WoundStat Superior in Hemostatic Comparison

SAN DIEGO — WoundStat, a hemostatic agent approved in August 2007, is superior to other combat hemostatic agents used for combat and civilian trauma, results from a swine study demonstrated.

The product, marketed by TraumaCure Inc., consists of a pure granular smectite composite. In the study, it produced hemostasis in the face of high-pressure arterial bleeding within 3 minutes. WoundStat is currently used as a life-saving tool by the U.S. military in Afghanistan.

"The study protocol was to hold for 3 minutes, but in subsequent studies and observations, 2 minutes was more than sufficient for WoundStat to stop the hemorrhage," Robert F. Diegelmann, Ph.D., said at the annual meeting of the Wound Healing Society. It also would be simple for the victim or medic to apply.

Dr. Diegelmann, professor of biochemistry and molecular biology, anatomy, and emergency medicine at Virginia Commonwealth University, Richmond, led the research team that developed WoundStat at the university's reanimation engineering shock center.

He and his associates compared the performance of WoundStat with Z-Medica Corp.'s QuikClot zeolite granules and QuikClot zeolite Advance Clotting Sponge, HemCon Medical Technologies Inc.'s chitosan bandage, and the U.S. Army field gauze bandage in a lethal vascular injury model developed by the Army (J. Trauma 2007;63:276–84). The protocol involved creating a 6-mm arteriotomy in a vessel of 25 male swine. After 45 seconds of hemorrhage, five animals each were randomized to be treated with the Army field bandage (control group), QuikClot zeolite granules, the QuikClot zeolite Advance Clotting Sponge, the HemCon chitosan bandage, or WoundStat.

The application of WoundStat, a premixed composite available in 5.5-ounce packages, also involved the application of 200 mm Hg pressure over the product in the wound for 3 minutes.

In all swine, fluid resuscitation began at the time each product was applied, with 500 mL of Hextend, followed by lactated Ringer's solution at 100 mL/min to achieve and maintain a mean arterial blood pressure of 65 mm Hg. The study's primary end points were survival, survival time, posttreatment blood loss, and amount of resuscitation fluid required.

All swine in the WoundStat group survived to 180 minutes and required only a single application, Dr. Diegelmann said at the meeting, held in conjunction with a symposium on advanced wound care. One animal in the HemCon chitosan bandage group survived, but none of the animals in the other groups survived.

He reported that survival and survival times for animals in the WoundStat group were significantly greater, compared with those in all other groups. In addition, posttreatment blood loss and lost-resuscitation fluid volume were significantly less for animals in the WoundStat group, compared with all other groups.

Dr. Diegelmann disclosed that he is a paid consultant for TraumaCure Inc.

The interaction of whole blood and WoundStat resulted in the aggregated red cells and formation of fibrin matrix seen in this scanning electron micrograph (3,300X) of a sample fixed during a span of 1 minute after the addition of the blood. Courtesy Dr. Robert F. Diegelmann

SAN DIEGO — WoundStat, a hemostatic agent approved in August 2007, is superior to other combat hemostatic agents used for combat and civilian trauma, results from a swine study demonstrated.

The product, marketed by TraumaCure Inc., consists of a pure granular smectite composite. In the study, it produced hemostasis in the face of high-pressure arterial bleeding within 3 minutes. WoundStat is currently used as a life-saving tool by the U.S. military in Afghanistan.

"The study protocol was to hold for 3 minutes, but in subsequent studies and observations, 2 minutes was more than sufficient for WoundStat to stop the hemorrhage," Robert F. Diegelmann, Ph.D., said at the annual meeting of the Wound Healing Society. It also would be simple for the victim or medic to apply.

Dr. Diegelmann, professor of biochemistry and molecular biology, anatomy, and emergency medicine at Virginia Commonwealth University, Richmond, led the research team that developed WoundStat at the university's reanimation engineering shock center.

He and his associates compared the performance of WoundStat with Z-Medica Corp.'s QuikClot zeolite granules and QuikClot zeolite Advance Clotting Sponge, HemCon Medical Technologies Inc.'s chitosan bandage, and the U.S. Army field gauze bandage in a lethal vascular injury model developed by the Army (J. Trauma 2007;63:276–84). The protocol involved creating a 6-mm arteriotomy in a vessel of 25 male swine. After 45 seconds of hemorrhage, five animals each were randomized to be treated with the Army field bandage (control group), QuikClot zeolite granules, the QuikClot zeolite Advance Clotting Sponge, the HemCon chitosan bandage, or WoundStat.

The application of WoundStat, a premixed composite available in 5.5-ounce packages, also involved the application of 200 mm Hg pressure over the product in the wound for 3 minutes.

In all swine, fluid resuscitation began at the time each product was applied, with 500 mL of Hextend, followed by lactated Ringer's solution at 100 mL/min to achieve and maintain a mean arterial blood pressure of 65 mm Hg. The study's primary end points were survival, survival time, posttreatment blood loss, and amount of resuscitation fluid required.

All swine in the WoundStat group survived to 180 minutes and required only a single application, Dr. Diegelmann said at the meeting, held in conjunction with a symposium on advanced wound care. One animal in the HemCon chitosan bandage group survived, but none of the animals in the other groups survived.

He reported that survival and survival times for animals in the WoundStat group were significantly greater, compared with those in all other groups. In addition, posttreatment blood loss and lost-resuscitation fluid volume were significantly less for animals in the WoundStat group, compared with all other groups.

Dr. Diegelmann disclosed that he is a paid consultant for TraumaCure Inc.

The interaction of whole blood and WoundStat resulted in the aggregated red cells and formation of fibrin matrix seen in this scanning electron micrograph (3,300X) of a sample fixed during a span of 1 minute after the addition of the blood. Courtesy Dr. Robert F. Diegelmann

SAN DIEGO — WoundStat, a hemostatic agent approved in August 2007, is superior to other combat hemostatic agents used for combat and civilian trauma, results from a swine study demonstrated.

The product, marketed by TraumaCure Inc., consists of a pure granular smectite composite. In the study, it produced hemostasis in the face of high-pressure arterial bleeding within 3 minutes. WoundStat is currently used as a life-saving tool by the U.S. military in Afghanistan.

"The study protocol was to hold for 3 minutes, but in subsequent studies and observations, 2 minutes was more than sufficient for WoundStat to stop the hemorrhage," Robert F. Diegelmann, Ph.D., said at the annual meeting of the Wound Healing Society. It also would be simple for the victim or medic to apply.

Dr. Diegelmann, professor of biochemistry and molecular biology, anatomy, and emergency medicine at Virginia Commonwealth University, Richmond, led the research team that developed WoundStat at the university's reanimation engineering shock center.

He and his associates compared the performance of WoundStat with Z-Medica Corp.'s QuikClot zeolite granules and QuikClot zeolite Advance Clotting Sponge, HemCon Medical Technologies Inc.'s chitosan bandage, and the U.S. Army field gauze bandage in a lethal vascular injury model developed by the Army (J. Trauma 2007;63:276–84). The protocol involved creating a 6-mm arteriotomy in a vessel of 25 male swine. After 45 seconds of hemorrhage, five animals each were randomized to be treated with the Army field bandage (control group), QuikClot zeolite granules, the QuikClot zeolite Advance Clotting Sponge, the HemCon chitosan bandage, or WoundStat.

The application of WoundStat, a premixed composite available in 5.5-ounce packages, also involved the application of 200 mm Hg pressure over the product in the wound for 3 minutes.

In all swine, fluid resuscitation began at the time each product was applied, with 500 mL of Hextend, followed by lactated Ringer's solution at 100 mL/min to achieve and maintain a mean arterial blood pressure of 65 mm Hg. The study's primary end points were survival, survival time, posttreatment blood loss, and amount of resuscitation fluid required.

All swine in the WoundStat group survived to 180 minutes and required only a single application, Dr. Diegelmann said at the meeting, held in conjunction with a symposium on advanced wound care. One animal in the HemCon chitosan bandage group survived, but none of the animals in the other groups survived.

He reported that survival and survival times for animals in the WoundStat group were significantly greater, compared with those in all other groups. In addition, posttreatment blood loss and lost-resuscitation fluid volume were significantly less for animals in the WoundStat group, compared with all other groups.

Dr. Diegelmann disclosed that he is a paid consultant for TraumaCure Inc.

The interaction of whole blood and WoundStat resulted in the aggregated red cells and formation of fibrin matrix seen in this scanning electron micrograph (3,300X) of a sample fixed during a span of 1 minute after the addition of the blood. Courtesy Dr. Robert F. Diegelmann