Effectiveness of bismuth subgallate for preventing bleeding following adenotonsillectomy: A multicentre study.

BACKGROUND: Tonsillectomy and adenotonsillectomy are surgical procedures routinely performed worldwide, with various complications, including postoperative bleeding (PTH). Among haemostatic agents, bismuth subgallate (BS) has been employed in the past decades, but its use is controversial in children. OBJECTIVE: This retrospective, multicentre study aims to evaluate the effectiveness and safety of BS in preventing PTH following tonsillectomy and adenotonsillectomy. MATERIALS AND METHODS: Two cohorts of children between 0 and 18 years of age were compared in two different hospitals. The first (active) group of patients included children who underwent tonsillectomy/adenotonsillectomy performed using BS added to gauze swabs, whereas this agent was not administered to the second (control) group. The following variables were analysed: age, gender, degree of tonsillar hyperplasia, length of hospital stay, acute complications (including bleeding and infection), further admissions to the Paediatric Emergency Department (PED), and further hospital admissions in the 30 days postoperatively. RESULTS: Four-thousand- seven hundred forty-four children were included in the study, 2598 in the active group and 2146 in the control group. The cases included in the active treatment group displayed a significantly reduced PTH prevalence, 1.4 versus 2.6 % (p < 0.05). No cases of neurological complications or aspiration pneumonia were detected. CONCLUSIONS: This study supports BS as a safe and reliable option for preventing severe PTH following tonsillectomy/adenotonsillectomy.

Bleeding Complications in Relation to the International Normalized Ratio for Dental Extractions in Patients under Chronic Anticoagulant Therapy - An Evaluative Study.

Introduction: Recent simple dental extraction protocols suggest that therapeutic levels of the anticoagulant drug should be maintained because bleeding complications could be managed with local haemostasis manoeuvres. The aim of the present study was to evaluate the association between bleeding complications and the international normalized ratio (INR) values in patients after dental extractions completed with a plug of bismuth subgallate, without interrupting anticoagulant administration. Materials and Methods: Patients undergoing oral Vitamin K antagonist chronic anticoagulant therapy requiring simple dental extractions were included in the study. INRs were recorded on the day of the surgery, and dental extractions were performed applying bismuth subgallate as a haemostatic agent. Patients took their anticoagulation drug normally. Bleeding complications were recorded. Results: The study included 694 patients, of whom 11 (1.58%) presented mediate post-operative bleeding that was effectively controlled through local manoeuvres. No episode of thromboembolism or infectious endocarditis was observed. The incidence of bleeding complications was not related to the INR values (P > 0.05). Discussion: INR values were not related to bleeding complications when simple dental extractions were performed applying bismuth subgallate as a haemostatic agent.

Randomized Clinical Trial Comparing Three Local Hemostatic Agents for Dental Extractions in Patients under Chronic Anticoagulant Therapy - A Comparative Study.

INTRODUCTION: Oral anticoagulants are widely used worldwide for many systemic diseases. Recent oral surgical protocols suggest that therapeutic levels of the anticoagulant drug should be maintained for simple dental extractions because bleeding complications could be managed with proper local hemostasis. The aim of the present study was to compare bleeding complication of three different local hemostatic agents for dental extractions without interrupting drug administration in patients undergoing oral Vitamin K antagonist chronic anticoagulant therapy. MATERIAL AND METHODS: Randomized control trial of three hemostatic agents for dental extractions, in patients under oral anticoagulant therapy without drug interruption. The present study included 240 patients with international normalized ratio between 1.5 and 3.5. Patients took their anticoagulation drug normally. A single surgeon performed calibrated simple dental extractions and applied a plug of bismuth subgallate (BS), fibrin tissue adhesive (FTA) or microfibrillar collagen (MC), assigned randomly. Statistical analysis of bleeding between the groups was performed using the Chi-square test. RESULTS: There was no hemorrhagic complication in the BS group, and only one in the FTA group. However, in the MC group, 10 patients (12.5%) suffered postoperative bleeding. Data analysis showed statistical differences between the MC group and the other two groups (P < 0.05). DISCUSSION: BS and FTA showed similar clinical effectiveness and were more effective than MC for the control of postoperative bleeding in oral anticoagulated patients.

Does Bismuth Subgallate Affect Smell and Stool Character? A Randomized Double-Blinded Placebo-Controlled Trial of Bismuth Subgallate on Loop Duodenal Switch Patients with Complaints of Smelly Stools and Diarrhea.

BACKGROUND: Loop duodenal switch (LDS) can result in fat and starch malabsorption. In a small percentage of patients, a relevant qualitative and quantitative change in stools happens usually characterized by steatorrhea-like diarrhea. Bismuth subgallate (BS) has been marketed as a way to eliminate the odor associated with flatulence and bowel movements. The objective of this study is to see the efficacy and effect of BS on the quality of life (QOL) in patients undergoing LDS. METHODS: A prospective, randomized, double-blinded, placebo-controlled, crossover study was designed. Thirty-six patients who reported flatus and/or stool odor changes and have completed at least 6 months post-LDS were included. Patients participated in two treatment periods, each lasting for 1 week, separated by 1-week washout. Patients received 200 mg BS, 2 capsules per meal, or placebo for 1 week each. The Gastrointestinal Quality of Life Index (GIQLI) questionnaire was used to compare the QOL before the initiation of the therapy and after each treatment completion. RESULTS: Of 36 patients, 5 patients were lost to follow-up and 2 were withdrawn from the study. And 29 patients were included for final analysis. GIQLI scores obtained with BS treatment completion were significantly higher both overall (P = 0.007) and in the digestive domain (P < 0.001) than those obtained before the treatment. GIQLI scores obtained from the other domains were also higher compared to the pre-treatment as well as placebo treatment but not statistically significant. CONCLUSION: In our double-blinded trial, treatment with BS after LDS statistically improves GIQLI score and steatorrhea-like symptoms.

Evaluation of the Effects of Bismuth Subgallate on Wound Healing in Rats. Histological Findings

Abstract Introduction Bismuth subgallate (BS) is a yellow and odorless powder that has hemostatic astringent properties. Some otorhinolaryngologists and dentists currently use this substance to enhance wound healing. Objective The objective of this study is to evaluate the effects of bismuth subgallate on wound healing, through the analysis of inflammatory process, collagen production, and angiogenesis. Method A standard wound was made on the back of 60 male Wistar rats, using a biopsy punch. We created two groups: the experimental group, which underwent daily application of 0.5mg BS over the entire wound, and the control group, which underwent daily application of sodium chloride 0.9%. We performed a qualitative evaluation of the tissue on the third, seventh, and fourteenth day. We assessed inflammatory markers using Hematoxylin and Eosin (HE) stain, used Picrosirius stain for collagen analysis, and immunohistochemistry was used for angiogenesis analysis through evaluation of smooth muscle proliferation. Results Statistically, we found no significant differences between groups regarding inflammatory response on the third (p= 1), seventh (p= 0.474), and fourteenth day (p= 0.303). Also, collagen type I and III production showed no statistical differences between groups on the third (p= 0.436), seventh (p= 0.853), and fourteenth day (p= 0.436) of analysis. Immunohistochemistry did not present differences on angiogenesis between experimental and control group on the third (p= 0.280), seventh (p= 0.971), and fourteenth day (p= 0.218). Conclusion BS does not promote significant changes in inflammatory response, collagen, and angiogenesis. Thus, it does not influence healing on skin wounds on rats.

Evaluation of the Effects of Bismuth Subgallate on Wound Healing in Rats. Histological Findings.

Introduction Bismuth subgallate (BS) is a yellow and odorless powder that has hemostatic astringent properties. Some otorhinolaryngologists and dentists currently use this substance to enhance wound healing. Objective The objective of this study is to evaluate the effects of bismuth subgallate on wound healing, through the analysis of inflammatory process, collagen production, and angiogenesis. Method A standard wound was made on the back of 60 male Wistar rats, using a biopsy punch. We created two groups: the experimental group, which underwent daily application of 0.5mg BS over the entire wound, and the control group, which underwent daily application of sodium chloride 0.9%. We performed a qualitative evaluation of the tissue on the third, seventh, and fourteenth day. We assessed inflammatory markers using Hematoxylin and Eosin (HE) stain, used Picrosirius stain for collagen analysis, and immunohistochemistry was used for angiogenesis analysis through evaluation of smooth muscle proliferation. Results Statistically, we found no significant differences between groups regarding inflammatory response on the third (p = 1), seventh (p = 0.474), and fourteenth day (p = 0.303). Also, collagen type I and III production showed no statistical differences between groups on the third (p = 0.436), seventh (p = 0.853), and fourteenth day (p = 0.436) of analysis. Immunohistochemistry did not present differences on angiogenesis between experimental and control group on the third (p = 0.280), seventh (p = 0.971), and fourteenth day (p = 0.218). Conclusion BS does not promote significant changes in inflammatory response, collagen, and angiogenesis. Thus, it does not influence healing on skin wounds on rats.

Subgalato de bismuto atuando como agente hemostático pós exérese de hiperplasia papilomatosa / Bismuth subgallate as a topical hemostatic after excision of papillomatous hyperplasia

O objetivo do presente trabalho é revisar a literatura a respeito do subgalato de bismuto na realização da hemostasia e prevenção de hemorragia pós-operatória, bem como relatar um caso clínico de um paciente submetido à exérese de hiperplasia papilomatosa com a utilização do subgalato de bismuto como agente hemostático local. Descrição do caso: Paciente do gênero feminino, 51 anos, procurou atendimento apresentando lesões em palato duro. Relatou utilizar prótese total superior há 20 anos, que apresentava em mal estado de higiene, com áreas de desgastes e estava mal adaptada no rebordo alveolar da paciente. Na avaliação intrabucal foi observado diversas pápulas medindo de 2 a 5mm de diâmetro, de coloração avermelhada, forma arredondadas, superfície lisa e consistência fibrosa. A hipótese diagnóstica foi de hiperplasia papilomatosa e o plano de tratamento incluiu a remoção da prótese do paciente por 14 dias, para regressão do quadro inflamatório local e biópsia excisional. Após o procedimento cirúrgico foi aplicado o subgalato de bismuto a 100%, em pó, diretamente no palato e a prótese total foi utilizada para proteção do sítio cirúrgico. Foi observado um bom estado de cicatrização tecidual no pós-operatório e a paciente relatou ausência de complicações. Na literatura, não foi encontrado relato de casos semelhantes, no entanto, o subgalato tem sido utilizado em cirurgias de tonsilectomias palatinas com o mesmo intuito e também é visto sua utilidade como hemostático local e tem a vantagem de ser um instrumento acessível nos serviços públicos de saúde

The purpose of this paper is to review the literature of bismuth subgalate for hemostasis and prevention of post-operative bleeding and report a case of a patient undergoing papillomatous hyperplasia excision with the use of bismuth subgalate as local hemostatic agent. Case report: female patient, 51, sought treatment with lesions on the hard palate. Reported use denture higher 20 years ago, which showed in bad conditions of hygiene, with areas of wear and was ill-suited in the alveolar ridge of the patient. In intraoral evaluation was observed several papule 2 to 5mm in diameter, red in color, round in shape, smooth surface and fibrous consistency. The diagnosis was papillomatous hyperplasia and the treatment plan included removal of the patient’s prosthesis for 14 days, regression to the local inflammatory process and excisional biopsy. After the surgical procedure has been applied bismuth subgallate 100%, in powder form, directly in the palate and the denture was used to protect the surgical site. A good state of tissue healing after surgery and the patient reported no complications were observed. In the literature, it has not found any report of similar cases, however, the subgalate has been used in palatine tonsillectomy surgery with the same purpose and is also seen its usefulness as a local hemostatic and has the advantage of being a handy tool in public health services

Effect of bismuth subgallate on the quality of life in patients undergoing Scopinaro's biliopancreatic diversion.

BACKGROUND: Malabsorptive techniques, such as biliopancreatic diversion, described by Scopinaro, can cause disabling steatorrhea that affects patients' quality of life. Although it usually improves over time, a reduced group of patients can require treatment. The objective of the present study was to assess the effects of bismuth subgallate on the quality of life (QoL) of patients undergoing Scopinaro's biliopancreatic diversion (SBPD) for morbid obesity. The study was conducted at the Hospital Universitario Insular de Gran Canaria, Spain, a public hospital. METHODS: A prospective, observational study in clinical practice was performed to ascertain the effects of bismuth subgallate on QoL in a group of patients undergoing SBPD who reported disabling diarrhea and related odor. Patients received treatment with 2 courses of oral bismuth subgallate, 200 mg every 8 hours for 12 weeks, with a 4-week rest period. Pretreatment and posttreatment surveys were performed. The Gastrointestinal Quality of Life Index (GIQLI) questionnaire was used, which evaluates symptoms, physical status, emotional status, social performance, and treatment effects. RESULTS: Sixty patients--90% women--with a mean age of 45.6 years were included in the study, 65% of which had superobesity. GIQLI scores obtained at treatment completion were significantly higher--both overall and in the various domains--than those obtained before treatment onset (P<.01). When the morbid obesity and superobesity groups were analyzed separately, a significant increase in the scores for both patient groups was also observed (P< .01). CONCLUSIONS: In clinical practice, treatment with bismuth subgallate resulted in a short-term improvement of QoL for patients undergoing SBPD.

Evaluation of bismuth subgallate and adrenaline paste as haemostat in tonsillectomy bleeding.

Haemorrhage is a frequent and often feared complication of tonsillectomy. This has prompted the use of a variety of topical haemostatics such as bismuth subgallate to achieve haemostasis and reduce the risk of postoperative haemorrhage. In this study effect of bismuth subgallate and adrenaline paste was investigated. A total of twenty five subjects undergoing tonsillectomy were randomly recruited. The distinctive feature of study was that each patient constituted a matched pair, with left tonsillar fossa acting as control and right tonsillar fossa as trial side. Bismuth subgallate adrenaline paste was made by mixing 13 gm of Bismuth subgallate powder with 10 ml of normal saline and 0.35 ml of 1: 1000 adrenaline. The application of twin reagent paste resulted in reduced blood loss in trial fosse (60.8 ± 19.3 ml) as compared to control fossa (91.2 ± 20.27) (p < 0.0001). Similarly the average number of ligatures applied to control bleeding was also less in trial fosse. Only one patient reported reactionary haemorrhage while there was no report of secondary haemorrhage from amongst tonsillar fosse on trial side. However, two patients presented with secondary haemorrhage from control side fosse.

The effect of bismuth subgallate as haemostatic agent in tonsillectomy.

Tonsillectomy is one of the frequent operations performed by Otolaryngologists world over: Otolaryngologists are in search of a technique of tonsillectomy where the operation time and operative blood loss is less. This study was carried out to evaluate the effect of bismuth subgallate (BSG) and adrenaline on tonsillectomy time blood loss during the surgery as well as on the number of ties used. A prospective randomized trial of 60 patients was carried out, in which 30 had a tonsillectomy performed using BSG as haemostatic agent and in the remaining no heamostatic agent was used. Application of BSG in the tonsillar fossae reduces the operation time by 31.49%, the operative blood loss by 33.28% and also reduces the number of ties used by 53.33%. All these results are statistically significant.