea. Bronchoscopic evaluation of the larynx and upper trachea revealed a retained surgical sponge, which was retrieved. The patient's breathing improved drastically post intervention. CONCLUSION: Gossypiboma may go undetected in radiographs and may also present atypically as a homogenous membrane on a CT scan of the neck. Though rare, retained surgical items can have profound medicolegal and professional consequences on physicians. Hence, a strong clinical suspicion and vigilance for gossypiboma is necessary for patients presenting with respiratory distress post-tracheostomy.

Diaphragm reconstruction using a TachoSil patch as alternative to intrasellar packing for small focal diaphragm defects in pituitary surgery: a cohort study.

BACKGROUND: During pituitary surgery, CSF leaks are often treated by intrasellar packing, using muscle or fat grafts. However, this strategy may interfere with the interpretation of postoperative MRI and may impact the quality of resection in cases of second surgery, due to the existence of additional fibrous tissue. We present an alternative technique, using a diaphragm reconstruction with a heterologous sponge combining fibrinogen and thrombin (TachoSil), applied in selected patients with low-flow CSF leaks. This study investigates the surgical outcome of patients treated with this strategy. METHODS: From a cohort of 2231 patients treated from June 2011 to June 2023 by endoscopic endonasal approach for pituitary surgery, the surgical technique of diaphragm repair with TachoSil patch performed in 55 patients (2.6%) was detailed, and the rate of closure failure was analyzed at 6 months postoperatively. No intrasellar packing was used and sellar floor reconstruction was performed whenever possible. The rate of postoperative CSF leak was compared with that reported in three previous publications that also used the TachoSil patch technique. RESULTS: Patients were mostly women (F/M ratio: 1.2) with a median age of 53.6 years. Surgery was indicated for non-functioning adenomas, Cushing's disease, acromegaly, and Rathke's cleft cysts in 38/55 (69.1%), 6/55 (10.9%), 5/55 (9.1%) and 6/55 (10.9%) patients respectively. The rate of postoperative CSF leak was 1.8% (n = 1/55), which was not significantly different from that reported in the three cohorts from the literature (2.8%, p > 0.05). No postoperative meningitis was recorded. CONCLUSIONS: In highly selected patients with low-flow CSF leaks related to small focal diaphragm defects, diaphragm reconstruction using a TachoSil patch can be a safe and valuable alternative to intrasellar packing.

Comparison of Polyvinyl Alcohol Sponge and Gauze Packing for Nasal Fracture Treatment: An Efficacy and Safety Analysis.

Nasal fractures are commonly treated using nasal packing as an internal splint after performing closed reduction. Although gauze and polyvinyl alcohol sponge (PVAS) are both commonly used for packing, few reports have compared their efficacy and safety in nasal fracture treatment. Therefore, in this study, the authors, aimed to retrospectively compare the efficacy and safety of gauze packing in 208 patients and PVAS packing in 225 patients who underwent closed reduction at our hospital. The proportions of patients requiring revision surgery did not differ significantly between the PVAS and gauze groups ( P =0.627). However, in comparison to the gauze group, the PVAS group displayed significantly fewer instances of uncontrolled epistaxis following packing removal, as well as fewer occurrences of dropout and loss of packing ( P =0.023, P =0.007, and P <0.001, respectively). The results of logistic regression analysis adjusted for confounding factors also showed that compared with the gauze group, the PVAS group was significantly less likely to experience packing dropout (odds ratio=0.13; 95% confidence interval, 0.06-0.29, P <0.001) for which younger and older age and allergic rhinitis were independent risk factors. In conclusion, both gauze and PVAS are effective packing materials as internal splints after closed reduction of nasal bone fractures. Specifically, PVAS utilization warrants consideration in pediatric and geriatric populations, individuals with allergic rhinitis, and those at elevated risk of bleeding.

Computed tomography of a canine omental torsion secondary to a chronic abdominal gossypiboma and concurrent incidental broad ligament torsion.

A 5-year-old female spayed Dogue de Bordeaux was referred for concerns of an abdominal mass and peritoneal effusion. Abdominal radiographs identified a mid-ventral abdominal soft tissue opaque mass containing a radiopaque marker consistent with a gossypiboma. Contrast-enhanced abdominal CT identified two whirl signs associated with the abdominal gossypiboma. Exploratory laparotomy confirmed an omental torsion with encapsulated gossypiboma and concurrent incidental torsion of the remnant of the right broad ligament. Based on a literature review, omental torsions are an unreported complication of gossypibomas in canids.

Ultrasonographic appearance of retained surgical sponges and gauzes in the acute postoperative period: a phantom and cadaveric study.

Retained surgical sponges or gauzes (RSS) are an uncommon complication of exploratory laparotomy surgery and pose a clinically significant risk to the patient. The purpose of this two-part, prospective, descriptive study was to describe the previously uncharacterized ultrasonographic appearance of RSS in phantom and cadaveric models of the acute postoperative period (24-48 h). For the first part of the study, a gelatin phantom containing a woven gauze with a radiopaque marker (radiopaque gauze), a woven gauze with no marker (nonradiopaque gauze), and a laparotomy sponge with a radiopaque marker (radiopaque sponge) was evaluated with ultrasonography. For the second part of the study, a total of 23 gauzes and sponges (of the aforementioned three types) were placed within the peritoneal cavity of 20 cadavers in one of three randomized locations during an exploratory laparotomy laboratory. The cadavers were imaged with ultrasonography 17 h later and still images and video clips were reviewed. The retained surgical sponges and gauzes in the gelatin phantom displayed multiple hyperechoic layers and variable degrees of distal acoustic shadowing. In cadavers, 100% (23/23) of the retained surgical sponges and gauzes displayed a single hyperechoic layer of variable thickness and distal acoustic shadowing. In 95.6% (22/23) retained sponges and gauzes, there was a thin hypoechoic layer noted superficially to the hyperechoic layer. An improved understanding of the ultrasonographic appearance of retained sponges or gauzes in the acute postoperative period may assist in the identification of these objects.

Preventable morbidities of a successful intervention, Textiloma/Gossypiboma: A case series.

Preventable morbidities are serious conditions that have the potential to cause serious harm or death of the patient. One of the preventable morbidities is Gossypiboma or involuntary leaving of surgical sponge inside the body. The implication for the patient and the surgeon is grave. Gossypiboma is preventable if guidance and safety recommendations are followed. The purpose of presenting this case series is to rekindle awareness of the phenomena of Gossypiboma, highlight the implications, and stress prevention. Data of patients presented in the Lahore General Hospital was collected, which includes their demographic, clinical features, and management outcome. Their age, gender, surgery conducted, onset of symptoms, and salvage procedure were noted. Five cases are included in this case series from which it was concluded that Gossypiboma is encountered most commonly after intra-abdominal operation. Women are at increased risk during obstetric and gynaecological operations, though both genders are affected.

Gossypiboma: An uncommon but avoidable dreadful complication.

Gossypiboma or retained surgical sponge in abdominal cavity is an avoidable complication which has wide variety of clinical presentations and associated medico-legal issues as well. The incidence is under-reported. Pre-operative diagnosis is difficult and management is surgical. We present a case of gossypiboma in a male with multiple vesico-cutaneous and colo-vesical fistulae.

Gossypiboma as a Rare Cause of Small Bowel Obstruction: A Case Report.

Unintentionally retained textile foreign bodies in the abdomen after laparotomy is a serious medical error, with unknown incidence which can lead to severe complications. We present the case of a 24-year-old woman with a retained surgical sponge migrated into the jejunal lumen and causing an intestinal obstruction. Removal of the foreign body required repeated laparotomy and segmental resection of the affected intestinal loop. The article provides the analysis of the imaging diagnostic results, as well as possible reasons that led to the foreign body being left unintentionally. Reliable reduction of incidence and severity of consequences after retention of textile surgical objects in the abdomen can only be achieved through improved standards of patient safety, including careful sponge counting and the routine use of materials with radiopaque markers.

ST2 deletion accelerates inflammatory-angiogenesis and remodeling in subcutaneous implants in mice.

Implantation of biomedical/synthetic devices to replace and/or repair biological tissues very often induces an adverse healing response (scarce angiogenesis, excessive collagen deposition) which is detrimental to implant functionality and integration to host tissue. Interleukin-33/ST2 axis (IL-33/ST2) has been shown to modulate angiogenic and remodeling processes in several types of injuries. However, its effects on these processes after implantation of synthetic matrix have not been reported. Using synthetic matrix of polyether-polyurethane implanted subcutaneously in mice lacking ST2 receptor (ST2/KO), we characterized neovascularization and matrix remodeling in the fibrovascular tissue induced by the implants. Tissue accumulation was increased inside and around the implants in KO implants relative to the wild type (WT). More intense proliferative activity, using CDC 47 marker, was observed in KO implants compared with that of WT implants. Angiogenesis, using two endothelial cell markers, Von Willebrand Factor (VWF) and vascular endothelial cell VE cadherin and hemoglobin content, increased in implants of KO mice relative to control WT. Remodeling of the newly formed fibrovascular tissue (soluble collagen and PicroSirius Red-stained histological sections) showed predominance of type 1 collagen in ST2-KO implants versus type 3 in control implants. The number of positive cells for caspase-3, apoptotic marker, decreased in ST2 group. Our findings evidenced a role of IL-33/ST2 axis in restraining blood vessel formation and regulating the pattern of matrix remodeling in the fibrovascular tissue induced by synthetic implants. Intervention in this cytokine complex holds potential to accelerate integration of biomaterial and host tissue by improving blood supply and matrix remodeling.

Gentamicin-Containing Collagen Implant May Reduce Surgical Site Infections After Open Infrainguinal Arterial Revascularization.

BACKGROUND: Deep-space surgical site infections carry significant morbidity and mortality. The evidence for gentamicin-containing collagen implants at reducing surgical site infections in open infrainguinal arterial surgery is limited. This study examined whether gentamicin-containing collagen implants reduces 30-day surgical site infections and their severity following open infrainguinal arterial surgery. METHODS: A retrospective observational cohort study that included all patients undergoing infrainguinal arterial bypass or endarterectomy between November 2015 and March 2019 at a single tertiary vascular unit. Patients with contaminated/infected surgical fields, surgical wounds treated with negative pressure therapy, or the usage of antimicrobial implants and dressings other than Collatamp GⓇ (Aralez Pharmaceuticals, Canada) were excluded. Patients with gentamicin-containing collagen implants placed abutting vasculature were compared against patients without gentamicin-containing collagen implants. Outcomes included the rate of surgical site infections and their severity within 30 days after the operation. RESULTS: In 159 procedures (mean age 67.7 years, 74.8% male, 33.3% diabetic, 16.4% chronic renal failure, 25.2% anticoagulated postoperatively, 32.7% with prosthetic implants), 55 (34.6%) procedures received gentamicin-containing collagen implants. There were significantly more males (85.5% vs. 69.2%; P = 0.025), higher rates of obesity (41.8% vs. 26.0%; P = 0.041), and hyperlipidemia (65.5% vs. 49.0%; P = 0.048) in the gentamicin-containing collagen implant group. In total, 6 (3.8%) procedures developed deep-space surgical site infections (1 with gentamicin-containing collagen implant, 5 without) and 13 (8.2%) had severe surgical site infections that required re-intervention (1 with gentamicin-containing collagen implant, 12 without). On logistic regression analysis, the absence of gentamicin-containing collagen implants statistically significantly increased the odds of overall surgical site infections (OR = 2.50; 95% CI 1.01 - 6.19; P = 0.047). There was no statistically significant difference in the odds of deep-space surgical site infections or the severity and need for reintervention of surgical site infections. CONCLUSIONS: This is the first study that examined the effect of gentamicin-containing collagen implants on the severity of surgical site infections in vascular surgery. Gentamicin-containing collagen implants may reduce the odds of overall surgical site infections. It did not reduce the odds of deep-space surgical site infections or the severity and reintervention rate of surgical site infections following infrainguinal arterial revascularization. Larger studies are required to achieve adequate power to assess for these outcomes.