Cosmetic outcome of nonabsorbable continuous intradermal sutures versus skin staples for skin closure following a parotidectomy for benign parotid tumors in adults: open-label randomized controlled trial

Abstract

BACKGROUND: Scars are an inevitable result of a surgical procedure that have a great physical and psychological repercussion on patients. Although sutures are still considered as the standard of care in closing cutaneous wounds, staples are being commonly used as an alternative in head and neck cancer surgery. However, if a more agreeable aesthetic result is wished to be achieved, an intradermal suture is more suited for skin closure. Unfortunately, despite the increasing emphasis on scar cosmesis, there is very little reliable comparative data on which to base closure method selection. OBJECTIVES: Our main objective is to prove that nonabsorbable continuous intradermal sutures will provide a better cosmetic outcome, that being a less visible scarring tissue, when compared to skin staples used for skin closure following a parotidectomy via modified Blair incision (MBI) for benign parotid tumors in adults. When it comes to secondary objectives, we will assess psychosocial and quality of life impact during the postoperative period, wound closure time, post-surgical complications and satisfaction with the incision closure method, all while comparing both techniques. DESIGN: This research is designed as a single-institution, prospective, open-label, randomized clinical trial carried out, from September 2022 to September 2027, at the Oral and Maxillofacial Surgery Department of Hospital Universitari Josep Trueta (HUJT). PARTICIPANTS: All the patients at HUJT with suspected benign parotid tumors (pleomorphic adenoma and Warthin tumors) on preoperative examination, who are scheduled to undergo a parotidectomy via MBI and are at least 18 years old. METHODS: A total of 220 patients will be recruited. Each participant will be assigned with a numeric code and randomized into two groups according to the skin closure method: (A) nonabsorbable continuous intradermal sutures and (B) skin staples. All the data about study variables and covariables will be collected (14 days, 6 and 12 months after the surgery) and analyzed to determine its statistical significance