Skin closure by subcuticular suture or skin stapling after elective hepatobiliary and pancreatic surgery: a single-center, open-label parallel randomized clinical trial

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2020
INTERVENTION: Fascial closure will be performed according to the most recent evidence in order to minimize the risk of dehiscence and fascial site infection. For fascial closure continuous suture with synthetic absorbable monofilament material (i.e. 0 PDS‐II, Ethicon or 0 Maxon, Medtronic) will be performed. Patients will be assigned randomly and parallelly to one of the two treatment arms in a 1: 1 allocation ratio using a masked computer‐generated sequence: Group A (arm 1): skin closure with conventional surgical staples 1‐1.5 cm interval (Medtronic) Group B (arm 2): skin closure with interrupted subcuticular buried sutures using a synthetic absorbable material (i.e. 4‐0 CAPROSYN, Ethicon or 4‐0 no‐coloured MONOSYN, Medtronic) Both study groups are followed equally for a follow‐up period of 30 days, and assessed for the primary endpoint. CONDITION: Superficial surgical‐site infection (sSSI) in elective oncological and non‐oncological hepatobiliary and pancreatic surgery ; Surgery PRIMARY OUTCOME: sSSI rate measured by review of clinical records (i.e. medical history, daily medical records, complementary tests such as microbiological wound tests) at 30 days of follow‐up SECONDARY OUTCOME: ; 1. Incidence of sSSI measured using clinical records at 30 days of follow‐up; 2. Risk factors associated with sSSI measured using review of medical records, including baseline characteristics, previous medical background and variables related to the surgical procedure, at 30 days of follow‐up; 3. Hospital admission days measured using medical records at 30 days of follow‐up; INCLUSION CRITERIA: Adult patients undergoing elective oncological and non‐oncological hepatobiliary and/or pancreatic surgery that have approved and signed the informed consent document
Epistemonikos ID: 46011620f8e7f74965b75e937dd4c296d0c90afc
First added on: Aug 24, 2024