Comparison between two different local hemostatic methods for dental extractions in patients on dual antiplatelet therapy: a within-person, single-blind, randomized study.

BACKGROUND: Dual antiplatelet therapy (DAPT) provides additional risk reduction of ischemic events compared to aspirin monotherapy, at cost of higher bleeding risk. There are few data comparing new techniques for reducing bleeding after dental extractions in these patients. PURPOSE: This study investigated the effectiveness of the HemCon Dental Dressing (HDD) compared to oxidized cellulose gauze. MATERIALS AND METHODS: This randomized study included 60 patients on DAPT who required at least two dental extractions (120 procedures). Each surgical site was randomized to HDD or oxidized regenerated cellulose gauze as the local hemostatic method. Intra-oral bleeding time was measured immediately after the dental extraction and represents our main endpoint for comparison of both hemostatic agents. Prolonged bleeding, platelet reactivity measured by Multiplate Analyser (ADPtest and ASPItest) and tissue healing comparison after 7 days were also investigated. RESULTS: Intra-oral bleeding time was lower in HDD compared with control (2 [2-5] vs. 5 [2-8] minutes, P=0.001). Prolonged postoperative bleeding was observed in 7 cases (11.6%), all of them successfully managed with local sterile gauze pressure. More HDD treated sites presented better healing when compared with control sites [21 (36.8%) vs. 5 (8.8%), P=0.03]. There was poor correlation between platelet reactivity and intra-oral bleeding time. CONCLUSIONS: In patients on DAPT, HDD resulted in a lower intra-oral bleeding time compared to oxidized cellulose gauze after dental extractions. Moreover, HDD also seems to improve healing conditions.

New use of an absorbable adhesion barrier (INTERCEED) for temporary diverting ileostomy in minimally invasive rectal surgery

Objectives: Sometimes, severe adhesion occurs between the rectus abdominis muscle and the ileal intestinal limbs after temporary diverting ileostomy. This can make ileostomy reversal difficult. The aim of the present study is to assess whether absorbable adhesion barrier made of oxidized regenerated cellulose (INTERCEED) could contribute to improved surgical outcomes in stoma reversal. Methods: This was a single-institutional retrospective study. A total of 36 consecutive patients who underwent ileostomy reversal by a single surgeon were retrospectively reviewed. INTERCEED was inserted between the ileal limbs and the rectus abdominis muscle at the time of ileostomy creation in 12 patients. Surgical outcomes of the ileostomy reversal were compared between patients treated with and without INTERCEED. Results:The degree of adhesion formation between the ileal limbs and the rectus abdominis muscles, operating time, and estimated blood loss were significantly reduced in patients treated with INTERCEED compared with those treated by the conventional approach. None of the patients in the INTERCEED group had postoperative complications after the initial surgery and ileostomy reversal. Conclusions: INTERCEED is suitable for insertion between the ileal limbs and the rectus abdominis muscles because of its softness and flexibility. The use of INTERCEED for diverting ileostomy contributes to reduced adhesion formation, operative time, and blood loss in patients, and further research is needed to confirm our results. (AU)

Biological compatibility of oxidized cellulose vs. porcine gelatin to control bleeding in liver lesions in rats.

PURPOSE: To compare biological compatibility, hemostasis, and adhesion formation between oxidized regenerated cellulose and lyophilized hydrolyzed porcine collagen in liver trauma. METHODS: Forty male Wistar rats constituted two groups: group A (oxidized cellulose) and group B (lyophilized hydrolyzed collagen). Standardized liver trauma was made, and the hemostatic agent was applied. Animals in subgroups A7 and B7 were submitted to euthanasia and relaparotomy after seven days, and in subgroups A14 and B14 after 14 days. Macroscopic and microscopic results were evaluated. RESULTS: There was no fluid in the cavity in any of the animals, and adhesions were present in all of them. In the analysis after seven days, the adhesions were grades 3 or 4 and consisted of omentum, small intestine, and abdominal wall (p<0.05). In both groups, the mesh was surrounded by a capsule, which was not observed after 14 days. In the evaluation after 14 days, adhesions were grades 2 or 3 (p>0.05). The microscopic examination showed subacute and chronic reactions, in both groups and in both timepoints, with similar frequency. The intensity of fibrosis always presented positive scores. Microabscesses and xanthomatous macrophages were observed in both groups. CONCLUSIONS: There was no superiority of one agent over the other.

Biological compatibility of oxidized cellulose vs. porcine gelatin to control bleeding in liver lesions in rats

ABSTRACT Purpose: To compare biological compatibility, hemostasis, and adhesion formation between oxidized regenerated cellulose and lyophilized hydrolyzed porcine collagen in liver trauma. Methods: Forty male Wistar rats constituted two groups: group A (oxidized cellulose) and group B (lyophilized hydrolyzed collagen). Standardized liver trauma was made, and the hemostatic agent was applied. Animals in subgroups A7 and B7 were submitted to euthanasia and relaparotomy after seven days, and in subgroups A14 and B14 after 14 days. Macroscopic and microscopic results were evaluated. Results: There was no fluid in the cavity in any of the animals, and adhesions were present in all of them. In the analysis after seven days, the adhesions were grades 3 or 4 and consisted of omentum, small intestine, and abdominal wall (p<0.05). In both groups, the mesh was surrounded by a capsule, which was not observed after 14 days. In the evaluation after 14 days, adhesions were grades 2 or 3 (p>0.05). The microscopic examination showed subacute and chronic reactions, in both groups and in both timepoints, with similar frequency. The intensity of fibrosis always presented positive scores. Microabscesses and xanthomatous macrophages were observed in both groups. Conclusions: There was no superiority of one agent over the other.

Effect of oxidized cellulose on human respiratory mucosa and submucosa and its implications for endoscopic skull-base approaches.

BACKGROUND: Regenerated oxidized cellulose (ROC) sheets have gained popularity as an adjunct to a vascularized nasoseptal flap for closure of dural defects after endoscopic endonasal skull-base approaches (EESBS). However, evidence supporting its impact on the healing process is uncertain. This study was performed to evaluate the impact of ROC on the nasal mucosa and assess its effects on tissue pH, structure, and cell viability. METHODS: In 5 patients, a 1-cm2 piece of ROC gauze was placed on the surface of the middle turbinate before it was resected as part of a standard EESBS. Mucosa treated with ROC was separated from untreated mucosa and a histologic examination of structural changes in the respiratory epithelium was performed. To assess the effect of ROC on pH, increasing amounts of ROC were added to culture medium. Nasal fibroblasts viability was assessed in the presence of ROC before and after the pH was neutralized. RESULTS: Compared with unexposed controls, treated mucosa exhibited a higher incidence of cell necrosis and epithelial cell detachment. When added to Dulbecco's modified Eagle medium, ROC caused a dose-dependent decrease in pH of the medium. Only 1 ± 0.8% of cultured fibroblasts exposed to the ROC-induced acidic medium were alive, whereas 98.25 ± 0.5% of the cells were viable when the pH was neutralized (p < 0.001). CONCLUSION: ROC applied in vivo to nasal mucosa induced epithelial necrosis likely by diminishing the medium pH, because pH neutralization prevents its effect. The ultimate effect of this material on the healing process is yet to be determined.

Comparative study of four different types of intraperitoneal mesh prostheses in rats

Purpose: To compare four types of mesh regarding visceral adhesions, inflammatory response and incorporation. Methods: Sixty Wistar rats were divided into four groups, with different meshes implanted intraperitoneally: polytetrafluoroethylene (ePTFE group); polypropylene with polydioxanone and oxidized cellulose (PCD); polypropylene (PM) and polypropylene with silicone (PMS). The variables analyzed were: area covered by adhesions, incorporation of the mesh and inflammatory reaction (evaluated histologically and by COX2 immunochemistry). Results: The PMS group had the lowest adhesion area (63.1%) and grade 1 adhesions. The ePTFE and PM groups presented almost the total area of their surface covered by adherences (99.8% and 97.7% respectively).The group ePTFE had the highest percentage of area without incorporation (42%; p <0.001) with no difference between the other meshes. The PMS group had the best incorporation rate. And the histological analysis revealed that the inflammation scores were significantly different. Conclusions: The PM mesh had higher density of adherences, larger area of adherences, adherences to organs and percentage of incorporation. ePTFE had the higher area of adherences and lower incorporation. The PMS mesh performed best in the inflammation score, had a higher incorporation and lower area of adherences, and it was considered the best type of mesh.(AU)

Migration of Oxidized Cellulose to the Ventricle as a Complication of Endoscopic Third Ventriculostomy: A Case Report

Endoscopic third ventriculostomy (ETV) is an increasingly common neurosurgical procedure. Hemostatic agentes (porcine gelatin and oxidized cellulose) are normally placed to plug the cortical hole after ETV to avoid cerebral spinal fluid leakage, subdural hygroma, and hemorrhage. Here we report the case of a 6-year-old boy with hydrocephalus who underwent ETV and which oxidized cellulose was placed to plug the cortical hole.Magnetic resonance imaging of the head performed 3 months after the procedure showed the presence of oxidized cellulose in the ventricle. After an unsuccessful attempt to remove the cellulose, it was decided that the patient should be kept under observation. Twoyears later, the child is in good health and without any complaints. Hemostatic agents (especially oxidized cellulose) used on the cortical hole after ETV can migrate to the ventricle and compromise the procedure. Follow-up should be performedfor such patients, and the main focus should be on not causing further injury.

COMPARATIVE ANALYSIS OF SURGICAL HEMOSTATIC SPONGES IN LIVER INJURY: STUDY IN RATS.

BACKGROUND: Obtaining effective hemostasis either in the traumatic or surgical lesions of parenchymal viscera, especially the liver, has always been a challenge. AIM: Comparative study between the use of different hemostatic sponges in hepatic wound and their capacity of integration to cells in a short period. METHODS: Fifteen Wistar rats were divided into three groups. Through laparotomy a standardized wound in hepatic right lobe was made. The animals were treated with three sponges, being gelatin in group I, equine collagen in group II, and oxidized cellulose in group III. The hemostatic capacity was analysed. On the 7º day after surgery samples for histology analysis (H&E and picrosirius) were collected for inflammatory evaluation and collagen quantification (types I and III) with polarized microscopy. RESULTS: All materials used had similar haemostatic effects, with no significant difference in hemostasis time. In the assessment of tissue repair and adhesions provoked, as well as analysis of the inflammatory process, the gelatin sponge presented greater inflammation and adhesions to the contiguous structures to the procedure in relation to the other groups. CONCLUSION: Animals which had their wounds treated with collagen and regenerated cellulose sponges presented better results in relationship to the ones treated with gelatin sponge.

Comparative analysis of surgical hemostatic sponges in liver injury: study in rats / Análise comparativa de esponjas hemostáticas cirúrgicas em ferimento de fígado: estudo em ratos

ABSTRACT Background Obtaining effective hemostasis either in the traumatic or surgical lesions of parenchymal viscera, especially the liver, has always been a challenge. Aim: Comparative study between the use of different hemostatic sponges in hepatic wound and their capacity of integration to cells in a short period. Methods: Fifteen Wistar rats were divided into three groups. Through laparotomy a standardized wound in hepatic right lobe was made. The animals were treated with three sponges, being gelatin in group I, equine collagen in group II, and oxidized cellulose in group III. The hemostatic capacity was analysed. On the 7º day after surgery samples for histology analysis (H&E and picrosirius) were collected for inflammatory evaluation and collagen quantification (types I and III) with polarized microscopy. Results: All materials used had similar haemostatic effects, with no significant difference in hemostasis time. In the assessment of tissue repair and adhesions provoked, as well as analysis of the inflammatory process, the gelatin sponge presented greater inflammation and adhesions to the contiguous structures to the procedure in relation to the other groups. Conclusion: Animals which had their wounds treated with collagen and regenerated cellulose sponges presented better results in relationship to the ones treated with gelatin sponge.

RESUMO Racional A obtenção de hemostasia eficaz nas lesões traumáticas ou cirúrgicas de vísceras parenquimatosas, em especial do fígado, sempre foi desafiante. Objetivo: Comparar o uso de hemostáticos absorvíveis em ferimento hepático quanto à capacidade hemostática e de integração aos tecidos em curto prazo. Métodos: Foram utilizados 15 ratos Wistar separados em três grupos. Foi realizada laparotomia e ferimento padronizado em lobo hepático direito. Os animais do grupo I foram tratados com esponja de gelatina sobre os ferimentos; os do grupo II com esponja de colágeno equino, e os do grupo III com celulose regenerada oxidada. Na ocasião foi estudada a capacidade hemostática. No 7º dia de pós-operatório nova laparotomia foi realizada e foram coletadas amostras para estudos histológicos (H&E e picrosirius) avaliando os processos por microscopia ótica e de polarização para quantificação de colágeno (tipos I e III). Resultados: Todos os materiais usados apresentaram efeitos hemostáticos semelhantes, não havendo diferença significativa no tempo de hemostasia. Na avaliação da reparação tecidual e aderências provocadas, assim como análise do processo inflamatório, os tratados com esponja de gelatina apresentaram maior inflamação e aderências às estruturas contíguas ao procedimento em relação aos outros grupos. Conclusão: Os animais tratados com a esponja de colágeno e celulose regenerada apresentaram resultados melhores que aqueles com esponja de gelatina.

Oestrogen receptor alpha expression in neovaginal tissue of women following modified Abbé-McIndoe technique and in premenopausal women.

The aim of the study was to compare the expression of oestrogen receptor alpha (ERα) in neovaginal tissue of patients with vaginal agenesis following neovaginoplasty using regenerated, oxidised cellulose in premenopausal women. A prospective, observational case-control study was performed on eight patients with vaginal agenesis following modified Abbé-McIndoe neovaginoplasty and 10 control premenopausal women following benign gynaecologic surgery. 6F11 monoclonal antibody was used to determine ERα expression in the vaginal mucosa. Quantitative and qualitative evaluations were performed, respectively, in vaginal epithelium and stroma. The thickness of the vaginal epithelium was determined as the vertical distance between the basal layer cells and the apical surface of the superficial layer. The percentage of ERα-expressing cells was higher in the control group, except in the superficial zone of the epithelium. In the stromal tissue, ERα was detected in only one patient from the neovagina group compared with nine women in the control group. The neovagina group had a statistically thinner epithelium. Our study suggests that women with vaginal agenesis following modified Abbé-McIndoe neovaginoplasty using regenerated oxidised, cellulose experience relatively local hypo-oestrogenism in the first year after surgery, with repercussion in vaginal trophism.

A local hemostatic agent for the management of postpartum hemorrhage due to placenta previa and placenta accreta: a cross-sectional study.

PURPOSE: To describe the use of a local hemostatic agent (LHA) for the management of postpartum hemorrhage (PPH) due to bleeding of the placental bed in patients taken to caesarean section at Fundación Santa Fe de Bogotá University Hospital. SAMPLE: A total of 41 pregnant women who had a caesarean section and developed PPH. METHODS: A cross-sectional study. Analysis of all cases of PPH during caesarean section presented from 2006 up to and including 2012 at Fundación Santa Fe de Bogotá University Hospital. MAIN OUTCOME MEASURE: Emergency hysterectomy due to PPH. RESULTS: The proportion of hysterectomies was 5 vs. 66 % for the group that received and did not receive management with a LHA respectively (PR 0.07, CI 95 % 0.01-0.51 p < 0.01). For the group managed without a LHA, 80 % of patients needed hemoderivatives transfusion vs. 20 % of patients in the group managed with a LHA (PR 0.24, CI 95 % 0.1-0.6 p < 0.01). A reduction in the mean days of hospitalization in addition to a descent in the proportion of patients admitted to the intensive care unit (ICU) was noticed when comparing the group that received a LHA versus the one that did not. CONCLUSION: An inverse association between the use of a LHA in patients with PPH due to bleeding of the placental bed and the need to perform an emergency obstetric hysterectomy was observed. Additionally there was a significant reduction in the mean duration of hospital stay, use of hemoderivatives and admission to the ICU.

Vaginoplasty with oxidized cellulose: anatomical, functional and histological evaluation.

OBJECTIVE: To present and evaluate the histological, anatomical and functional results of the McIndoe procedure, as modified by the application of oxidized cellulose (Surgicel™) in women with vaginal agenesis. STUDY DESIGN: Eleven patients with vaginal agenesis underwent vaginoplasty using a mould that had been wrapped with oxidized cellulose. The surgeries were performed between January 2009 and January 2010. Eight of the patients had been diagnosed with Mayer-Rokitansky-Kuster-Hauser (MRKH) syndrome, and the remaining three had been diagnosed with cervicovaginal agenesis (CVA). The mean follow-up time was 14 months (range, 6-24 months), and it included clinical examinations and evaluation of the Female Sexual Function Index (FSFI). Neovaginal biopsies were taken at the time of surgery and 1-12 months after surgery. The histology of the samples was evaluated to determine squamous epithelialization of the neovaginal tissue over time, and the total collagen content of the neovaginas were compared with normal control subjects. For statistical analysis we employed the ANOVA test and the t-test. RESULTS: At 6 months, anatomical success was achieved in 100% of the MRKH syndrome patients (neovaginal length ≥ 6 cm), and functional success was achieved in 100% of the patients who started their sexual life (FSFI score ≥ 30). Biopsy results showed complete epithelialization of the neovagina after 5 months in all samples, and the collagen content was comparable to that of a normal vagina. One major postoperative complication occurred in a patient with CVA, which culminated in death. The uterovaginal canalization procedure was unsuccessful at creating an outflow tract for regular menses in all cases. CONCLUSIONS: The procedure described here offers patients a functional vagina by means of a simple and low-cost procedure that elicits squamous epithelialization of the neovaginal vault, with total collagen content similar to that of normal vaginal tissue. It is a potential alternative therapeutic approach for MRKH syndrome but not applicable to cases of CVA.

Molde vaginal flexible recubierto de celulosa oxidada: una opción quirúrgica en neovagina en pacientes con síndrome de Rokitansky-Kuster-Hauser / Flexible vaginal mould covered with oxided cellulose: a surgical option in patients with Rokitansky-Kuster-Hauser syndrome

Las alteraciones en la diferenciación de los derivados mullerianos y el seno urogenital es motivo común de consulta en ginecología. La agenesia e hipoplasia vaginal representan algunas alteraciones patológicas de la diferenciación sexual humana. El manejo de estos trastornos está supeditado a la magnitud del daño anatómico y a las repercusiones biopsicosociales que trae consigo esta patología. Desde la perspectiva histórica, se han descrito diferentes técnicas quirúrgicas de neovagina para corregir este tipo de alteraciones. Nosotros presentamos la experiencia obtenida en los últimos años en el manejo quirúrgico y los resultados estéticofuncionales de pacientes con agenesia vaginal atendidas en un Hospital de alta especialidad del Sector Salud en la Ciudad de México. El motivo de consulta en estas pacientes fue fundamentalmente amenorrea primaria, alteraciones anatómicas y disfunción sexual. El rango de edad fluctuó entre los 19 a 28 años. Se efectuaron estudios básicos de laboratorio y gabinete que incluyeron urografía excretora, cariotipo y laparoscopia. En todos los casos se contó con apoyo del servicio de psicología. El diagnóstico en estas pacientes fue síndrorne de Rokitansky-Kuster-Hauser con agenesia de los dos tercios superiores de vagina. Se efectuó neovagina asistida por laparoscopia con modificaciones de la técnica previamente descrita. Y utilizamos un molde vaginal flexible, así como celulosa oxidada para prevenir la fibrosis y la retracción posquirúrgica. Los resultados cosméticos fueron satisfactorios y la disfunción sexual se corrigió en todas las parejas. La neovagina asistida por laparoscopia con uso de molde vaginal flexible y celulosa oxidada es una opción quirúrgica en pacientes con agenesia e hipoplasia vaginal ya que mejora la estética y esfera sexual, alteradas de manera profunda en estas mujeres.

Reconstrucción vaginal / Vaginal reconstruction

En este artículo se revisa las historia de la agenesia congénita de vagina, así como la evolución de las técnicas para la creación de una neovagina. Se comentan las ventajas y desventajas de la técnicas más utilizadas actualmente

Modificación a la técnica de Abbe-Wharton-McIndoe, utilizando celulosa oxidada regenerada en vez de injerto de piel / Modification Abbe-Eharton-McIndoe's techniques, using regenerated oxidized cellulose instead of skin graft

Diversos padecimientos cursan con un desarrollo anormal de la vagina que impide la práctica de relaciones sexuales satisfactorias. Múltiples procedimientos tanto quirúrgicos como no quirúrgicos han sido diseñados para corregir esta situación, la operación de Abbe. Wharton-McIndoe es una con la que se han obtenido los mejores resultados, pero tiene la desventaja de que queda una cicatriz estéticamente desagradable en el sitio donde se toma el injerto de piel. La celulosa oxidada regenerada (COR) (Interceed, Johnson-Johnson Med Inc), ha sido utilizada ampliamente en cirugía pélvica para evitar o disminuir la formación de adherencias sin que se haya descrito su uso en otras áreas. Se decidió utilizar este material en vez del injerto de piel al realizar la operación de Abbe-Wharton-McIndoe con la finalidad de permitir la rápida epitelización de la cavidad recién formada además de evitar la toma de injerto. Se informa de cuatro casos de síndrome de Rokitansky en los cuales se creó una vagina con la técnica de McIndoe utilizando COR en vez de injerto de piel. A las 12 semanas del procedimiento observamos una epitelización completa de la cavidad creada con presencia de epitelio vaginal maduro. Se concluye que la COR es una alternativa en vez del injerto de piel, con las ventajas de que no es necesario la toma del injero además de que se logra una completa y rápida epitelización del lecho quirúrgico