Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04609306
Status:
COMPLETED
Last Update Posted:
2022-11-03
First Post:
2020-10-22
Brief Title:
Hydrogen Peroxide to the Wound Following Surgical Incision Affecting Cultures in Primary Shoulder Arthroplast
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
Official Title:
How Does Hydrogen Peroxide Application to the Wound Following Surgical Incision Affect C Acnes Cultures in Primary Shoulder Arthroplasty
Status:
COMPLETED
Status Verified Date:
2024-06
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:
None
Brief Summary:
Cutibacterium acnes has been the focus of much recent shoulder literature as it has been found to be both a common cause of periprosthetic joint infection as well as a common contaminant in shoulder surgery Standard skin preparations have been found to be ineffective at eradicating C acnes colonization on the skin and deep dermis of patients undergoing surgery Recent literature has shown that skin preparation with 3 hydrogen peroxide solution is effective for decreasing the rate of cultures positive for C acnes in both dermal and deep cultures however a positive rate of 10-17 has still been reported despite this skin preparations The current theory is that standard skin preparation does not remove C acnes from the deep dermis which subsequently contaminates the deep tissue We hypothesize that application of 3 hydrogen peroxide to the deep dermal layer immediately following the skin incision will even further decrease the rate of C acnes contamination during surgery
Detailed Description:
Over 50000 people in the United States have shoulder replacement surgery each year Of these it is reported that 04-29 of anatomic total shoulder arthroplasties aTSA and 1-10 of reverse shoulder arthroplasties rTSA are complicated by periprosthetic joint infection PJI
Cutibacterium Acnes C acnes an indolent organism found on the skin and in the sebaceous glands around the shoulder and back makes the diagnosis of shoulder PJI particularly challenging Multiple studies have shown that C acnes can be isolated from deep cultures in up to 40 of patients without prior surgery undergoing primary total shoulder arthroplasty although whether this indicates actual colonization of the joint or contamination is an area of debate
A recent development in shoulder surgery is the use of hydrogen peroxide to decrease the C acnes load in the deep dermis sebaceous glands with the hope that this will prevent contamination of the joint during shoulder joint replacement surgery Application of a widely commercially-available 3 topical Hydrogen peroxide in water solution in vitro has been found to completely eradicate C acnes growth within 5 minutes and has been shown in clinical trials when used as part of the skin preparation to decrease the rate of positive cultures for C acnes from 35 to 10 for deep cultures and from 34 to 17 for superficial dermal cultures While these results show marked improvement compared to standard skin preparations the 17 with positive dermal cultures is still concerning given the significant morbidity associated with a PJI
Our hypothesis is that an additional application of hydrogen peroxide to the dermis itself immediately following the skin incision will be even more effective at eradicating this potential source of contamination deep in the joint
Cutibacterium Acnes C acnes an indolent organism found on the skin and in the sebaceous glands around the shoulder and back makes the diagnosis of shoulder PJI particularly challenging Multiple studies have shown that C acnes can be isolated from deep cultures in up to 40 of patients without prior surgery undergoing primary total shoulder arthroplasty although whether this indicates actual colonization of the joint or contamination is an area of debate
A recent development in shoulder surgery is the use of hydrogen peroxide to decrease the C acnes load in the deep dermis sebaceous glands with the hope that this will prevent contamination of the joint during shoulder joint replacement surgery Application of a widely commercially-available 3 topical Hydrogen peroxide in water solution in vitro has been found to completely eradicate C acnes growth within 5 minutes and has been shown in clinical trials when used as part of the skin preparation to decrease the rate of positive cultures for C acnes from 35 to 10 for deep cultures and from 34 to 17 for superficial dermal cultures While these results show marked improvement compared to standard skin preparations the 17 with positive dermal cultures is still concerning given the significant morbidity associated with a PJI
Our hypothesis is that an additional application of hydrogen peroxide to the dermis itself immediately following the skin incision will be even more effective at eradicating this potential source of contamination deep in the joint
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OCR39759 | OTHER | UF OnCore | None |