Suture Material for Vascular Disease
(CLOSM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two types of stitches for closing groin incisions after certain blood vessel surgeries. The goal is to determine whether Vicryl or PDS stitches are more effective for these procedures. Individuals undergoing planned vascular surgery with groin incisions may be suitable candidates, particularly if surgery involves both sides of the groin. Participation can help improve future surgical care for individuals with similar conditions. As an unphased trial, this study provides a unique opportunity to contribute to valuable research that could enhance surgical outcomes for many patients.
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 these suture materials are safe for groin closure after vascular intervention?
Research has shown that both PDS and Vicryl stitches are generally safe for people. Studies on PDS stitches have found low rates of infections at the surgery site and other complications. One study found no deaths during surgeries using PDS, and doctors found it easy to use.
For Vicryl stitches, studies have identified some issues, such as wound infections, though these are not very common. Some reports noted increased swelling with Vicryl, but it is not severe for most people. Overall, both types of stitches are well-tolerated.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores different suture materials for closing groin access sites after vascular interventions. Unlike traditional sutures, this study compares PDS and Vicryl sutures, which may offer different benefits in terms of healing and tissue integration. By examining these materials, researchers hope to uncover insights into optimizing post-surgical outcomes and improving patient recovery times. This could lead to better wound closure techniques that enhance healing and reduce complications.
What evidence suggests that this trial's suture materials could be effective for groin closure after vascular intervention?
This trial will compare the effectiveness of different suture materials for groin closure after vascular intervention. Research has shown that polydioxanone (PDS) stitches, which participants in one arm of this trial may receive, perform well in blood vessel surgeries. They have a low risk of causing infection and swelling, potentially reducing post-surgery complications.
Participants in another arm of this trial will receive Vicryl stitches, which are also commonly used for wound closure. These stitches are strong and effectively hold tissues together. Some studies suggest they can lower the risk of infections at the surgery site. Both PDS and Vicryl have demonstrated positive results in surgeries.12367Who Is on the Research Team?
Francis Caputo, MD
Principal Investigator
The Cleveland Clinic
Are You a Good Fit for This Trial?
The CLOSM Trial is for individuals with vascular disease who have undergone or will undergo a vascular intervention requiring groin closure. Participants must be treated at the CCF main campus and willing to be randomly assigned to different suture materials. Specific inclusion and exclusion criteria details are not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo groin closure after vascular intervention using either Vicryl or PDS sutures
Follow-up
Participants are monitored for groin complications following the intervention
What Are the Treatments Tested in This Trial?
Interventions
- Groin Closure
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Cleveland Clinic
Lead Sponsor