Needle-to-suture ratio, as well as suture material, impacts needle-hole bleeding in vascular anastomoses.

OBJECTIVES: The purpose of this study was to examine the influence of material variables on needle-hole bleeding in vascular anastomoses. Material variables include suture size, needle-tip geometry and diameter, needle coating, suture material and coating and swage area. We attempted to determine whether particular suture material and a reduced needle-to-suture ratio (N:S ratio) could reduce the vessel wall defect and reduce needle-hole bleeding, without changing the suture diameter used for the anastomosis. METHODS: A comparative analysis was made of the needle-hole leak rate in end-to-end anastomoses of an ePTFE®-ePTFE® vascular graft with a PROLENE® polypropylene suture with HEMO-SEAL™ technology (HS, 1.84:1 N:S ratio), standard PROLENE® polypropylene suture (polypropylene 1, 2.41:1 N:S ratio), an alternate standard PROLENE® polypropylene suture (polypropylene 2, 2.06:1 N:S ratio) and a GORE-TEX™ ePTFE® suture (ePTFE® suture, 1.4:1 N:S ratio) in an ex vivo cardiopulmonary bypass pulsatile flow loop model using heparinized porcine blood. Testing was completed within the model with an activated clotting time between 250 and 500 s, at near normothermia (33-35°C) and at normotensive pressure levels (120/80 mmHg). A sample size of n = 20 was completed for each group. RESULTS: The average total sample leak rate was 19.8 ± 4.5 ml/min for the HS suture, 57.2 ± 7.2 ml/min for polypropylene 1, 33.8 ± 4.1 ml/min for polypropylene 2 and 46.5 ± 10.3 ml/min for the ePTFE suture. The average needle-hole leak rates were 0.63 ± 0.13 ml/min for the HS suture, 1.94 ± 0.23 ml/min for polypropylene 1, 1.14 ± 0.14 ml/min for polypropylene 2 and 1.56 ± 0.34 ml/min for the ePTFE® suture. A two-sided 95% confidence interval for the difference in leak rates showed that there were significant differences (44-67% reduction) in favour of the HS suture when compared with the alternative needles with the same suture material and different N:S ratios, and also a reduction (59%) compared with the sample with smaller N:S ratios but different suture material. CONCLUSIONS: The N:S ratio as well as the physical characteristics of the suture material are important factors in reducing needle-hole bleeding in vascular anastomoses.

A prospective, randomized, controlled trial of the efficacy and safety of fibrin pad as an adjunct to control soft tissue bleeding during abdominal, retroperitoneal, pelvic, and thoracic surgery.

BACKGROUND: This study evaluated the hemostatic effectiveness and safety of Fibrin Pad (Omrix Biopharmaceuticals Ltd.) vs absorbable hemostat in patients undergoing nonemergent surgery. Fibrin Pad is a topical absorbable hemostat designed to be effective in a variety of soft tissues and across multiple bleeding intensities. STUDY DESIGN: Patients 18 years and older, requiring abdominal, retroperitoneal, pelvic, or thoracic (noncardiac) surgery and with an appropriate soft-tissue target bleeding site (TBS), were randomized to receive Fibrin Pad or absorbable hemostat (NCT00658723). Patients were stratified by bleeding severity at the TBS. Assessments included percentage of patients achieving hemostasis at 4 minutes after randomization with no rebleeding requiring treatment during the subsequent 6 minutes (primary endpoint), proportion of patients achieving hemostasis at 10 minutes, and incidence of treatment failure. RESULTS: On the primary endpoint, 98.3% of patients with Fibrin Pad and 53.3% with absorbable hemostat achieved hemostasis at 4 minutes (p < 0.0001). The treatment differential was magnified (efficacy was maintained with Fibrin Pad but decreased with absorbable hemostat) with increasing bleeding intensity: in patients with mild bleeding, 100.0% vs 80.0% achieved hemostasis with Fibrin Pad and absorbable hemostat (p = 0.03), respectively; rates were 96.6% vs 26.7%, respectively (p < 0.0001) with moderate bleeding. Percentages of patients who achieved hemostasis at 10 minutes were: Fibrin Pad, 98.3% and absorbable hemostat, 73.3% (p < 0.0001). Incidences of adverse events were comparable between groups. CONCLUSIONS: Fibrin Pad is superior to absorbable hemostat (SURGICEL Original Absorbable Hemostat [Ethicon]) in soft-tissue bleeding control and is safe and effective as an adjunct for rapidly and reliably achieving hemostasis for soft-tissue bleeding during surgery.

Safety and hemostatic efficacy of fibrin pad in partial nephrectomy: results of an open-label phase I and a randomized, standard-of-care-controlled phase I/II study.

BACKGROUND: Bleeding severity, anatomic location, tissue characteristics, and visibility are common challenges encountered while managing intraoperative bleeding, and conventional hemostatic measures (suture, ligature, and cautery) may sometimes be ineffective or impractical. While topical absorbable hemostats (TAH) are useful hemostatic adjuvants, each TAH has associated disadvantages. METHODS: We evaluated the safety and hemostatic efficacy of a new advanced biologic combination product-fibrin pad-to potentially address some gaps associated with TAHs. Fibrin pad was assessed as adjunctive hemostat in open partial nephrectomy in single-center, open-label, Phase I study (N = 10), and as primary hemostat in multicenter, single-blind, randomized, standard-of-care (SOC)-controlled Phase I/II study (N = 7) in Israel. It was used to control mild-to-moderate bleeding in Phase I and also spurting arterial bleeding in Phase I/II study. Phase I study assessed safety and Phase I/II study, proportion of successes at 10 min following randomization, analyzed by Fisher exact tests at 5% significance level. RESULTS: Phase I (N = 10): All patients completed the study. Hemostasis was achieved within 3-4 min (average = 3.1 min) of a single application in all patients. Fibrin pad was found to be safe for human use, with no product-related adverse events reported. Phase I/II (N = 7): Hemostatic success at 10 min (primary endpoint) was achieved in 3/4 patients treated with fibrin pad versus 0/3 patients treated with SOC. No clinically significant change in laboratory or coagulation parameters was recorded, except a case of post-procedural hemorrhage with fibrin pad, which was considered serious and related to the fibrin pad treatment, and required re-operation. Although Data Safety Monitoring Board authorized trial continuation, the sponsor decided against proceeding toward an indication for primary treatment of severe arterial hemorrhage as a replacement for sutures. The study was suspended after 7/30 planned subjects were enrolled. CONCLUSIONS: The first-in-man trial of fibrin pad demonstrated its safety and efficacy as an adjunctive hemostatic technique for mild-to-moderate bleeding in partial nephrectomy. The study also suggested that the product should not replace sutures or meticulous surgical techniques for the treatment of severe arterial hemorrhage. TRIAL REGISTRATION: Phase I/II trial, NCT00598130.

Clinical evaluation of long-term safety and effectiveness of a third-generation thermal uterine balloon therapy system for heavy menstrual bleeding.

STUDY OBJECTIVES: To estimate the incidence of amenorrhea at 36 months after treatment using a third-generation thermal uterine balloon therapy (UBT) system and to compare it with the first-generation UBT system. The secondary objective was to estimate the effect of post-procedure curettage on patient outcomes at 36 months after endometrial ablation. DESIGN: Multicenter controlled study (Canadian Task Force classification I). SETTING: Thirteen hospitals: 12 in the United States and 1 in Mexico. PATIENTS: Two-hundred fifty premenopausal women aged at least 30 years with heavy menstrual bleeding not responsive to previous medical therapy for at least 3 months. INTERVENTION: After treatment with a third-generation thermal UBT system, patients were randomly assigned to receive post-procedure curettage (PPC) or no PPC. MEASUREMENTS AND MAIN RESULTS: Amenorrhea was estimated at 12 months using individual success defined by a pictorial blood loss assessment chart score of 0, and at 24- and 36-month follow-up by patient response of amenorrhea on a 5-point scale (amenorrhea, spotting, and light, normal, or excessive bleeding). In the intention-to-treat population, at 36 months after ablation, the amenorrhea rate was 26.8% with the third-generation UBT system, and 13.0% with the first-generation UBT system. Results by assigned intervention were 29.8% in the no PPC group vs 23.8% in the PPC group. CONCLUSION: At extended 36-month follow-up, results were similar to the previously reported results at 1 year using prospectively defined matched-pair analysis, and demonstrated superiority in treating amenorrhea using the third-generation UBT system vs the first-generation UBT system.

A randomized trial of aprotinin-free fibrin sealant versus absorbable hemostat.

BACKGROUND: This study evaluated the safety and hemostatic effectiveness of a tranexamic acid- and aprotinin-free fibrin sealant versus an absorbable hemostat in soft tissue during elective retroperitoneal or intra-abdominal surgery. MATERIALS AND METHODS: This randomized, active-controlled, multicenter study enrolled patients who were undergoing elective retroperitoneal or intra-abdominal surgery and required adjunctive hemostatic measures at the target bleeding site (TBS). Patients were randomized (time = 0 minutes) to receive fibrin sealant or absorbable hemostat. The primary endpoint was the absence of bleeding at the TBS at 10 minutes. Secondary endpoints included the absence of bleeding at 4 and 7 minutes and the incidence of treatment failure (bleeding at 10 minutes or brisk bleeding requiring additional hemostatic measures), and the incidence of complications potentially related to bleeding. Adverse events were assessed. RESULTS: Patients (N = 124) were randomized to receive fibrin sealant (n = 62) or absorbable hemostat (n = 62). A higher percentage of patients who received fibrin sealant versus absorbable hemostat achieved hemostasis within 10 minutes (95.2% vs 82.3%; 95% CI, 1.02-1.35) and also at 4 (74.2% vs 54.8%; 95% CI, 1.04-1.80) and 7 (90.3% vs 77.4%; 95% CI, 1.00-1.39) minutes. A lower incidence of treatment failure was observed for patients receiving fibrin sealant. Similar incidences of adverse events and complications potentially related to bleeding were observed. CONCLUSIONS: This tranexamic acid- and aprotinin-free fibrin sealant is safe and effective for achieving hemostasis in soft tissue during elective retroperitoneal or intra-abdominal surgery.

Comparison of Recurrence Rates in Obese and Non-Obese Patients Undergoing Ventral Hernia Repair with Lighter-Weight, Partially Absorbable Mesh.

Lighter-weight, large pore meshes with absorbable layers are designed for intra-abdominal placement in laparoscopic ventral hernia repair. This retrospective review of 86 patients who underwent ventral hernia repair with PROCEED™ Surgical Mesh (Ethicon, Inc., Somerville, NJ) represents an evaluation of a cohort of patients implanted with this mesh. All patients implanted with PROCEED Mesh for ventral hernia repair between October 2006 and December 2007 were contacted and asked to participate in an evaluation of their hernia repair. Patients were evaluated for pain, recurrence of their hernia and other potential complications. Eight patients underwent open repair; all others were performed laparoscopically. One patient continued to have pain at 1 year. Twelve developed seromas early on and 5 required drainage by a single puncture each. None persisted. There were 4 recurrences with none in patients with a Body Mass Index 3 32. One case of abdominal wall cellulitis responded to antibiotics. There were no wound infections, mesh infections, bowel obstructions or enteric fistulas. This study demonstrates the utility of a lighter-weight, large pore, partially absorbable mesh for intraperitoneal use in laparoscopic ventral hernia repair and indicates this mesh is strong enough for use in obese patients.