Chloraprep for Surgical Antiseptic

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Sanford USD Medical Center, Sioux Falls, SD
Surgical Antiseptic+4 More
Chloraprep - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a surgical prep solution can reduce the rate of infection after surgery.

See full description

Eligible Conditions

  • Surgical Antiseptic
  • Surgical Site Infections
  • Bacterial Colonization
  • Lower Extremity Surgery

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether Chloraprep will improve 2 primary outcomes and 1 secondary outcome in patients with Surgical Antiseptic. Measurement will happen over the course of 14-21 days.

14-21 days
bacterial strain identification
positive culture rate
quantitative bacterial colonization

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

no reapplication
1 of 2
reapplication
1 of 2
Active Control
Experimental Treatment

This trial requires 140 total participants across 2 different treatment groups

This trial involves 2 different treatments. Chloraprep is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

reapplication
Drug
This group will have chloraprep reapplied following their lower extremity surgical procedure and prior to dressing application.
no reapplicationThis group will not have chloraprep reapplied after their surgery and prior to dressing application.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chlorhexidine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 14-21 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 14-21 days for reporting.

Who is running the study

Principal Investigator
K. J.
Kyle Judd, Employed Physician
Sanford Health

Closest Location

Sanford USD Medical Center - Sioux Falls, SD

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Male and female
Adults (18+)
Both elective and non-elective procedures
Lower extremity surgery performed below the knee and requiring post-operative splint immobilization for 2-3 weeks
Able to understand and read the English language
Signed informed consent

Patient Q&A Section

What causes surgical wound infection?

"Wound infection is a complex problem, and the bacterial spectrum of pathogens is constantly evolving. A thorough review of the literature may help practitioners identify and treat the bacterial infection that is causing infection. The most frequently isolated organisms in our hospital were P. aeruginosa, S. aureus, V. cholerae, MRSA, E. coli, Enteroccocus spp., MRCO, H. influenzae, K. pneumoniae, Salmonella spp., Klebsiella pneumoniae, E. coli, C. perfringens, V. albuae, E. coli, Stx-producing E. coli, E. cloacae, P. avium, B." - Anonymous Online Contributor

Unverified Answer

What is surgical wound infection?

"The development of SSI is characterized by a series of events that include the entrance of bacteria into the wound, the multiplication of bacteria by biofilms, and the interaction between pathogens and host tissues to cause infection. Clinicians must not only identify an infection or infection-like process, which may include fever of unknown origin, but also obtain samples for microbiologic cultures and antimicrobial sensitivity testing so that the clinician can select appropriate antimicrobial therapy. Early application of antibiotics to these wounds that appear infected should be implemented to diminish the chance of developing SSI." - Anonymous Online Contributor

Unverified Answer

How many people get surgical wound infection a year in the United States?

"A total of 8.2 million people develop surgical site infections, and around 100,000 of these cases result in death each year. Surgical site organisms represent a significant challenge for clinical practitioners and healthcare systems to tackle. These infections can impose a substantial burden on healthcare costs and incur significant medical, economic, and societal effects for those affected." - Anonymous Online Contributor

Unverified Answer

What are common treatments for surgical wound infection?

"Surgical wounds are extremely susceptible to contamination which leads to a substantial amount of surgical infection. One must be skilled with the techniques of cleanliness and handling of surgical instruments to prevent infection and wound dehiscence. Surgical wound infection is a major concern for surgeons and must be aggressively treated. Antibiotic therapy is highly recommended to prevent infection." - Anonymous Online Contributor

Unverified Answer

What are the signs of surgical wound infection?

"Signs often present as the first signs of infection rather than presenting as the infection itself, and include erythema of the skin, swelling, itchiness, warmth, and discharge. However, diagnosis is still often made when there are clear signs of infection, and this will improve the overall success of wound infection treatment." - Anonymous Online Contributor

Unverified Answer

Can surgical wound infection be cured?

"The use of antibiotics in the surgical setting was an effective prophylactic method for the prevention of surgical-site wound infection. Although antibiotics could not completely eradicate infection, our data did not suggest that antibiotics caused wound dehiscence in the study population. Further randomized trials are needed to validate our results and further define optimal use of antibiotics in surgical settings." - Anonymous Online Contributor

Unverified Answer

Does chloraprep improve quality of life for those with surgical wound infection?

"We found that the use of CCH reduces the need for a revision operation in patients with deep SSI. The use of CCH may therefore improve the quality of life of patients with SSI with an infected wound." - Anonymous Online Contributor

Unverified Answer

Has chloraprep proven to be more effective than a placebo?

"The use of chloraprep at the end of bowel preparation proved to be useful in preventing severe and late post-colonectomy infections in patients undergoing elective colorectal surgery." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of surgical wound infection?

"Surgical site infection and non-sterility can be due to different causes. This makes it hard to guess the cause of infections. Some infections with [potential of being due to sterile technique errors|sterile technique errors] have no definitive cause, and can therefore only be solved by proper implementation of guidelines. The remaining have a sterile solution but may be caused by the fact that they are not the exact cause. Some types are reversible or preventable. These and their remedies can be found in the surgical wound infections page of our website (https://www.surgicalwound-infections.com/)." - Anonymous Online Contributor

Unverified Answer

What is chloraprep?

"Chloraprep is a medication used to improve outcomes for people with diabetes when other treatments have failed and can be used by people with diabetes to manage their blood sugar. Chloraprep can be bought over the counter. The medication lasts longer than a calendar month. Chloraprep may make blood sugar levels better, improve blood cholesterol levels and triglyceride levels and improve blood glucose control. Chloraprep was discovered in 1965 and approved for sale in the United States in 2007. Chloraprep expired in 2009 in the United States. Chloraprep may be in the market as a product of a different manufacturer and with a different name. In 2005, the U.S." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving chloraprep?

"Because this study showed that chloraprep reduced surgical site infections (SSIs) compared to a control group, chloraprep could be a safe option if no other antibiotic is available for the patient." - Anonymous Online Contributor

Unverified Answer

What is the latest research for surgical wound infection?

"There were many articles regarding surgical skin and subcutaneous infections; most are nonclinical epidemiology studies and, therefore, not of high quality. The recent article by Bischoff and colleagues is a critical, high-quality study that highlights the critical need for improving the quality of the current research, particularly in the area of wound infection and treatment." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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