Prontosan Wound Gel for Shoulder Joint Replacement Surgery
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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Treatment
Participants undergo shoulder arthroplasty with either Prontosan gel application or no additional dermal preparation
Culture Monitoring
Cultures are monitored in the lab for growth of C. acnes
Follow-up
Participants are monitored for safety and effectiveness after surgery
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
All patients will receive standard pre-operative prophylactic antibiotics and external skin preparation prior to draping. At the time of the surgery, after the skin incision has been made with a skin knife, the dermal layer will be prepped with Prontosan Wound Gel for patients in this arm. Prontosan Wound gel is an antimicrobial gel agent intended to keep wounds free of bacteria.
All patients will receive standard pre-operative prophylactic antibiotics and external skin preparation prior to draping. At the time of the surgery, after the skin incision has been made with a skin knife, the dermal layer will not be prepped with any additional agents for patients in this arm.
Find a Clinic Near You
Who Is Running the Clinical Trial?
St. Louis University
Lead Sponsor
Innovice, LLC
Collaborator
American Shoulder and Elbow Surgeons
Collaborator
Citations
Prontosan Wound Gel for Shoulder Joint Replacement ...
The purpose of this study is to compare the growth of intra-operative tissue cultures of Cutibacterium Acnes after primary shoulder replacement when using a ...
Efficacy of Commercially Available Irrigation Solutions on ...
The effectiveness of each solution in reducing bacterial load was measured by sonication and colony-forming unit counts. Scanning electron ...
Efficacy of the preformulated irrigation solution Bactisure ...
The main objective of this study was to evaluate the effectiveness (infection cure rate) of preformulated Bactisure® irrigation solution in vivo ...
An In Vitro Study to Assess the Best Strategy for ...
Data show the mean percentage reduction in log cfu/mL for each sequential antiseptic combination applied against all microorganisms (A) and for each ...
What Is the Duration of Irrigation? - In Vitro Study
All tested antiseptic solutions demonstrated successful eradication of all bacterial growth in under 2 minutes of treatment time except chlorhexidine.
Reduction of Bacterial Seeding in Total Shoulder Arthroplasty
Prontosan Wound gel is an antimicrobial gel agent intended to keep wounds free of bacteria. Treatment: Device: Prontosan Wound Gel. Trial ...
Safety and Efficacy of Subscapularis-Sparing Shoulder ... - PMC
Baseline demographic data, procedural data including procedure time and blood loss, and treatment characteristics including surgical approach ...
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