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Results from a First-in-Human Trial of a Novel Vascular Sealant.

ABSTRACT: BACKGROUND:Suture hole bleeding from synthetic grafts presents a hemostatic challenge. The designs of many vascular sealants are not optimal (non-adherence to wet surfaces, excessive swelling, inflexible). PreveLeak™ (formerly ArterX ((®)) ) is a polyaldehyde-bovine serum albumin-based sealant whose efficacy, safety, and performance were evaluated in this first-in-human study. MATERIALS AND METHODS:A prospective, single-arm, multicenter study was performed in patients undergoing open vascular reconstructions with prosthetic grafts. Sealant was applied to the suture line after completion of the anastomosis. The primary endpoint was the incidence of immediate sealing (without clinically significant bleeding) upon clamp release. Secondary endpoints were time to sealing, safety, and assessment of product performance. RESULTS:Fifty-six anastomoses were performed in 32 patients. Grafts were Dacron (66% of sites), polytetrafluoroethylene (PTFE; 32%), or both Dacron and PTFE (2%). The femoral artery was the most common site of anastomosis (41% of sites). Immediate sealing after clamp release was achieved at all anastomoses (100%); 93% had no bleeding and 7% had oozing. No rebleeding occurred during 10?min of observation. The three most common adverse events were graft or bypass occlusion (n?=?5 patients), infection (n?=?4), and seroma (n?=?3); none were device related. The sealant was considered easy to apply, quickly forming a soft gel, and adhering to tissue and grafts. CONCLUSION:PreveLeak effectively sealed anastomotic suture lines during vascular reconstruction procedures and was considered easy to use. Adverse events were consistent with those commonly observed in patients undergoing surgical procedures. These results provided the support for conducting a larger controlled clinical trial.

SUBMITTER: Florek HJ

PROVIDER: S-EPMC4486749 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature

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Results from a First-in-Human Trial of a Novel Vascular Sealant.

Florek Hans-Joachim HJ Brunkwall Jan J Orend Karl-Heinz KH Handley Ian I Pribble John J Dieck Ronald R

Frontiers in surgery 20150701

<h4>Background</h4>Suture hole bleeding from synthetic grafts presents a hemostatic challenge. The designs of many vascular sealants are not optimal (non-adherence to wet surfaces, excessive swelling, inflexible). PreveLeak™ (formerly ArterX ((®)) ) is a polyaldehyde-bovine serum albumin-based sealant whose efficacy, safety, and performance were evaluated in this first-in-human study.<h4>Materials and methods</h4>A prospective, single-arm, multicenter study was performed in patients undergoing o ...[more]

PMID: 26191528

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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.

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:BackgroundThis phase III, controlled, patient-blinded, multicentre study in two parallel, equal-sized treatment groups compared the efficacy and safety of TISSEEL Lyo, fibrin sealant versus Manual Compression (MC) with surgical gauze pads for use as a haemostatic agent in patients who underwent vascular surgery in Russia.MethodsAdult patients, both genders, who received peripheral vascular expanded polytetrafluoroethylene conduits and had suture line bleeding after surgical haemostasis were enrolled. Patients were randomized to be treated with TISSEEL Lyo or MC. The bleeding needed additional treatment and had to be assessed as grade 1 or 2 bleeding according to the Validated Intraoperative Bleeding scale. The primary efficacy endpoint was the proportion of patients achieving haemostasis at 4 min after treatment application (T4) at the study suture line, which was maintained until the closure of the surgical wound. The secondary efficacy endpoints included the proportion of patients achieving haemostasis at 6 min (T6) and 10 min (T10) after treatment application at the study suture line, which was maintained until closure of the surgical wound, as well as the proportion of patients with intraoperative and postoperative rebleeding. Safety outcomes included incidence of adverse events (AEs), surgical site infections and graft occlusions.ResultsA total of 110 patients were screened; 104 patients were randomized: (TISSEEL Lyo: 51 [49%] patients; MC: 53 [51%] patients). T4 haemostasis was achieved in 43 (84.3%) patients in the TISSEEL Lyo group and in 11 (20.8%) patients in the MC group (p < 0.001). Significantly more patients in TISSEEL Lyo group achieved the haemostasis at T6 (relative risk (RR) of achieving haemostasis 1.74 [95% confidence interval (CI) 1.37; 2.35]) and T10 (RR 1.18 [95% CI 1.05; 1.38]) versus MC. No one had intraoperative rebleeding. Postoperative rebleeding was reported only in one patient in the MC group. No treatment-emergent serious AEs (TESAEs) related to TISSEEL Lyo/MC, TESAEs leading to withdrawal and TESAEs leading to death were reported in patients during the study.ConclusionsData demonstrated TISSEEL Lyo had clinically and statistically significant superiority to MC as a haemostatic agent in vascular surgery at all measured time points including 4, 6 and 10 min and had proven to be safe.

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Results from a First-in-Human Trial of a Novel Vascular Sealant.

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Results from a First-in-Human Trial of a Novel Vascular Sealant.

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