Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06338163
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-03-23
Brief Title:
Polihexanide SSIs Measures Bundle PSMB During Enhanced Recovery After Major Digestive Surgery
Sponsor:
Marco Catarci
Organization:
Ospedale Sandro Pertini Roma
Study Overview
Official Title:
Polihexanide SSIs Measures Bundle PSMB During Enhanced Recovery After Major Digestive Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POSSIBLE
Brief Summary:
This is a randomized controlled prospective multicenter superiority trial with two parallel treatment groups and single blinding local investigators performing postoperative follow up will be blinded for group allocation with prospective enrollment planned from July 2024 to June 2025 in 20 Italian surgical centers All patients undergoing elective major gastro-intestinal GI tract surgery upper GI HPB lower GI will be included in a prospective database after written informed consent A total of 2000 patients is expected based on a mean of 100 cases per center
Detailed Description:
Just after signing a written informed consent to participate patients will randomly be assigned either to the experimental group Polihexanide bundle or to the control group Block randomization blocks of 10 patients per single participating center will be performed using an unstratified computer generated randomization list All operations will be performed according to local criteria of the participating center Hair removal will be accomplished on the day of surgery with electronic clippers Alcohol-based solutions of chlorhexidine for surgical site skin preparation will be used A first dose of perioperative iv antibiotics will be administered 30 minutes before skin incision choice of the antibiotic according to local criteria in all patients Additional intraoperative doses will be administered for procedures exceeding two half-lives of the antibiotic At the end of the operation the peritoneal cavity will be rinsed routinely with 09 sodium chloride solution normal saline NS at body temperature Before closure of fascia instruments and gloves will be changed The eventual placement of drains in the peritoneal cavity andor creation of an intestinal stoma will be recorded No subcutaneous suture or drainage will be done Skin will be closed with either staples intracutaneous running suture or interrupted sutures
Potential patient-specific and intraoperative risk factors will be recorded sex age body mass index nutritional status frailty indication to surgery benign vs malignant disease perioperative administration of steroids renal failure and dialysis cardiovascular or respiratory disease American Society of Anesthesiologist class bowel preparation type of approach operative time presence of peritoneal cavity drainage During the postoperative period patients will be examined by the attending surgeon daily Fever central temperature 38 C pulse abdominal signs bowel movements volume and aspect of drainage if present will be recorded daily The local attending surgeon will make any decision for complementary exams and imaging according to his own criteria The rate of any adverse event will be calculated and graded according to the Clavien-Dindo criteria 19 and to Japan Clinical Oncology Group Postoperative Complications JCOG-PC extended criteria 20 including all anastomotic leaks wound infection according to the definitions of the Centers for Disease Control and Prevention and wound culture pneumonia clinical symptoms and physical and radiological examinations central venous line infection positive blood culture urinary tract infection positive urine culture with bacterial count ERAS pathway items will be defined according to national 27 guidelines measuring adherence upon explicit criteria All data will be recorded for a minimum of 8 weeks 60 days after surgery PROM questionnaires will be administered to all enrolled patients four to one week before the planned operation at discharge and 6 to 8 weeks after the operation
After anonymization all data of each single case will be prospectively uploaded by local investigators on a web-based database protected by individual access credentials and incorporated into a spreadsheet for data analysis Any eventual discrepancy andor mismatch will be checked addressed and solved through strict cooperation between coordinating and local investigators
Potential patient-specific and intraoperative risk factors will be recorded sex age body mass index nutritional status frailty indication to surgery benign vs malignant disease perioperative administration of steroids renal failure and dialysis cardiovascular or respiratory disease American Society of Anesthesiologist class bowel preparation type of approach operative time presence of peritoneal cavity drainage During the postoperative period patients will be examined by the attending surgeon daily Fever central temperature 38 C pulse abdominal signs bowel movements volume and aspect of drainage if present will be recorded daily The local attending surgeon will make any decision for complementary exams and imaging according to his own criteria The rate of any adverse event will be calculated and graded according to the Clavien-Dindo criteria 19 and to Japan Clinical Oncology Group Postoperative Complications JCOG-PC extended criteria 20 including all anastomotic leaks wound infection according to the definitions of the Centers for Disease Control and Prevention and wound culture pneumonia clinical symptoms and physical and radiological examinations central venous line infection positive blood culture urinary tract infection positive urine culture with bacterial count ERAS pathway items will be defined according to national 27 guidelines measuring adherence upon explicit criteria All data will be recorded for a minimum of 8 weeks 60 days after surgery PROM questionnaires will be administered to all enrolled patients four to one week before the planned operation at discharge and 6 to 8 weeks after the operation
After anonymization all data of each single case will be prospectively uploaded by local investigators on a web-based database protected by individual access credentials and incorporated into a spreadsheet for data analysis Any eventual discrepancy andor mismatch will be checked addressed and solved through strict cooperation between coordinating and local investigators
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None