Clinical Data – US

Multi-Center, Comparative Clinical Assessment of Products for Hemostasis and Wound Healing in Endoscope Sinus Surgery

A comparative clinical assessment was conducted to evaluate the efficacy in tissue healing and symptom improvements of three products of hemostasis and wound healing.

Utilizing a consistent protocol, data were collected from multiple medical center from 2000-2003. A total of 218 patients(318 sides) with chronic sinusitis, type II nastal polyps (II term) and recurrent nasal polyps were treated. Cases were assigned randomly to receive one of the three products of hemostasis. Post-surgical follow ups were carried out over a three to six month period. The primary assessment were tissue healing and symptom improvements.

For full report, click here.

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Healing Evaluations Result:

GroupCavitiesGrade I (%)Grade II (%)Grade III (%)Post-op total washings
A

(BloodSTOP® iX)
11899 (84.0)17 (14.4)2 (1.47)0-2
B

(Surgical® Hemostat)
12078 (65.0)33 (27.5)9 (7.5)50
C

(Vaseline® Gauze)
8052 (65.0)21 (26.3)7 (8.75)50

 

Symptom Improvement Evaluations Result:

GroupCavitiesGrade I (%)Grade II (%)Grade III (%)Post-op total washings
A

(BloodSTOP® iX)
118108 (91.5)10 (8.5)0 (0)0 (0)
B

(Surgical® Hemostat)
12088 (73.3)28 (23.3)4 (3.5)0 (0)
C

(Vaseline® Gauze)
8062 (85.0)8 (10.0)4 (5)6 (7.5)

Clinical Experience

BloodSTOP® iX Hemostatic Matrix for Bleeding Control in An Epidermolysis Bullosa (EB) Patient.

A 6 week old, premature female baby with Epidermolysis bullosa (EB) presented at the clinic having developed multiple wounds of the left lower leg…the baby was prone to develop recurrent wounds…The patient had been previously treated for several weeks with ointments and topic dressings with little improvement…We learned about BloodSTOP® iX and felt that its ability to gel and maintain moisture would allow the dressing to control the bleeding and promote healing at the same time…The patient returned to the office in one week and at that visit there was no further bleeding and the wound size was reduced by 80%.

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Dr. Paul M. Glat, MD, FACS

Chief of Plastic Surgery, St. Christopher's Hospital for Children, Philadelphia, PA

Clinical Video

IVC Filter Jugular Placement.

Preclinical Data – US

Efficacy of BloodSTOP® iX, Surgicel, and Gelform in Rat Models of Active Bleeding From Partial Nephrectomy and Aortic Needle Injury

Key Conslusion

BloodSTOP® iX is safe and efficient in achieveling renal parenchymal hemostasis without hilar or parenchymal clamping in partial nephrectomy rat model. The mean bleeding time was dramatically decreased compared with the use of Surgicel. Similarly, in an aortic injury model, BloodSTOP® iX achieved hemostasis faster than either Gelfoam or Surgicel. Improvement in the handling of the product to prevent adherence to any moist surface could place this oxidized material as the top choice of topical hemostatic matrix for nephron-sparing surgery.

For full PDF report, click here.

BloodSTOP® iX Hemostatic Battle Matrix Video

Severe Femoral Artery Hemorrhage 6mm Diameter Arteriotomy Punch
Pre-Clinical Study in Porcine Model
Utilized Validated Military Protocol