Clinical trial

SURGX Antimicrobial Gel Versus Povidone-iodine Skin Incision Prep for the Prevention of Bacterial Seeding in Total Shoulder Arthroplasty

NCT05919888

Name

32325

Description

Comparing the growth of intra-operative tissue cultures of Cutibacterium Acnes after primary shoulder replacement when using a no-prep control group versus antimicrobial wound gel versus betadine applied to the skin layer after the skin incision has been made. Reducing the bacteria present in the deep tissues at the end of the surgery may prevent infections from developing in the future.

Trial arms

Trial start

2023-06-26

Estimated PCD

2023-11-14

Trial end

2023-11-14

Status

Completed

Phase

Early phase I

Treatment

Povidone-Iodine

Applied to skin incision.

Arms:

Povidone-iodine

Other names:

Betadine

SURGX Wound Gel

Applied to skin incision.

Arms:

SURGX Wound Gel

Size

Primary endpoint

Positive culture as determined by the presence of Cutibacterium acnes (C. acnes) - Superficial

2 weeks following surgery

Positive culture as determined by the presence of Cutibacterium acnes (C. acnes) - Deep

2 weeks following surgery

Positive culture as determined by the presence of Cutibacterium acnes (C. acnes) - Implant

2 weeks following surgery

Eligibility criteria

Inclusion Criteria: * Patient is planned to undergo elective primary anatomic or reverse shoulder arthroplasty. Exclusion Criteria: * Patient is undergoing revision shoulder replacement surgery. * Patient has a known allergy to iodine, benzalkonium chloride, or polythylene glycol.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a prospective clinical trial in which patients will be assigned a study arm in sequential fashion.', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 60, 'type': 'ACTUAL'}}

Updated at

2023-11-18

1 organization

1 product

4 indications

Organization

Product

Indication

Indication

Indication

Indication

Prosthetic joint infection