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The effect of fibrin sealant on the prevention of seroma formation after postbariatric abdominoplasty.

ABSTRACT: Seroma formation is one of the most common complications following abdominoplasty. Fibrin sealant/glue has shown mixed results in seroma prevention when used in a variety of procedures. Limited information is available on its effectiveness during postbariatric abdominoplasty.A retrospective chart analysis of 65 consecutive patients who underwent postbariatric abdominoplasty over a course of 16 months by a single surgeon was performed. Two sequential groups either receiving or not receiving fibrin sealant treatment were defined. Seroma formation and initial 24 h drain output volumes were recorded.Three patients in group 1 (9.1%) receiving fibrin sealant developed seroma. Twelve patients in group 2 (28.1%) not receiving fibrin sealant developed seroma; this was statistically significant (P=0.006). Twenty-four hour drain output was also statistically different, with higher initial output in the fibrin sealant group (222.2 mL versus 140.0 mL; P=0.047).Fibrin sealant was a useful adjunct during surgical wound closure and significantly decreased seroma formation in patients undergoing postbariatric abdominoplasty.

SUBMITTER: Lee JC

PROVIDER: S-EPMC3433815 | biostudies-other | 2012

REPOSITORIES: biostudies-other

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The effect of fibrin sealant on the prevention of seroma formation after postbariatric abdominoplasty.

Lee Johnson C JC Teitelbaum Jason J Shajan Josh K JK Naram Aparajit A Chao Jerome J

The Canadian journal of plastic surgery = Journal canadien de chirurgie plastique 20120101 3

<h4>Background</h4>Seroma formation is one of the most common complications following abdominoplasty. Fibrin sealant/glue has shown mixed results in seroma prevention when used in a variety of procedures. Limited information is available on its effectiveness during postbariatric abdominoplasty.<h4>Methods</h4>A retrospective chart analysis of 65 consecutive patients who underwent postbariatric abdominoplasty over a course of 16 months by a single surgeon was performed. Two sequential groups eith ...[more]

PMID: 23997585

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Project description:BackgroundHeterologous fibrin sealant (HFS) consists of a fibrinogen-rich cryoprecipitate extracted from Bubalus bubalis buffalo blood and a thrombin-like enzyme purified from Crotalus durissus terrificus snake venom. This study evaluated the safety and immunogenicity of HFS, estimated the best dose, and assessed its preliminary efficacy in the treatment of chronic venous ulcers (CVU).MethodsA phase I/II non-randomized, single-arm clinical trial was performed on 31 participants, accounting for a total of 69 active CVUs. All ulcers were treated with HFS, essential fatty acid, and Unna boot for 12 weeks. The outcomes assessed were: (1) primary safety, immunogenicity analyses, and confirmation of the lowest safe dose; (2) secondary promising efficacy by analyzing the healing process. Immunogenicity was evaluated using the serum-neutralizing (IgM and IgG) and non-neutralizing (IgA and IgE) antibody techniques against the product. The immuno-detection of IgE class antibodies was assessed using dot-blot assay before and at the end of treatment. Positive samples on dot-blot assays were subsequently analyzed by western blotting to verify the results.ResultsNo severe systemic adverse events related to the use of HFS were observed. Local adverse events potentially related to treatment include ulcer pain (52%), peri-ulcer maceration (16%), peri-ulcer pruritus (12%), critical colonization (8%), peri-ulcer eczema (4%), the opening of new ulcers (4%), and increased ulcerated area 4%). Neutralizing and non-neutralizing antibodies did not show significant deviations at any of the evaluated time points. Blot assays showed that all patients presented negative immunological reactions, either before or after treatment, with the thrombin-like enzyme component. In addition, two participants showed a positive immunological reaction to the cryoprecipitate component, while another two were positive before and during treatment. Regarding the secondary outcomes of preliminary efficacy, a total healing and significant reduction of the area was observed in 47.5 and 22%, respectively. A qualitative improvement was observed in the wound beds of unhealed ulcers.ConclusionsThe investigational HFS bioproduct proved to be safe and non-immunogenic with a good preliminary efficacy for the treatment of CVU, according to the protocol and doses proposed. A multicentric phase III clinical trial will be necessary to verify these findings.

Project description:BACKGROUND:Total knee replacement (TKR) is increasingly performed in short term hospital stay, making same day mobilization an important issue is after surgery. This implies little joint effusion by reducing intra-articular blood loss, which will enhance knee range of motion. The application of a topical fibrin sealant on the intraoperative bare bone and synovial tissue may contribute to better early full mobilization and thus improved functional outcomes. Since ambulation with a fully extended knee is less strenuous, we hypothesized that patients who received fibrin sealant would demonstrate improved early knee extension after six weeks compared to patients who received standard care. METHODS:A multicenter randomized controlled trial in a consecutive series of osteoarthritis patients scheduled for TKR surgery. Participants were randomized to receive fibrin sealant or not before closing the knee joint capsule. Primary outcome was change in knee extension angle(°) at short term (2 weeks) follow-up (cExt). Secondary outcomes were 6-week extension angle, knee flexion angle, hemoglobin loss, blood transfusion rates, complication rates, the Knee Society Score, and the KOOS and EQ5D questionnaires. RESULTS:When data on primary outcome became available from 250 patients, an interim analysis was performed by an independent Data Safety Monitoring Board for safety and effectivity assessment. This analysis showed that sufficient patients were included to detect a cExt of 10° between both groups. Inclusion was stopped however, all in the meantime included patients were treated according to their randomization. A total of 466 were available for analysis. Both groups were comparable in terms of baseline characteristics. The estimated mean cExt difference was 0.2° (95%CI -0.5 to 0.9). No differences in secondary outcomes were found. CONCLUSIONS:No beneficial effects or side effects were found of a topically applied fibrin sealant during TKR surgery. These results discourage the clinical use of a fibrin sealant in TKR. TRIAL REGISTRATION:Dutch Trial Register, NTR2500.

Project description:BackgroundThe relative performance of ART sealant and fluoride-releasing resin sealant in preventing fissure caries in permanent molars was compared in a randomized clinical trial conducted in southern China (ClinicalTrials.gov NCT01829334).MethodsAfter obtaining ethical approval, healthy schoolchildren who had permanent first molars with occlusal fissures which were sound but deep or presented with only incipient caries were recruited for the study. Included molars were randomly allocated into one of four parallel study groups in units of left/right teeth per mouth. Two of the four groups adopted the methods of ART or fluoride-releasing resin sealant placement while the other two groups adopted the topical fluoride application methods. Fissure status of the molars in each group was evaluated every 6 months. Development of dentine caries and sealant retention over 24 months in the molars in the two sealant-using groups was compared in this report. Outcome on cost-effectiveness of all four groups over 36 months will be reported elsewhere.ResultsAt baseline, a total of 280 children (383 molars) with mean age 7.8 years were involved for the two sealant groups. After 24 months, 261 children (357 molars) were followed. Proportions of molars with dentine caries were 7.3% and 3.9% in the ART sealant and fluoride-releasing resin sealant groups, respectively (chi-square test, p = 0.171). Life-table survival analysis showed that sealant retention (full and partial) rate over 24 months for the resin sealant (73%) was significantly higher than that (50%) for the ART sealant (p < 0.001). Molar survival (no development of dentine caries) rates in the ART sealant (93%) and fluoride-releasing resin sealant (96%) groups were not significantly different (p = 0.169). Multilevel logistic regression (GEE modeling) accounting for the effects of data clustering and confounding factors confirmed this finding.ConclusionsThough the retention of fluoride-releasing resin sealant was better than that of the ART sealant, their effectiveness in preventing fissure caries in permanent molars did not differ significantly over 24 months. ART sealants could be a good alternative when and where resources for resin sealant placement are not readily available.

Dataset Information

The effect of fibrin sealant on the prevention of seroma formation after postbariatric abdominoplasty.

Publications

The effect of fibrin sealant on the prevention of seroma formation after postbariatric abdominoplasty.

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