Trial Shows Sealant Gel Closes Spinal Surgery Wounds

(NIH)

A clinical trial led by researchers at University of California at Davis found a gel that creates a watertight seal to close surgical wounds, sealed spinal wounds 100 percent of the time. The UC Davis team reported their findings in the online issue of the journal Spine (paid subscription required).

The trial, funded by the medical products developer Covidien in Bedford, Massachusetts, tested the company’s DuraSeal Spinal Sealant, a polyethylene glycol (PEG) hydrogel sealant as a supplement to sutures in spinal surgery. The material plugs tiny leaks in the dura, the thin sheath inside the spinal column that encloses the spinal cord.

The spinal cord and nerves float in cerebrospinal fluid inside the dura. After spinal surgery, even pinhole-sized leaks of spinal fluid can expose the surgical wound to bacteria, increasing the risk of serious infection, including meningitis, or require another surgery to repair.

The PEG gel quickly solidifies and forms a tight seal when it comes into contact with the body. Other sealants commonly used to create a watertight seal in spinal wounds include fibrin glue, made from other donor blood or animal matter. Fibrin glue, however, is not optimal because it remains in place for only five to seven days and carries a risk of disease transmission.

The study was conducted with 158 patients treated at 24 centers throughout the United States. Patients were randomized in the operating room if a spinal fluid leak was seen after the dura was closed with the sutures. Some 102 patients received the PEG hydrogel spinal sealant and 56 received the standard care of closing the dura with additional sutures and/or fibrin glue. Participants were excluded from the study if they had prior spine surgery or serious concurrent conditions.

The researchers tested whether the treatment had achieved a water-tight seal by attempting to expel spinal fluid through the closed dura. The study found that all patients (100%) who received the sealant had
a watertight closure, a significantly higher rate than the 64 percent with watertight closure using the standard care.

Read more: Laser Suturing in Development for Minimally Invasive Surgery

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