Antibiotic-Coated Sutures for Prosthetic Joint Infections
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if antibiotic-coated sutures perform as well as or better than regular sutures for individuals with joint infections following hip or knee replacements. It tests two types of sutures: one with antibiotics and one without. The antibiotic-coated sutures being tested include Polydioxanone (PDS™ II) and VICRYL™ Plus (Coated VICRYL™ Plus Antibacterial). Individuals who have undergone hip or knee replacement and have a joint infection diagnosed within the past four weeks may be suitable candidates. The goal is to ensure that antibiotic-coated sutures can aid in healing these infections without causing additional issues. As an unphased trial, this study allows participants to contribute to significant research that could enhance treatment options for joint infections.
Will I have to stop taking my current medications?
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 antibiotic-coated sutures are safe for prosthetic joint infections?
Research shows that triclosan-coated braided sutures are generally safe for surgeries. Studies have found that these sutures do not increase the risk of infections at the surgery site compared to regular sutures, indicating they are well-tolerated by most patients.
Regarding side effects, no significant difference exists between triclosan-coated sutures and traditional single-strand sutures. Thus, using triclosan-coated sutures does not introduce new safety concerns. These sutures dissolve on their own, eliminating the need for removal and enhancing convenience.
Overall, evidence supports the safety of triclosan-coated braided sutures in surgeries, making them a good option for managing prosthetic joint infections.12345Why are researchers excited about this trial?
Researchers are excited about using antibiotic-coated sutures for prosthetic joint infections because these sutures have a unique ability to actively prevent infections at the surgical site. Unlike traditional sutures that merely close tissues, the triclosan-coated braided sutures release an antibacterial agent directly where it's needed, helping to reduce the risk of infection during healing. This approach could potentially lower infection rates compared to standard sutures, which do not have antibacterial properties. Additionally, both the triclosan-braided and monofilament sutures are absorbable, which means patients won't need a follow-up procedure to remove them, making the recovery process smoother and more convenient.
What evidence suggests that this trial's treatments could be effective for prosthetic joint infections?
Research has shown that triclosan-coated braided sutures, which participants in this trial may receive, perform as well as regular sutures in many surgeries. Studies have found these sutures to be as effective as traditional ones in preventing infections. Although some studies did not find a significant difference in reducing infections specifically in hip and knee surgeries, these sutures have succeeded in other types of surgeries. Triclosan, a substance that inhibits bacterial growth, can help prevent infections. Using these sutures allows surgeons to maintain strong stitches while also preventing infections.12345
Who Is on the Research Team?
Colin McNamara, MD
Principal Investigator
University of Miami
Are You a Good Fit for This Trial?
This trial is for patients with infections in their artificial knee or hip joints who are being treated using the DAIR protocol. Participants should not have any conditions that would exclude them from the study, which aren't specified here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo DAIR procedures with either triclosan-coated braided sutures or monofilament sutures for closure
Follow-up
Participants are monitored for safety and effectiveness, including wound healing and infection rates
What Are the Treatments Tested in This Trial?
Interventions
- Polydioxanone (PDS™ II ) Sterile Synthetic Absorbable Surgical Suture-Monofilament
- VICRYL™ Plus (Coated VICRYL™ Plus Antibacterial)
Trial Overview
The study is testing if antibiotic-coated braided sutures (VICRYL™ Plus) are as good as or better than standard monofilament sutures (PDS™ II) in treating joint infections after surgery.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients randomized to this arm will receive triclosan-coated braided sutures for closure of the fascia. Following incision and full debridement and irrigation, the fascia will be closed with this suture. Suturing of the fascia typically takes \~10 minutes. As this suture is absorbable, it does not have to be removed. The superficial layers of the skin will be closed with nylon suture.
Patients randomized to this arm will receive monofilament sutures for closure of the fascia. Following incision and full debridement and irrigation, the fascia will be closed with this suture. Suturing of the fascia typically takes \~10 minutes. As this suture is absorbable, it does not have to be removed. The superficial layers of the skin will be closed with nylon suture.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Miami
Lead Sponsor
Citations
NCT07322289 | Antibiotic-coated Braided Suture Study
Several studies in various surgical specialties have demonstrated the effectiveness and non-inferiority of triclosan-coated braided sutures in ...
The role of triclosan-coated suture in preventing surgical ...
Conclusion. The application of triclosan antimicrobial sutures did not reduce the incidence of SSI after hip and knee arthroplasty compared to the controls, and ...
Antibiotic-coated Braided Suture Study - ClinicalTrials.Veeva
Several studies in various surgical specialties have demonstrated the effectiveness and non-inferiority of triclosan-coated braided sutures in ...
Antibiotic-Coated Sutures for Prosthetic Joint Infections
Several studies in various surgical specialties have demonstrated the effectiveness and non-inferiority of triclosan-coated braided sutures in ...
The role of triclosan-coated suture in preventing surgical ...
In this study, we found no statistically significant difference in the effectiveness of antimicrobial sutures in reducing overall SSI, superficial SSI, or deep ...
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