Trends in Interventional Clinical Trials Within Plastic Surgery.

[BACKGROUND] A small proportion of prospective clinical trials in plastic surgery are related to craniofacial surgery. Understanding the current use of clinical trials research within plastic surgery is essential to further development of level I studies, particularly within underrepresented subspecialties like craniofacial surgery.

[METHODS] The ClinicalTrials.gov database was used to collect data regarding registered clinical trials within plastic surgery and relevant subspecialties. Different search terms that represented plastic surgery and its subspecialties were used to identify specific clinical trials. Variables collected included the host country, sponsor type, collaborator type, intervention type, study phase, and primary purpose.

[RESULTS] There were 257 clinical trials found using the "plastic surgery" search term. For the subspecialty analysis, there were 44 craniofacial trials identified. Craniofacial trials were primarily funded by academic institutions/hospitals and foundations, with minimal industry funding. Among other subspecialties, "hand surgery" (n=352) had the most trials followed by "breast reconstruction" (n=136). "Plastic surgery," "hand surgery," "craniofacial," "aesthetic breast surgery," and "breast reconstruction" trials were mostly funded by academic institutions and hospitals. "Microsurgery" and "aesthetic plastic surgery" trials were mostly funded by industry. Significant variations existed for country of origin, sponsor source, study type, and study phase for the subspecialties.

[CONCLUSIONS] Clinical trials in craniofacial surgery make up a small percentage of prospective clinical trials within plastic surgery. Craniofacial trials tended to be funded by academic institutions with lower industry sponsorship. Increased focus on prospective craniofacial trials is vital for advancing care for congenital and traumatic craniofacial conditions in the United States and worldwide.