Secondary endpoints were also similar between the Botox and control groups including average time until closure (5 days vs. 2 days; P = .15), hospital stay (24 days vs. 19 days; P = .19), median ICU duration (8 days vs. 6 days; P = 32), and wound infection rate (8% vs. 0%; P > .99).
Given the potential pain effects of Botox, the investigators anticipated a difference in pain medication use, but morphine equivalents were actually slightly higher in the Botox group on postoperative day 1 (120 mg vs. 81.8 mg; P = .27) through day 5 (57.3 vs. 49.0 mg; P = .47), he said.
In trying to explain why the injections failed to prove beneficial, Dr. Zielinski said, “The question that crosses my mind is did we exclude the wrong patients?”
A total of 181 trauma or emergency general surgery patients, aged 18 years and older, with a damage-control laparotomy per the surgeon’s discretion were eligible for the double-blind study, but 87 were excluded because they had one or more exclusion criterion: a body mass index ≥ 50, hemodynamic instability, complicated chronic obstructive pulmonary disease, impaired neuromuscular transmission, aminoglycoside use, international normalized ratio < 1.5, trunk necrotizing fasciitis, metastatic malignancy, or were pregnant or a prisoner.
Patrice Wendling/Frontline Medical News
Dr. Michael Rotondo
Discussant Michael Rotondo of the University of Rochester (New York) Medical Center, applauded the authors for presenting a negative study and called it “impeccably designed” and “a great piece of work.”
Dr. Rotondo went on to ask whether there was any relationship between degree of advancement, abdominal breach, or lateral diameter that predicts success with Botox.
Despite the use of surface wave elastography to measure abdominal tension in eight patients and use of a handheld durometer, Dr. Zielinski said they were unable to accurately measure degree of advancement. Future work may look at the relationship between these factors and will include long-term follow-up to evaluate hernia rates and quality of life. In the one patient with full elastography measurements, abdominal tension trended lower for 2 days after the Botox injection before increasing after primary closure, he said.abdominal tension trended lower for 2 days after the Botox injection before increasing after primary closure, he said.
The study was funded by the EAST Scholar program. Dr. Zielinski, his coauthors, and Dr. Rotondo reported having no financial disclosures.