Improvements to Randomized Controlled Trials Are Needed in Trauma Surgery
Berg A, Lyons NB, Badami A, et al. Statistical Power of Randomized Trials in Trauma Surgery. J Am Coll Surg. 2023, in press.
Randomized trials are viewed as the most dependable sources of evidence to guide clinical practice decisions. Important features of a high-quality clinical trial include adequate sample size, a statement of primary and secondary outcomes of interest, a clear calculation of statistical power to achieve validity and detect significant differences, documentation of criteria for inclusion and exclusion of subjects, and other items included in the 2022 revision of the CONSORT checklist.*
Arthur Berg, DO, and coauthors performed a study that evaluated 187 randomized trials conducted between 2000 and 2021 that focused on patients with traumatic injuries. The analysis found that sample size calculations were not included in more than half of the studies, and failure to reach adequate enrollment occurred in 27% of trials. Adequate power to detect large differences in outcomes was present in 65% of studies, and less than half of studies were powered to detect a small difference in outcomes. Only 11% of published randomized trials complied with the CONSORT reporting guidelines.
The authors concluded that there is a need for improvement in study design, conduct, and reporting. Achieving this goal would be facilitated by increasing compliance with the CONSORT checklist.
*The CONSORT checklist is described in detail in two Journal of the American Medical Association articles: “Guidelines for Reporting Outcomes in Trial Reports: The CONSORT-Outcomes 2022 Extension” and “Guidelines for Reporting Outcomes in Trial Protocols” The SPIRIT-Outcomes 2022 Extension.”)
Editorial
Ferrada, P. The Power of Science: Randomized Trials in Trauma Surgery and The Need for Quality Data. J Am Coll Surg. 2023, in press.
In the editorial that accompanied the article, Paula Ferrada, MD, FACS, noted that there are significant challenges to conducting high-quality randomized trials involving trauma patients, some of which include the need to change treatment approaches on short notice, difficulty obtaining informed consent, and inability to perform placebo-controlled trials. Despite these obstacles, improved study design is clearly needed so that dependable evidence to guide clinical decisions can be produced.
Microdosing Incisional Antibiotics Lowers Rate of SSI in Skin Cancer Surgery
Goh M, Hollewand C, McBride S, et al. Effect of Microdoses of Incisional Antibiotics on the Rate of Surgical Site Infections in Skin Cancer Surgery: A Randomized Clinical Trial. JAMA Surg 2023;158(7):718-26. doi: 10.1001/jamasurg.2023.1201
Prevention of surgical site infections (SSI) is an important goal of surgical practice, and a major obstacle to achieving adequate prevention of SSI is increasing resistance to antimicrobial agents in microorganisms that cause SSI. This randomized trial evaluated delivery of antimicrobial agents directly into the surgical incision tissue in patients undergoing excision of skin cancers by injection of microdoses of antimicrobial agents combined with local anesthetic. This method could potentially reduce the risk of increasing bacterial resistance to antimicrobials by avoiding systemic dosing for SSI prophylaxis.
The main outcome of interest was SSI defined as a standardized postoperative wound infection score of 5. Randomized patients (n = 681, 1133 lesions) received local anesthetic only or local anesthetic combined with flucloxacillin or clindamycin. The rates of SSI were 5.7% in the local anesthetic only arm, 5.3% in the flucloxacillin + local anesthetic arm and 2.1% in the clindamycin + local anesthetic arm. The authors concluded that injection of clindamycin as a microdose combined with local anesthetic was effective and safe for reducing SSI. They recommended that this technique be included in clinical practice guidelines for care of patients with skin cancer.
Editorial
Sergesketter AR, Hollenbeck ST. Local Delivery of Antibiotics-Applications in Cutaneous Surgery and Beyond. JAMA Surg 2023;158(7):727. doi: 10.1001/jamasurg.2023.1215
In the editorial that accompanied the article, Amanda R. Sergesketter, MD, and Scott T. Hollenbeck, MD, FACS, noted that microdosing of antimicrobials into the surgical incision site has potential value not only for skin cancer treatment but for breast procedures, skin flap procedures, and for management of complex wounds.
