The Food and Drug Administration issued a go signal allowing use of XSTAT 30 wound dressing to common people. The product is utilized by military groups to control excessive or life-threatening bleeding.
XSTAT 30 is an expandable and multi-sponge product that can be effective in hindering blood flow when tourniquet is unavailable or cannot be applied like in the groin or armpit. This is also used in case of emergency especially when hospital personnel are not present at the scene yet.
Between 30 and 40 percent of civilians die as a result of hemorrhage secondary to traumatic injuries as per the report of the United States Army Institute of Surgical Research. Of these numbers, 33 to 56 percent die before reaching a health facility.
"When a product is developed for use in the battlefield, it is generally intended to work in a worst-case scenario where advanced care might not be immediately available," Office of Device Evaluation in the FDA's Center for Devices and Radiological Health William Maisel said.
The package containing the device has one to three applicators with 92 compressed sponges inside. The sponges expand, fill up the wound cavity and make a barrier against blood flow that could last up to 4 hours, enough to buy time and send a patient for surgery. However, the product is not allowed on chest, pelvis, abdomen and tissues found just above the collarbone.
The number of sponges to be used may differ in patients as factors like wound size and depth need to be taken into consideration. The sponges with a size diameter of 9.8 millimeters and height of 4 to 5 millimeters can absorb 3 milliliters of blood or fluid. With 92 sponges in each applicator, it can approximately absorb a pint or 300 milliliters of fluid.
All sponges applied should be removed before closing the wound during operation. With its visible X-ray marker, these can be easily viewed and detected.
"It is exciting to see this technology transition to help civilian first-responders control some severe, life-threatening bleeding while on the trauma scene," Maisel stated.
