New Staples Add to Options for Cesarean Section

SAN DIEGO – Of 500 consecutive cesarean deliveries closed with subcuticular absorbable staples, only one hematoma occurred, and the overall surgical site infection rate was 1.2%, according to study findings.

"This study was surprising," lead investigator Dr. Kirk A. Shibley said in an interview before a poster session at the annual meeting of the American College of Obstetricians and Gynecologists. "I anticipated a low infection rate due to the interrupted and subcuticular nature of the technology, but I did not anticipate that the number of other wound complications would be so low. That is to say that the number of wound hematomas and seromas and separations is almost nonexistent."

Dr. Shibley, who practices obstetrics and gynecology in Edina, Minn., and his associates evaluated data from 500 consecutive cesarean procedures closed with Incisive Surgical’s INSORB absorbable staples. All the operations were performed by five clinicians in a single obstetrics practice during a 4-year period that ended in 2008. The investigators obtained the data from clinic medical records and from 30-day postdischarge infection surveillance programs at two community hospitals.

Dr. Shibley reported that there were only six surgical site infections, for a rate of 1.2%. There was one hematoma, no seromas, and no wound disruptions. In follow-up visits, he said, patients expressed a high level of satisfaction with the results. "The take-home message is that this skin closure technology is fast, and provides low-maintenance, cosmetic wounds with a very low infection and complication rate," he said.

In the poster, Dr. Shibley and his associates postulated that the improved outcomes may be due in part to the fact that the INSORB staples are made of a benign copolymer "of predominately polylactic acid, shown to elicit a very low inflammatory response in animal and human clinical studies, and may account for decreased pain, serous exudate, and other associated complications."

Also, they continued, "absorbable staples are placed entirely within the dermis without the percutaneous insult of metal staples. Absorbable staples avoid the associated patient discomfort and anxiety associated with metal staple removal. The absorbable staples precisely and effectively secure the dermis without tissue strangulation or compression that can occur with ... metal staples."

Dr. Shibley acknowledged that the study is limited as patients were not prospectively randomized to different closure types.

Dr. Shibley disclosed that he is a paid consultant to Incisive Surgical.

SAN DIEGO – Of 500 consecutive cesarean deliveries closed with subcuticular absorbable staples, only one hematoma occurred, and the overall surgical site infection rate was 1.2%, according to study findings.

"This study was surprising," lead investigator Dr. Kirk A. Shibley said in an interview before a poster session at the annual meeting of the American College of Obstetricians and Gynecologists. "I anticipated a low infection rate due to the interrupted and subcuticular nature of the technology, but I did not anticipate that the number of other wound complications would be so low. That is to say that the number of wound hematomas and seromas and separations is almost nonexistent."

Dr. Shibley, who practices obstetrics and gynecology in Edina, Minn., and his associates evaluated data from 500 consecutive cesarean procedures closed with Incisive Surgical’s INSORB absorbable staples. All the operations were performed by five clinicians in a single obstetrics practice during a 4-year period that ended in 2008. The investigators obtained the data from clinic medical records and from 30-day postdischarge infection surveillance programs at two community hospitals.

Dr. Shibley reported that there were only six surgical site infections, for a rate of 1.2%. There was one hematoma, no seromas, and no wound disruptions. In follow-up visits, he said, patients expressed a high level of satisfaction with the results. "The take-home message is that this skin closure technology is fast, and provides low-maintenance, cosmetic wounds with a very low infection and complication rate," he said.

In the poster, Dr. Shibley and his associates postulated that the improved outcomes may be due in part to the fact that the INSORB staples are made of a benign copolymer "of predominately polylactic acid, shown to elicit a very low inflammatory response in animal and human clinical studies, and may account for decreased pain, serous exudate, and other associated complications."

Also, they continued, "absorbable staples are placed entirely within the dermis without the percutaneous insult of metal staples. Absorbable staples avoid the associated patient discomfort and anxiety associated with metal staple removal. The absorbable staples precisely and effectively secure the dermis without tissue strangulation or compression that can occur with ... metal staples."

Dr. Shibley acknowledged that the study is limited as patients were not prospectively randomized to different closure types.

Dr. Shibley disclosed that he is a paid consultant to Incisive Surgical.

SAN DIEGO – Of 500 consecutive cesarean deliveries closed with subcuticular absorbable staples, only one hematoma occurred, and the overall surgical site infection rate was 1.2%, according to study findings.

"This study was surprising," lead investigator Dr. Kirk A. Shibley said in an interview before a poster session at the annual meeting of the American College of Obstetricians and Gynecologists. "I anticipated a low infection rate due to the interrupted and subcuticular nature of the technology, but I did not anticipate that the number of other wound complications would be so low. That is to say that the number of wound hematomas and seromas and separations is almost nonexistent."

Dr. Shibley, who practices obstetrics and gynecology in Edina, Minn., and his associates evaluated data from 500 consecutive cesarean procedures closed with Incisive Surgical’s INSORB absorbable staples. All the operations were performed by five clinicians in a single obstetrics practice during a 4-year period that ended in 2008. The investigators obtained the data from clinic medical records and from 30-day postdischarge infection surveillance programs at two community hospitals.

Dr. Shibley reported that there were only six surgical site infections, for a rate of 1.2%. There was one hematoma, no seromas, and no wound disruptions. In follow-up visits, he said, patients expressed a high level of satisfaction with the results. "The take-home message is that this skin closure technology is fast, and provides low-maintenance, cosmetic wounds with a very low infection and complication rate," he said.

In the poster, Dr. Shibley and his associates postulated that the improved outcomes may be due in part to the fact that the INSORB staples are made of a benign copolymer "of predominately polylactic acid, shown to elicit a very low inflammatory response in animal and human clinical studies, and may account for decreased pain, serous exudate, and other associated complications."

Also, they continued, "absorbable staples are placed entirely within the dermis without the percutaneous insult of metal staples. Absorbable staples avoid the associated patient discomfort and anxiety associated with metal staple removal. The absorbable staples precisely and effectively secure the dermis without tissue strangulation or compression that can occur with ... metal staples."

Dr. Shibley acknowledged that the study is limited as patients were not prospectively randomized to different closure types.

Dr. Shibley disclosed that he is a paid consultant to Incisive Surgical.