With and without exogenous biological scaffolds for repairing traumatic perforations of tympanic membrane: Randomized clinical trials.

OBJECTIVE: The objective of this study was to compare the efficacy of ofloxacin ear drops, vaseline gauze (VG) and dry gelfoam alone on the large traumatic perforations of tympanic membrane (TM). MATERIAL AND METHODS: A randomized prospective analysis was performed for the treatment of traumatic perforation larger than 25 % of the entire TM. The closure rate, closure time, and hearing gain between ofloxacin ear drops, VG and gelfoam alone groups were compared at 3 months. RESULTS: Final analysis was performed on 70 patients. The closure rates of perforation in the ofloxacin ear drops, VG, and dry gelfoam patch groups were 100.0 %, 92.0 %, and 87.5 %, respectively (P = 0.41).The mean closure times were 8.67 ± 3.1, 10.65 ± 4.2, and 14.33 ± 7.5 days for the ofloxacin ear drops, VG, and gelfoam patch alone groups, respectively. The closure times among the 3 groups were significantly different (P = 0.003). In addition, there was a significant difference between the ofloxacin ear drops and gelfoam patch alone groups with regard to closure time (P = 0.003), while there was no significant difference between the ofloxacin ear drops and VG groups (P = 0.080) or VG and gelfoam patch groups (P = 0.056).The mean hearing gain was 11.4 ± 2.3 dB for the ofloxacin ear drops group, 11.7 ± 4.1 dB for the VG group, and 12.2 ± 1.6 dB for the gelfoam patch group (P = 0.69). CONCLUSIONS: The repairing of traumatic perforations didn't require an exogenous biological scaffold. Ofloxacin ear drops and VG were a deal material for repairing traumatic perforation in otology clinic, which not only was readily available and inexpensive but also showed faster closure compared with dry gelfoam alone.

Efficacy of gelfoam middle ear packing in type-1 tympanoplasty: systematic review and meta-analysis.

PURPOSE: To conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) that evaluated the surgical outcomes of type-1 tympanoplasty with and without gelfoam middle ear packing. METHODS: PubMed, CENTRAL, Scopus, Web of Science, and Google Scholar databases were screened from inception until October 2022. The included RCTs were evaluated for risk of bias, and the quality of each outcome was assessed according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. RESULTS: Nine RCTs with 773 participants (gelfoam = 381 and non-gelfoam = 392) were analyzed. The overall study quality varied: low risk (n = 4 RCTs), some concerns (n = 3 RCTs), and high risk (n = 2 RCTs). There were no significant differences between both arms regarding the graft uptake rate (moderate certainty), hearing improvement rate (moderate certainty), type of impedance audiometry (moderate certainty), and ear discharge (low certainty). The mean change in air-bone gap was significantly higher in the non-gelfoam arm compared with the gelfoam arm (low certainty). However, the non-gelfoam group had superior hearing improvement in only the early postoperative period (i.e., one month); however, after two, three, and six months, there were no significant differences between both arms. The rate of ear fullness was significantly higher in the gelfoam arm compared with the non-gelfoam arm (moderate certainty). CONCLUSION: Among patients undergoing type-1 tympanoplasty, the surgical outcomes did not significantly differ between both arms. The practice of middle ear packing with gelfoam needs to be standardized.

Effect of middle ear gelfoam on hearing and healing process after tympanoplasty: A prospective randomized case-control study.

PURPOSE: This prospective randomized case-control study was performed to compare the surgical outcomes of our swing-door overlay tympanoplasty with or without absorbable gelatine sponge (AGS, gelfoam) packing in the middle ear cavity, according to the surgical procedure. METHODS: Fifty-seven patients who underwent swing-door overlay tympanoplasty by a single surgeon were enrolled in the study. The data of 30 patients of the gelfoam-packing group (GPG) and 27 patients of the non-gelfoam-packing group (NGPG) were prospectively collected and compared. RESULTS: Closure of the tympanic membrane was found to be successful in all patients at postoperative 3 months evaluation. NGPG showed a statistically better healing process compared to GPG; earlier epithelialization and less fascia edema in NGPG than in GPG (P < 0.05). The air-bone gap (ABG) measured at postoperative 1 and 2 months was smaller in NGPG than GPG, although there were no statistical differences. CONCLUSION: This study revealed earlier healing process and faster recovery of ABG in NGPG, thereby indicating that the gelfoam in the middle ear may interfere with both hearing recovery and the healing process of neodrum.

Composite gelfoam/fascia graft: a novel technique in tympanoplasty surgery.

BACKGROUND: Traditional tympanoplasty techniques require graft placement and then supporting material (GelFoam) as a two-step process. Both steps potentially disrupt accurate graft placement leading to failure and persistence of the perforation. METHODS: We demonstrate a novel technique for graft preparation and placement using composite gelfoam/fascia in which the gelfoam and fascia are compressed into a common layer and applied to the perforation and drum remnant in a single step. Placement is ergonomically efficient and effective. CONCLUSION: This novel modification of traditional graft preparation and placement is simple and ergonomically efficient.

Percutaneous ultrasound-guided plugged liver biopsy - a single-centre experience.

BACKGROUND: Liver biopsy is a widely used, safe diagnostic tool utilised by clinicians for the histopathological assessment of the liver. Our study aims to report our experience in patients who underwent ultrasound-guided plugged percutaneous liver biopsy in a tertiary care hospital in India. MATERIAL AND METHODS: The Institutional Ethical Review Board approved this retrospective study, and informed consent was obtained from all the patients. A total of 830 liver biopsies were performed between January 2014 and December 2018, of which 782 were plugged percutaneous liver biopsies. The tract was plugged using Gelfoam slurry. Various observations related to the procedures were recorded. RESULTS: Seven hundred and eighty-two were plugged percutaneous liver biopsies, which were performed during the study period. Of the 782 patients, 163 were male, and 619 were female (20.8 % and 79.2 %, respectively), with a mean age of 49.6 ± 2 years (1 month to 86 years). A 100% technical success rate was seen. No immediate major complications were documented in any of the patients who underwent plugged biopsies. No significant complications were seen in any patient. CONCLUSIONS: Percutaneous liver biopsy is an extensively performed diagnostic tool. We found that ultrasound-guided percutaneous plugged liver biopsy is an easy to perform procedure, which is associated with a lower risk of a bleeding complications.

Comparison of functional outcomes of cartilage tympanoplasty with silastic sheet versus Gelfoam packing in middle ear.

BACKGROUND AND AIM: Tympanoplasty is a common surgery in otorhinolaryngology field. In majority of procedures, in addition to the graft used for closure of tympanic membrane, a packing material is essential to be placed in the middle ear cavity. The main goals of packing can be summarized as providing support to the tympanic membrane and ossicular grafts, aeration of middle ear cavity and hemostasis. Several packing materials are currently available for using in middle ear surgeries. Each agent is associated with particular advantages and disadvantages, so choosing the proper packing agent is essential in tympanoplasty surgeries. In this study we aimed to compare two common packing materials (Gelfoam and silastic sheets) in cartilage tympanoplasty surgeries. METHODS AND MATERIALS: In this block-randomized clinical trial, 78 patients undergoing tympanoplasty in Vali-e-asr hospital in 2017 and 2018 were enrolled. They were randomly assigned to silastic sheet or gelfoam groups. The functional outcomes were compared between the groups. Statistical analysis was performed by SPSS. RESULTS: Success was achieved in 32 (82.1%) patients and 34 (87.2%) patients in gelfoam and silastic sheets' groups, respectively (p = 0.530). The perforation area percentage was significantly lower (P = 0.007) in Gelfoam group. The other parameters were statistically the same in both groups (P > 0.05). CONCLUSION: Overall, Gelfoam and silastic sheet methods had similar efficacy in cartilage tympanoplasty. Using each method depends on the preferrence of surgeon and patients' characteristics. Multi-center studies with larger sample sizes are needed for more conclusive results.

Impact of perforation size and predictive factors for successful pediatric gelfoam myringoplasty.

OBJECTIVES: Rates of success with pediatric myringoplasty range from 35 to 95%. The objective of this study is to evaluate the impact of perforation size on successful closure of the tympanic membrane (TM) after gelfoam myringoplasty. We also aim to identify variables that affect perforation closure rates and define predictive factors for successful TM closure. METHODS: A retrospective chart review of all patients that underwent gelfoam myringoplasty by a single surgeon from August 2008 through January 2015 was performed. RESULTS: One hundred fifty-nine patients met inclusion criteria and underwent a total of 219 procedures. Overall, gelfoam myringoplasty had an 83.1% rate of successful closure. Average perforation size was 15.31%. Classification tree analysis separated our cohort into three groups based on perforation size: Group 1 (<16.25%) had a 91% closure rate, group 2 (16.25% to <31.25%) had a 66.0% closure rate and group 3 (≥31.25%) had a 30.0% closure rate. Smaller perforations (P ≤0.001) were associated with increased success rates. Other factors associated with successful closure of the TM included younger age at the time of myringoplasty (P ≤0.001), fewer number of prior tympanostomy tubes (P = 0.016), and lesser duration of tube retention (P = 0.003). CONCLUSION: Gelfoam myringoplasty provides good overall TM closure rates and may be considered as a potential first-line option for repair of perforations, including those involving up to 40% of the TM. Younger patients with smaller perforations, fewer sets of tubes, shorter length of tube retention are more likely to have successful closure of the tympanic membrane.

Clinical Implications of Poloxamer 407 as Packing Material in an Animal Model.

BACKGROUND: Endoscopic ear surgery has recently increased, but it is still inconvenient and time-consuming to place packing material in the middle ear with one hand. Poloxamer 407 (P407) is a thermo-reversible gel that can be easily administered with one hand into the middle ear cavity in liquid form. Upon warming to body temperature, the gel form of P407 can support the graft in the target position and is known to prevent postsurgical tissue adhesion. OBJECTIVES: We aim to investigate the feasibility of P407 as packing material in an animal model. Male Hartley guinea pigs (350 and 400 g) were utilized in this study. METHOD: The animals were randomly divided into 3 groups according to the packing material: the control group, the P407 group, and the gelatin group. To assess the role of packing material on bacterial colonization, left ears were inoculated with Streptococcus pneumoniae through the tympanic membrane using a 0° endoscope. Five days after inoculation, the middle ear cavity was packed through a transbullar approach using 18% P407 or gelatin in both ears. In the control group, no ear pack was inserted. The tympanic membrane was examined every week using a 0° 1.9-mm endoscope until 6 weeks. Half of the animals in each group were sacrificed 6 weeks after placement of the packing materials. RESULTS: Compared with the absorbable gelatin sponge, the P407 group showed little inflammation or fibrosis in the tympanic membrane and middle ear mucosa regardless of bacterial inoculation. The gelatin group showed severe otorrhea or perforation until 2 weeks in the right ear (2 of 4) and the left ear (1 of 4). Even though the endoscopic findings were similar between both packing groups at 6 weeks, histological analysis showed persistent packing material, inflammatory cells, and fibrosis in the gelatin group compared to the P407 group. CONCLUSIONS: This study suggested that P407 is feasible as a packing material to handle with one hand and to prevent adhesion, especially in infected middle ear mucosa. Although there is a lack of data on how well P407 supports grafts, we suggest that P407 could be a candidate for packing material in endoscopic ear surgery.

Factors affecting the treatment outcomes of myringoplasty in patients with small tympanic membrane perforations.

PURPOSE: Factors affecting the outcomes of myringoplasty have been widely discussed but remain controversial. In this study, we retrospectively analyzed the factors associated with the outcomes of myringoplasty treating small tympanic membrane perforations (defined as those involving less than 30% of the whole eardrum area) in patients with a history of chronic otitis media. METHODS: The clinical demographic data, preoperative pure tone audiometry, surgical procedures, and surgical outcomes of patients with small tympanic perforations were analyzed statistically. Overlay myringoplasty was performed in 24 ears (45.27%); Gelfoam® plugs were placed in 29 ears (54.73%). Univariate and multivariate tests among demographic, surgical procedure-related, hearing test-related factors were performed. RESULTS: A total of 53 patients (22 males and 31 females) were enrolled (mean age 54.84 ± 15.51 years). Fourteen patients (26.41%) had the habit of cigarette smoking, 8 (15.09%) had diabetes mellitus, 20 (37.73%) had a past history of chronic otitis media, 5 (9.43%) had a history of grommet insertion, 5 (9.43%) had received radiotherapy in the head and neck region, and 1 (1.88%) had microtia. The success rate for overlay myringoplasty using Silastic® sheets was 54.16%; the success rate for Gelfoam® plugs was 54.16%. On univariate analysis, smoking, older age, and the mean air conduction and bone conduction hearing levels significantly affected the surgical outcomes. Cigarette smoking was the only independent (negative) prognostic factor of surgical success on multivariate analysis (OR  = 0.1614, 95% CI: 0.0336-0.7762, p = 0.0228). CONCLUSION: As for surgical repair for the small tympanic membrane perforations with a history of chronic otitis media, age, cigarette smoking, mean air conduction threshold, and mean bone conduction threshold were associated with surgical outcomes; cigarette smoking was the independent predictive prognostic factor for the surgical outcomes.

Comparing Gelfoam vs fat as a sealing material in stapedotomy: A prospective double-blind randomised clinical trial.

OBJECTIVES: One research aspect of stapes surgery is various materials that are used to seal the oval window. Several materials are used to seal the oval window, for example adipose tissue, perichondrium, vein graft, gelatin sponge (Gelfoam), blood clot and soft connective tissue. Up to now, there has been no randomised clinical trial that has evaluated the effects of different types of sealing material on hearing outcomes after stapedotomy. Hence, the present study aimed to find out which of these materials; fat or Gelfoam was associated with better hearing outcome, when used as a sealing material. DESIGN: This prospective, double-blind, randomised clinical trial was carried out on ears that had undergone stapedotomy. SETTING: Dastgheib Hospital affiliated to Shiraz University of Medical Sciences, a referral otology centre in southern Iran. PARTICIPANTS: A total of 176 primary stapedotomies were analysed. Fat harvested from the ear lobule was used in 86 ears and Gelfoam in 90 ears. MAIN OUTCOME MEASURES: Preoperative and postoperative pure tone audiometric data and incidence of sensorineural hearing loss were evaluated. RESULTS: Total of 90.7% of all ears in the fat group and 87.8% of ears in Gelfoam group achieved postoperative air-bone gap (ABG) within 20 dB, and this difference was not significant. There was no case of sensorineural hearing loss (defined as 10 dB or more reduction in BC threshold) in both groups in mean frequencies of 0.5-3 kHz. There were 9 cases of sensorineural hearing loss at 4 kHz in the fat group vs 4 in the Gelfoam group. The occurrence of sensorineural hearing loss in different frequencies was not significant between the two groups (P > 0.05). In addition, there was no case of dead ear in either group. CONCLUSIONS: We found similarity between hearing outcome in the Gelfoam and fat as sealing materials in stapedotomy. We believe that the first limitation of this study was the short-term follow-up in stapedotomy. The other issue is that one has to be cautious when using our result, which might not be applicable in larger fenestra stapedectomy.

Iatrogenic obstructive hydrocephalus resulting from Gelfoam accumulation within the cerebral aqueduct: a case report.

The authors present the case of a previously healthy 12-year-old male with intractable seizures localized to a right frontal area of encephalomalacia and porencephalic cyst who underwent resection of the seizure focus. The surgical resection cavity extended into the right lateral ventricle, and due to encountered hemorrhage, Gelfoam was used for optimal hemostasis. The patient did well following the procedure, but presented 5 months later with headaches and emesis and was discovered to have obstructive hydrocephalus on imaging studies. Endoscopic third ventriculostomy (ETV) was performed, where Gelfoam was encountered in the third ventricle, obstructing the cerebral aqueduct. After the completion of the ETV, the patient did well and continues to be asymptomatic 1 year following the procedure.

Pregnancy after uterine artery embolization using Gelfoam™.

We present a case study of a patient who underwent uterine artery embolization (UAE) using Gelfoam™ (Pfizer, New York, NY, USA) and had a subsequent pregnancy. Our patient, a 38-year-old female (4 Gravida/2 Para), underwent UAE for treatment of symptomatic myoma in September 2005. At the patient's seven-month post procedure visit, she experienced a 43.9% volume reduction in uterine size and 74.5% reduction in volume of the largest fibroid and relief of bulk symptoms and menorrhagia. The patient had a term delivery of healthy twin infants 15 months post embolization.

The Effect of PRP-enriched Gelfoam on Chronic Tympanic Membrane Perforation: A Double-blind Randomized Clinical Trial.

OBJECTIVE: To evaluate the effect of PRP-enriched gelfoam on the healing of chronic TM perforation in comparison with gelfoam alone. METHODS: In this double-blind randomized clinical trial Patients with chronic tympanic membrane were randomly allocated to two groups; intervention group underwent tympanoplasty with platelet rich plasma (PRP)- enriched gel foams and control group underwent operation with conventional gel foams alone. Patients information was recorded 4 and 12 months after surgery. RESULTS: Eventually 24 patients (12 males and 12 females) with a mean age of 43.33 ± 12.34 years in intervention and 41.33 ± 10.02 years in control group underwent analysis (p = 0.667). Complete TM healing was seen in 8 (66.67%) patients in intervention group and 3 (25%) patients in control group three months after intervention (p = 0.031, OR = 5.98). CONCLUSION: Addition of PRP to conventional gelfoams used in TM perforation repair increases the complete healing rate of TM perforation with less morbidity and complications.

Improved bleeding scores using Gelfoam(®) Powder with incremental concentrations of bovine thrombin in a swine liver lesion model.

Topical hemostatic agents are used intra-operatively to prevent uncontrolled bleeding. Gelfoam(®) Powder contains a hemostatic agent prepared from purified pork skin gelatin, the efficacy of which is increased when combined with thrombin. However, the effect of increasing concentrations of thrombin on resultant hemostasis is not known. This study sought to evaluate the ability of various concentrations of thrombin in combination with Gelfoam Powder to control bleeding using a swine liver lesion model. Ten pigs underwent a midline laparotomy. Circular lesions were created in the left medial, right medial, and left lateral lobes; six lesions per lobe. Gelfoam Powder was hydrated with Thrombin-JMI(®) diluted to 250, 375, and 770 IU/mL. Each concentration was applied to two lesion sites per lobe. Bleeding scores were measured at 3, 6, 9, and 12 min using a 6-point system; comparison of bleeding scores was performed using ANOVA with the post hoc Tukey test. The bleeding scores with thrombin concentrations at 770 IU/mL were significantly lower than at 250 and 375 IU/mL at all four time points. The percentage of biopsies with a clinically acceptable bleeding score rose from 37.9, 46.6, and 71.2 % at 3 min to 55.2, 69.0, and 88.1 % at 12 min in the 250, 375, and 770 IU/mL thrombin groups, respectively. The study showed that the hemostatic response to thrombin was dose-related: using higher concentrations of thrombin with Gelfoam Powder yielded improved hemostasis, as determined by lower bleeding scores.

Suspected intraoperative anaphylaxis to gelatin absorbable hemostatic sponge.

Anaphylaxis under anesthesia is a life-threatening medical emergency that requires rapid identification and treatment. Allergies to agents with which the general population are likely to come into contact are usually identified, but patients are exposed to uncommon agents during anesthesia and surgery. Here, we describe a case of anaphylaxis under anesthesia implicating Gelfoam sponges.

Osteosarcoma cells enhance angiogenesis visualized by color-coded imaging in the in vivo Gelfoam® assay.

We previously described a color-coded imaging model that can quantify the length of nascent blood vessels using Gelfoam® implanted in nestin-driven green fluorescent protein (ND-GFP) nude mice. In ND-GFP mice, nascent blood vessels are labeled with GFP. We report here that osteosarcoma cells promote angiogenesis in the Gelfoam® angiogenesis assay in ND-GFP mice. Gelfoam® was initially transplanted subcutaneously in the flank of transgenic ND-GFP nude mice. Seven days after transplantation of Gelfoam®, skin flaps were made and human 143B osteosarcoma cells expressing green fluorescent protein (GFP) in the nucleus and red fluorescent protein (RFP) in cytoplasm were injected into the transplanted Gelfoam®. The control-group mice had only implanted Gelfoam®. Skin flaps were made at days 14, 21, and 28 after transplantation of the Gelfoam® to allow imaging of vascularization in the Gelfoam® using a variable-magnification small animal imaging system and confocal fluorescence microscopy. ND-GFP expressing nascent blood vessels penetrated and spread into the Gelfoam® in a time-dependent manner in both control and osteosarcoma-implanted mice. ND-GFP expressing blood vessels in the Gelfoam® of the osteosarcoma-implanted mice were associated with the cancer cells and larger and longer than in the Gelfoam®-only implanted mice (P < 0.01). The results presented in this report demonstrate strong angiogenesis induction by osteosarcoma cells and suggest this process is a potential therapeutic target for this disease.

Comparison of UVB and UVC effects on the DNA damage-response protein 53BP1 in human pancreatic cancer.

We have previously demonstrated that ultraviolet (UV) light is effective against a variety of cancer cells expressing fluorescent proteins in vivo as well as in vitro. In the present report, we compared the DNA damage repair (DDR) response of pancreatic cancer cells after UVB or UVC irradiation. The UV-induced DNA damage repair was imaged with green fluorescent protein (GFP) fused to the DDR-related chromatin-binding protein 53BP1 in MiaPaCa-2 human pancreatic cancer cells growing in 3D Gelfoam® histoculture and in superficial tumors grown in nude mice. 53BP1-GFP forms foci during DNA damage repair. A clonogenic assay in 2D monolayer culture initially showed that UVC and UVB inhibited MiaPaCa-2 cell proliferation in a dose-dependent manner, with UVC having more efficacy. Three-dimensional Gelfoam® histocultures and confocal imaging enabled 53BP1-GFP foci to be observed within 1 h after UV irradiation, indicating the onset of DDR response. UVB-induced 53BP1-GFP focus formation was observed up to a depth of 120 µm in MiaPaCa-2 cells on Gelfoam® compared to 80 µm for UVC. UVB-induced 53BP1-GFP focus formation was observed up to a depth of 80 µm in MiaPaCa-2 cells, implanted within skin flaps in mice, at a significantly greater extent than UVC. MiaPaCa-2 cells irradiated by UVB or UVC in the skin-flap mouse model had a significant decrease in tumor growth compared to untreated controls with UVB having more efficacy than UVC. Our results demonstrate that UVB has greater tissue penetration than UVC because of its longer wavelength and has clinical potential for eradicating superficial cancer.

3-dimensional tissue is formed from cancer cells in vitro on Gelfoam®, but not on Matrigel™.

Cell and tissue culture can be performed on different substrates such as on plastic, in Matrigel™, and on Gelfoam(®), a sponge matrix. Each of these substrates consists of a very different surface, ranging from hard and inflexible, a gel, and a sponge-matrix, respectively. Folkman and Moscona found that cell shape was tightly coupled to DNA synthesis and cell growth. Therefore, the flexibility of a substrate is important for cells to maintain their optimal shape. Human osteosarcoma cells, stably expressing a fusion protein of α(v) integrin and green fluorescent protein (GFP), grew as a simple monolayer without any structure formation on the surface of a plastic dish. When the osteosarcoma cells were cultured within Matrigel™, the cancer cells formed colonies but no other structures. When the cancer cells were seeded on Gelfoam(®), the cells formed three-dimensional tissue-like structures. The behavior of 143B osteosarcoma cells on Gelfoam(®) in culture is remarkably different from those of these cells in monolayer culture or in Matrigel™. Tissue-like structures were observed only in Gelfoam(®) culture. The data in this report suggest a flexible structural substrate such as Gelfoam(®) provides a more in vivo-like culture condition than monolayer culture or Matrigel(TM) and that Matrigel(TM) does not result in actual three-dimensional culture.