Ignite Creation Date:
2024-05-06 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03523962
Status:
COMPLETED
Last Update Posted:
2023-05-09
First Post:
2018-04-30
Brief Title:
Pre-operative Alcohol Skin Solutions in Fractured Extremities
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
PREPARE A Pragmatic Randomized Trial Evaluating Pre-operative Alcohol Skin Solutions in FRactured Extremites
Status:
COMPLETED
Status Verified Date:
2024-09
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:
PREPARE
Brief Summary:
The prevention of infection is an important goal influencing peri-operative care of extremity fracture patients Standard practice in the operative management of extremity fractures includes sterile technique and pre-operative skin preparation with an antiseptic solution The available solutions kill bacteria and decrease the quantity of native skin flora thereby decreasing surgical site infection SSI While there is extensive guidance on specific procedures for prophylactic antibiotic use and standards for sterile technique the evidence regarding the choice of antiseptic skin preparation solution is very limited for extremity fracture surgery
Detailed Description:
More than one million Americans suffer an extremity fracture broken bone in the arm leg or pelvis that requires surgery each year Approximately 5 or 50000 of surgical fracture patients develop a surgical site infection SSI which is twice the rate among most surgical patients and nearly five times the rate among patients undergoing elective orthopaedic surgeries eg joint replacement Patients who develop a SSI after their fracture fixation surgery experience a long and difficult treatment pathway Researchers have identified that when a fracture patient experiences a SSI they typically undergo at least two additional surgeries to control the infection spend a median of 14 additional days in the hospital and have significantly lower health related quality of life HRQL Similarly results from the recently completed Fluid Lavage of Open Wounds FLOW trial confirmed that patients who had a SSI or another complication that required an additional surgery reported significantly lower physical and mental HRQL in the 12 months following their fracture compared to patients who did not experience a SSI In the most severe cases when a SSI cannot be controlled a limb amputation becomes necessary
Open fractures closed lower extremity fractures and pelvic fractures represent some of the most severe musculoskeletal injuries Due to their high-energy mechanisms these fractures are often accompanied by soft-tissue injuries that contribute to unacceptably poor outcomes The FLOW trial of 2447 open fracture patients reported a 132 incidence of open fracture-related reoperations Closed fractures of the lower extremity are also at high risk of complications particularly when compared to closed upper extremity fractures For example the rate of SSI in closed tibial plateau and plafond fractures range from 56 - 119 although some cohort studies have reported infection rates as high as 250 This is contrast with SSI rates of 5 for common upper extremity fractures like humeral shaft forearm or distal radius fractures This is further illustrated in a series of 214 deep orthopaedic fracture infections in which 58 occurred in the tibia and ankle and only 10 occurred anywhere in the upper extremity Finally pelvic fractures are associated with some of the most challenging SSIs to treat among closed fractures because of their propensity to gram negative organisms and limitations in reconstruction options post-infection Ultimately infectious complications in these fracture populations lead to prolonged morbidity loss of function and potential limb loss
Open fractures closed lower extremity fractures and pelvic fractures represent some of the most severe musculoskeletal injuries Due to their high-energy mechanisms these fractures are often accompanied by soft-tissue injuries that contribute to unacceptably poor outcomes The FLOW trial of 2447 open fracture patients reported a 132 incidence of open fracture-related reoperations Closed fractures of the lower extremity are also at high risk of complications particularly when compared to closed upper extremity fractures For example the rate of SSI in closed tibial plateau and plafond fractures range from 56 - 119 although some cohort studies have reported infection rates as high as 250 This is contrast with SSI rates of 5 for common upper extremity fractures like humeral shaft forearm or distal radius fractures This is further illustrated in a series of 214 deep orthopaedic fracture infections in which 58 occurred in the tibia and ankle and only 10 occurred anywhere in the upper extremity Finally pelvic fractures are associated with some of the most challenging SSIs to treat among closed fractures because of their propensity to gram negative organisms and limitations in reconstruction options post-infection Ultimately infectious complications in these fracture populations lead to prolonged morbidity loss of function and potential limb loss
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None