Antiseptic Decolonization for Surgical Site Infections

(DECREASE SSI Trial)

Recruiting at 3 trial locations

Overseen By Raveena Singh, MA

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of California, Irvine

Must not be taking: Systemic antibacterials

Disqualifiers: Acute care, Hospice, Allergies, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

2700 Participants Needed

Trial Summary

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

The trial protocol does not specify if you need to stop taking your current medications. However, if you have an active infection requiring systemic antibacterial agents, you may be excluded from participating.

What data supports the idea that Antiseptic Decolonization for Surgical Site Infections is an effective treatment?

The available research shows that using antiseptic treatments like chlorhexidine and mupirocin can help reduce surgical site infections. In one study, patients who used chlorhexidine had a lower infection rate (9%) compared to those who used regular soap (12.8%) or placebo (11.7%). Another study found that mupirocin nasal ointment was effective in reducing the presence of bacteria in the nose, which can lead to infections, although it did not significantly lower the overall infection rate. Additionally, a trial combining nasal antiseptic with chlorhexidine baths significantly decreased infection rates by 81%. These findings suggest that antiseptic decolonization can be an effective treatment for reducing surgical site infections. ^{1 2 3 4 5}

What safety data exists for antiseptic treatments in surgical site infections?

The safety data for antiseptic treatments like chlorhexidine and mupirocin in surgical site infections includes several studies. A placebo-controlled trial with chlorhexidine showed a lower infection rate (9%) compared to bar soap (12.8%) and placebo (11.7%). A study on mupirocin nasal ointment showed effective eradication of Staphylococcus aureus nasal carriage but did not significantly reduce surgical site infection rates. Antibacterial soap with triclocarban was well tolerated and improved skin conditions in atopic dermatitis patients. However, there are concerns about intrinsic contamination of antiseptics during manufacturing, which can lead to healthcare-associated infections. ^{1 2 6 7 8}

Is the treatment Placebo Nasal Ointment, Soap Without Antiseptic Properties a promising treatment for preventing surgical site infections?

The treatment Placebo Nasal Ointment, Soap Without Antiseptic Properties is not considered promising for preventing surgical site infections. Research shows that using antiseptic treatments, like alcohol-based nasal antiseptics and chlorhexidine baths, significantly reduces infection rates. Placebo treatments, which lack these antiseptic properties, do not offer the same benefits. ^{3 5 9 10 11}

What is the purpose of this trial?

The DECREASE SSI Trial (Decolonization to Reduce After-Surgery Events of Surgical Site Infection) is a two-arm multi-center individual placebo-controlled randomized (2,700 participants randomized 1:1) clinical trial to reduce post-discharge surgical site infection following open colon or small bowel surgery by comparing chlorhexidine bathing plus nasal mupirocin in the 30 days following discharge to soap without antiseptic properties (placebo) and placebo nasal ointment. This trial seeks to enhance the care of the 675,000 patients annually who undergo colon and small bowel surgery by finding simple and efficacious interventions to reduce SSI.

Research Team

Susan Huang, MD, MPH

Principal Investigator

University of California, Irvine

Deborah Yokoe, MD, MPH

Principal Investigator

University of California, San Francisco

Stuart Cohen, MD

Principal Investigator

University of California, Davis

Eligibility Criteria

This trial is for adults who've had recent open surgery on their colon or small bowel, can bathe themselves or have help doing so, and are able to talk on the phone. It's not for those with an active infection at enrollment, unclosed surgical incisions, transferred to acute care hospitals post-surgery, discharged more than 14 days after surgery, in end-of-life hospice care, or allergic to mupirocin/chlorhexidine.

Inclusion Criteria

I can bathe myself or have someone to help me.

I can make regular phone calls.

I had recent open surgery involving my abdomen or a C-section with a BMI ≥ 40.

Exclusion Criteria

Discharged to receive end-of-life hospice measures

Allergic to mupirocin and/or chlorhexidine

I do not have an active infection needing antibiotics at enrollment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either chlorhexidine bathing plus nasal mupirocin or placebo for 30 days following discharge

4 weeks

Follow-up

Participants are monitored for surgical site infection and other outcomes after treatment

4 weeks

Treatment Details

Interventions

• 2% Mupirocin
• 4% Chlorhexidine Gluconate
• Placebo Nasal Ointment
• Soap Without Antiseptic Properties (Placebo)

Trial Overview The DECREASE SSI Trial is testing if bathing with chlorhexidine and using nasal mupirocin for 30 days after discharge can reduce infections compared to using regular soap (placebo) and placebo nasal ointment in patients who've undergone certain bowel surgeries.

Participant Groups

Group I: Decolonization Active Control 2 Interventions

Participants randomized into this arm will perform decolonization using topical antiseptic soap (chlorhexidine body wash) and an antibiotic ointment (nasal mupirocin).

Group II: Routine Care Placebo Group 2 Interventions

Participants randomized into this arm will perform routine care using soap without antiseptic properties (placebo) and placebo nasal ointment.

Placebo Nasal Ointment is already approved in United States, European Union for the following indications:

Approved in United States as Placebo Nasal Ointment for:

• Clinical trial control substance

Approved in European Union as Placebo Nasal Ointment for:

• Clinical trial control substance

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

Hoag Memorial Hospital Presbyterian

Collaborator

Trials

37

Recruited

17,200+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

University of California, Davis

Collaborator

Trials

958

Recruited

4,816,000+

University of Massachusetts, Amherst

Collaborator

Trials

83

Recruited

3,474,000+

Findings from Research

In a study of 1989 patients, preoperative washing with chlorhexidine significantly reduced the overall incidence of postoperative wound infections to 9%, compared to 12.8% with bar soap and 11.7% with a placebo.

For 'clean' surgeries, chlorhexidine further decreased the infection rate to 7.2%, and specifically reduced Staphylococcus aureus infections to 3%, highlighting its efficacy in preventing infections compared to traditional washing methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A placebo-controlled trial of the effect of two preoperative baths or showers with chlorhexidine detergent on postoperative wound infection rates. Hayek, LJ., Emerson, JM., Gardner, AM.[2019]

In a study involving 614 patients, mupirocin nasal ointment was highly effective in eradicating Staphylococcus aureus nasal carriage, achieving an eradication rate of 83.5% compared to 27.8% in the placebo group.

Despite the successful eradication of nasal carriage, mupirocin did not significantly reduce the overall rate of surgical site infections (SSIs) or the length of hospital stays, indicating that while it may help with nasal carriage, it does not necessarily prevent SSIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical site infections in orthopedic surgery: the effect of mupirocin nasal ointment in a double-blind, randomized, placebo-controlled study. Kalmeijer, MD., Coertjens, H., van Nieuwland-Bollen, PM., et al.[2013]

Nasal decolonization using mupirocin combined with chlorhexidine body wash significantly reduces the incidence of S. aureus-related surgical site infections in patients who are carriers, particularly in various surgical procedures, indicating its efficacy as a targeted intervention.

Universal nasal decolonization is more cost-effective than targeted approaches, potentially saving the healthcare system approximately $45.08 million over five years, while targeted decolonization may increase costs despite its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-surgical Nasal Decolonization of Staphylococcus aureus: A Health Technology Assessment. [2022]

In a study of 120 patients undergoing nasal surgery, the use of xylometazoline hydrochloride 0.1% nasal spray did not provide better symptom relief compared to sterile physiological saline aerosol.

Patients using xylometazoline reported significantly higher pain scores post-operatively, suggesting that it may not be a safe or effective option for managing symptoms after nasal surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Xylometazoline hydrochloride 0.1 per cent versus physiological saline in nasal surgical aftercare: a randomised, single-blinded, comparative clinical trial. Humphreys, MR., Grant, D., McKean, SA., et al.[2015]

Implementing a comprehensive nasal decolonization protocol, which included a nonantibiotic alcohol-based antiseptic and chlorhexidine, significantly reduced surgical site infection rates in spine surgery patients by 81%.

The trial lasted 15 months and showed a decrease in infection rates from 1.76 to 0.33 per 100 surgeries, highlighting the effectiveness of this combined approach in improving patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative participation of orthopedic patients and surgical staff in a nasal decolonization intervention to reduce Staphylococcus spp surgical site infections. Mullen, A., Wieland, HJ., Wieser, ES., et al.[2022]

In a 9-week double-blind study involving 50 patients with moderately severe atopic dermatitis, daily bathing with an antibacterial soap containing 1.5% triclocarban significantly improved skin lesions compared to a placebo soap.

The use of the antibacterial soap not only led to clinical improvements but also reduced the levels of Staphylococcus aureus and total aerobic organisms on the skin, indicating its efficacy in managing atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of antibacterial soap with 1.5% triclocarban on Staphylococcus aureus in patients with atopic dermatitis. Breneman, DL., Hanifin, JM., Berge, CA., et al.[2013]

Many skin antiseptics used in healthcare settings are sold as nonsterile and can be contaminated with harmful microorganisms, potentially leading to healthcare-associated infections.

There is a need to include skin antiseptics in antibiotic stewardship programs to mitigate the risk of contamination and the development of antimicrobial resistance, especially in hospitalized patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Skin antiseptics in healthcare facilities: is a targeted approach necessary? Wiemken, TL.[2020]

Olanexidine gluconate demonstrated superior bactericidal efficacy compared to chlorhexidine and povidone-iodine when applied to blood-contaminated skin, making it a promising option for preoperative skin preparation.

In non-blood-contaminated conditions, olanexidine's effectiveness was comparable to that of established antiseptics, indicating its potential as a reliable antiseptic for surgical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of olanexidine gluconate on preoperative skin preparation: an experimental study in cynomolgus monkeys. Nakata, H., Tsubotani, Y., Nii, T., et al.[2019]

Pre-operative decolonization with octenidine (OCT) did not significantly reduce overall surgical site infection (SSI) rates in patients undergoing elective coronary artery bypass graft (CABG) surgery, with rates of 15.4% in the control group and 13.3% in the intervention group.

However, the intervention significantly lowered the rate of harvest site SSIs (2.5% vs 0.5%) and organ/space sternal SSIs (1.9% vs 0.3%), indicating some targeted benefits of OCT in specific infection types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of pre-operative octenidine nasal ointment and showering on surgical site infections in patients undergoing cardiac surgery. Reiser, M., Scherag, A., Forstner, C., et al.[2021]

Implementing preoperative universal nasal and skin decolonization using an alcohol-based nasal antiseptic and chlorhexidine bathing significantly reduced surgical site infection rates after total joint replacement procedures.

This intervention not only decreased patient morbidity but also lowered healthcare costs associated with treating infections, highlighting its efficacy and potential benefits in surgical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A safer, less costly SSI prevention protocol-Universal versus targeted preoperative decolonization. Franklin, S.[2021]

Nasal decontamination significantly reduces the risk of surgical site infections (SSIs) in Staphylococcus aureus carriers, particularly in patients undergoing pulmonary surgeries, based on a review of 20 randomized controlled trials involving over 10,500 patients.

Chlorhexidine was found to be effective in decreasing SSI rates (RR = 0.474), while mupirocin did not show a significant benefit, indicating that the choice of decontamination method can impact surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasal decolonization of Staphylococcus aureus and the risk of surgical site infection after surgery: a meta-analysis. Tang, J., Hui, J., Ma, J., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

A placebo-controlled trial of the effect of two preoperative baths or showers with chlorhexidine detergent on postoperative wound infection rates. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Surgical site infections in orthopedic surgery: the effect of mupirocin nasal ointment in a double-blind, randomized, placebo-controlled study. [2013]

3. Canada pubmed.ncbi.nlm.nih.gov

Pre-surgical Nasal Decolonization of Staphylococcus aureus: A Health Technology Assessment. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Xylometazoline hydrochloride 0.1 per cent versus physiological saline in nasal surgical aftercare: a randomised, single-blinded, comparative clinical trial. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Perioperative participation of orthopedic patients and surgical staff in a nasal decolonization intervention to reduce Staphylococcus spp surgical site infections. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

The effect of antibacterial soap with 1.5% triclocarban on Staphylococcus aureus in patients with atopic dermatitis. [2013]

7. England pubmed.ncbi.nlm.nih.gov

Skin antiseptics in healthcare facilities: is a targeted approach necessary? [2020]

8. England pubmed.ncbi.nlm.nih.gov

Effects of olanexidine gluconate on preoperative skin preparation: an experimental study in cynomolgus monkeys. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Effect of pre-operative octenidine nasal ointment and showering on surgical site infections in patients undergoing cardiac surgery. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

A safer, less costly SSI prevention protocol-Universal versus targeted preoperative decolonization. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Nasal decolonization of Staphylococcus aureus and the risk of surgical site infection after surgery: a meta-analysis. [2021]