Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06513182
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
Do Wound Protectors Reduce Contamination in Total Shoulder Arthroplasty
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Do Wound Protectors Reduce Contamination in Total Shoulder Arthroplasty A Randomized Controlled Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Prosthetic joint infection is a devastating complication of shoulder arthroplasty A relatively novel method of preventing PJI has been with the use of a wound protection device There is minimal investigative research on the use of a wound protector in shoulder arthroplasty specifically with an ability to decrease wound contamination The investigators primary purpose of the proposed study is to determine if the use of a wound protector deceases the deep wound colonization of bacteria in primary shoulder arthroplasty A secondary purpose is to evaluate if the wound protector decreases soft tissue trauma during total shoulder arthroplasty
Detailed Description:
Prosthetic joint infection PJI is a relatively uncommon but devastating complication of shoulder arthroplasty Published rates of PJI after shoulder arthroplasty range one to ten percent Since the advent of surgery infection has been a constant battle As a profession we have made strides in preventing infection Infection prevention started with the popularization of hand washing and preparation and draping of the sterile field in the nineteenth and twentieth centuries with more recent advancements including pre-operative and intra-operative antimicrobial washes antibiotic powders and ultraviolent light exposure Despite these advancement PJI continues to be a problem in orthopaedic arthroplasty surgery and we need to continue to improve our infection prevention techniques
Risk factors for PJI in shoulder arthroplasty include revision surgery obesity male gender younger age and non-osteoarthritis indication for surgery Unfortunately the majority of these risk factors are non-modifiable and are difficult to mitigate short of avoiding surgery on these patients Due to this surgeons need to continue to find ways of preventing PJI both pre-operatively and intra-operatively The most frequent bacteria responsible for shoulder PJI are cutibacterium acnes and s epidermidis causing an estimated 67 and 27 percent of shoulder PJIs respectively C acnes is difficult to prevent due to its prevalence in the sebaceous glands in the shoulder neck and upper back area Published methods of preventing c acnes infection include pre-operative antibiotics skin preparation with hydrogen peroxide wash betadine wash after skin incision and many others Most of these methods focus on destroying the bacterium that are present in the wound The inherent problem is that c acnes is symbiotic and lives in human skin therefore attempting to destroy it is an uphill battle as it will continue to recolonize the wound through the operation
A relatively novel method of preventing PJI has been with the use of a wound protection device While there is some outcome data with the use of this device in hip arthroplasty there is minimal data in regards to shoulder arthroplasty The only peer-reviewed study of use of a flexible wound protector in shoulder arthroplasty demonstrated a decrease in c acnes colonization in shoulder wounds after placement of a wound protector The purpose of the proposed study is to determine if the use of a wound protector deceases the deep wound colonization of c acnes in primary shoulder arthroplasty
PRELIMINARY STUDIES
A study at the investigators institution looked at the use of a hydrogen peroxide skin preparation prior to shoulder arthroplasty surgery and found that the standardized peroxide preparation decreased surgical wound colonization with c acnes to 10 percent versus 35 percent in the control group While the proposed study is different the investigators intend to use a similar study protocol as this is a proven protocol that worked effectively within this institution
Risk factors for PJI in shoulder arthroplasty include revision surgery obesity male gender younger age and non-osteoarthritis indication for surgery Unfortunately the majority of these risk factors are non-modifiable and are difficult to mitigate short of avoiding surgery on these patients Due to this surgeons need to continue to find ways of preventing PJI both pre-operatively and intra-operatively The most frequent bacteria responsible for shoulder PJI are cutibacterium acnes and s epidermidis causing an estimated 67 and 27 percent of shoulder PJIs respectively C acnes is difficult to prevent due to its prevalence in the sebaceous glands in the shoulder neck and upper back area Published methods of preventing c acnes infection include pre-operative antibiotics skin preparation with hydrogen peroxide wash betadine wash after skin incision and many others Most of these methods focus on destroying the bacterium that are present in the wound The inherent problem is that c acnes is symbiotic and lives in human skin therefore attempting to destroy it is an uphill battle as it will continue to recolonize the wound through the operation
A relatively novel method of preventing PJI has been with the use of a wound protection device While there is some outcome data with the use of this device in hip arthroplasty there is minimal data in regards to shoulder arthroplasty The only peer-reviewed study of use of a flexible wound protector in shoulder arthroplasty demonstrated a decrease in c acnes colonization in shoulder wounds after placement of a wound protector The purpose of the proposed study is to determine if the use of a wound protector deceases the deep wound colonization of c acnes in primary shoulder arthroplasty
PRELIMINARY STUDIES
A study at the investigators institution looked at the use of a hydrogen peroxide skin preparation prior to shoulder arthroplasty surgery and found that the standardized peroxide preparation decreased surgical wound colonization with c acnes to 10 percent versus 35 percent in the control group While the proposed study is different the investigators intend to use a similar study protocol as this is a proven protocol that worked effectively within this institution
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None