The patients who undergo elective gastroenterological surgery with a class II (clean-contaminated) surgical wound
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1 Scheduled to undergo elective surgery for esophagus, stomach, duodenum, jejunum, ileum, colorectal, pancreas, liver or biliary tract with a class II (clean-contaminated) surgical wound 2 Age >= 18 years old at the time of consent being obtained by non-blinded investigators. 3 Scheduled to undergo computed tomography one year after surgery 4 Written informed consent provided
Exclusion criteria
Exclusion criteria: 1 Emergency surgery 2 Under 18 years old 3 A history of midline abdominal wall incision 4 A history of abdominal incisional hernia or fascial tear 5 Identification of bacterial infection in the surgical field or the use antibiotic therapy prior to the operation. 6 Presence of a contaminated abdominal cavity due to stoma, intestinal fistula or drainage tube. 7 Open wound management for prior operation. 8 Synchronous operation for more than two targeted organs. 9 Current immunotherapy (>= 40 mg of a corticosteroid per day or azathioprine) 10 Chemotherapy within 14 days prior to surgery 11 A history of radiotherapy of the abdomen 12 Pregnancy 13 Registered for another clinical trial 14 Conditions that make the patient unsuitable for inclusion according to the judgement of non-blinded investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of postoperative wound complications, including wound bleeding, hematoma, surgical site infection, seroma and wound dehiscence within 30 days after surgery, and incisional hernia within 1 year after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of abdominal wall closure and wound pain seven days after surgery | — |
Countries
Japan
Contacts
Saitama Medical Center, Jichi Medical University Department of Surgery