Evaluation of a Novel Technique for Wound Closure Using a Barbed Suture

Abstract

Sir: In the early 1990s, I conceived of a new device to approximate soft tissues that did not invoke the ischemia inherent to a knotted loop. Inspired by the porcupine, I envisioned two quills pointed in opposite directions. I recognized that it could be inserted with a cannula or with needles on each end. I notified my employer, Duke University, of these ideas. With their permission, I sought patents in the United States, Japan, and Europe. In 1993 and 1994, I submitted patents for the “quill” in a cannula and for the needled variant, respectively. While Dr. Sulamanidze may have independently derived a technique to close wounds in 1999, I noted in my U.S. patent no. 6,241,747, filed 5 years earlier, that the bidirectionally barbed suture can “be sewn into tissue as by a conventional technique.” I founded Quill Medical in 1999 to pursue this technology, and the U.S. Food and Drug Administration requested a human study for approval. Polydioxanone had been selected for the first product because it can be used in many tissues. However, it is not my preference for a subcuticular closure; this layer was mandated by the Food and Drug Administration, presumably to monitor the device for visible signs of inflammation and because it is a relatively low-risk application. Likewise, the length of follow-up and other study parameters were chosen to seek Food and Drug Administration approval and to show equivalence of barbed to conventionally knotted polydioxanone. Further effort and longer follow-up did not seem warranted, given that very few surgeons will use polydioxanone in the dermis. However, many American surgeons use a rapidly absorbable subcuticular suture for breast and body lifts. The risk of infection is much lower than that manifested in the cesarean section wound and is offset by improved cosmesis and less discomfort for the patient. Should the surgeon choose to remove the suture, a permanent polymer such as polypropylene would be preferred. The technique would require that the first bite, with each needle, enter with wound from the skin’s surface. This exposed portion would be cut and the trailing ends pulled out. These sutures can be used in virtually any area where conventional sutures are now used. I anticipate that they will eventually be available in a wide range of sizes and polymers. Their morphology may vary depending on the targeted tissues. I look forward to their widespread adoption for the benefit of surgeons and our patients. Gregory L. Ruff, M.D. 55 Vilcom Circle, Suite 310 Chapel Hill, N.C. 27514 [email protected] DISCLOSURE The author is a paid consultant to Angiotech, which manufactures the barbed sutures used in the study.