Prontosan Wound Gel for Shoulder Joint Replacement Surgery

RO
AG
Overseen ByAllison Gruender, RN, MSN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether Prontosan Wound Gel can reduce bacteria growth, specifically Cutibacterium Acnes, during shoulder replacement surgery. Researchers aim to determine if applying this gel after the skin incision results in fewer bacteria compared to not using any additional gel. Suitable candidates for this trial are English-speaking men undergoing their first total shoulder replacement surgery for conditions such as severe rotator cuff issues or shoulder arthritis. As an unphased trial, participants contribute to important research that may enhance surgical outcomes.

Do I need to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Prontosan Wound Gel is safe for use in surgery?

Research has shown that Prontosan Wound Gel, which helps keep wounds free of bacteria, is generally well-tolerated. Although specific research on using Prontosan for shoulder surgery is lacking, its role as a bacteria-fighting gel suggests safety for skin use. The "Not Applicable" trial phase indicates that this treatment is already considered safe for other uses. Participants typically do not report major side effects, making it a promising choice for keeping surgical wounds clean.12345

Why are researchers excited about this trial?

Prontosan Wound Gel is unique because it acts as an antimicrobial agent, specifically targeting and preventing bacteria from infecting surgical wounds. Unlike typical wound care methods that might rely solely on antibiotics or standard skin prep, Prontosan is applied directly to the dermal layer during surgery to provide an extra layer of defense. Researchers are excited about this treatment because it offers a novel approach to infection prevention, potentially reducing post-surgical complications and improving recovery outcomes for shoulder joint replacement patients.

What evidence suggests that Prontosan Wound Gel might be an effective treatment for reducing Cutibacterium Acnes in shoulder joint replacement surgery?

Research has shown that Prontosan Wound Gel effectively reduces bacteria in wounds. Studies have found that it lowers the growth of bacteria like Cutibacterium acnes. Fewer bacteria help prevent infections after surgery. In this trial, participants in one arm will have their dermal layer prepped with Prontosan Wound Gel during surgery. The gel acts as an antimicrobial, killing germs and keeping the wound clean. Early results suggest that using Prontosan during surgeries can help keep the area free from harmful bacteria, making it a promising option for preventing infections.13467

Who Is on the Research Team?

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Randall Otto, MD

Principal Investigator

St. Louis University

Are You a Good Fit for This Trial?

This trial is for individuals undergoing primary shoulder replacement surgery who may be at risk of bacterial infection from Cutibacterium Acnes. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and not have conditions that could interfere with the study.

Inclusion Criteria

I am a man over 18 planning a first-time shoulder replacement for specific shoulder conditions.

Exclusion Criteria

Patients with allergy to active ingredients in Prontosan gel
Patient is non-English speaking
I am female.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Treatment

Participants undergo shoulder arthroplasty with either Prontosan gel application or no additional dermal preparation

1 day
1 visit (in-person)

Culture Monitoring

Cultures are monitored in the lab for growth of C. acnes

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Prontosan Wound Gel

Trial Overview

The study is testing if applying Prontosan wound gel after making a skin incision during shoulder replacement can reduce the growth of bacteria compared to no additional treatment. It's a comparison between treated versus untreated surgical sites.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Prontosan Wound GelExperimental Treatment1 Intervention
Group II: No skin incision preparationActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

St. Louis University

Lead Sponsor

Trials
197
Recruited
41,400+

Innovice, LLC

Collaborator

American Shoulder and Elbow Surgeons

Collaborator

Trials
3
Recruited
220+

Citations

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