The US Food and Drug Administration (FDA) has green-lighted Cohera Medical’s TissuGlu, the first tissue adhesive for internal use.
TissuGlu is a urethane-based adhesive that a surgeon can use to connect tissue flaps made during abdominoplasty surgery. Connecting the tissue flaps with an internal adhesive may reduce or eliminate the need for postoperative surgical draining of fluid between the abdominoplasty tissue flaps.
Drops of liquid TissuGlu are applied by a surgeon using a handheld applicator. After applying the drops, the surgeon positions the abdominoplasty flap in place. Water in the patient’s tissue starts a chemical reaction that bonds the flaps together. The surgeon then proceeds with standard closure of the skin using sutures.
The FDA’s review of TissuGlu included data from a clinical study of 130 participants undergoing elective abdominoplasty. Half of the participants received surgical drains while the other half received TissuGlu and no drains. The study results showed that 73% of participants who received TissuGlu required no postoperative drains In the 27% of patients who did require invasive treatments, 21% received needle aspirations alone. Six percent of the TissuGlu group received both needle aspirations and drains for persistent seroma formation.
Participants who received TissuGlu without surgical drains were generally able to return to most daily activities sooner than those who had surgical drains. There was no difference between the two groups in reported levels of pain or discomfort due to the surgery.
TissuGlu is manufactured by Cohera Medical Inc, located in Pittsburgh.