Antibacterial Soap + Ointment for Wound Infection

Overseen By Faria Nusrat, BS

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: The Cooper Health System

Disqualifiers: Allergy to chlorhexidine, mupirocin, Staphylococcus infection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 1

848 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether using antibacterial soap and ointment before skin cancer surgery can prevent infections in open leg wounds. Researchers compare participants using Hibiclens soap (an antibacterial soap) and mupirocin ointment (an antibacterial ointment) with those who do not, to determine if these treatments reduce infections. It is ideal for adults scheduled for skin cancer surgery on their legs, particularly if their wound will heal naturally. As a Phase 3 trial, this study is the final step before FDA approval, allowing participants to contribute to a potentially groundbreaking treatment.

Do I need to stop 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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that using Hibiclens soap and mupirocin ointment is generally safe for surgical patients. This combination can help reduce infections, especially for those with certain bacteria in their nose. These treatments have been used together without major safety concerns.

Mupirocin ointment is applied inside the nostrils, and Hibiclens is used as a body wash. Moderate evidence supports their safety and effectiveness in preventing surgical infections. Some people might experience minor skin irritation or redness, but serious reactions are rare.

Since this trial is in a later stage, existing safety data supports the use of these products. Prospective participants should know that these treatments have been used safely in other patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using Hibiclens and mupirocin for wound infection prevention because these treatments offer a proactive approach to bacterial decolonization before surgery. Unlike standard options that typically focus on treating infections after they occur, this combination aims to prevent them by reducing bacterial presence on the skin and in the nasal passages. Hibiclens is an antiseptic skin cleanser that eradicates bacteria on the skin, while mupirocin ointment targets bacteria in the nose, both of which are common sources of surgical site infections. By addressing bacteria before surgery, this method has the potential to significantly lower infection rates, which is a promising advancement in surgical care.

What evidence suggests that this treatment might be an effective treatment for wound infection?

Research has shown that applying mupirocin ointment in the nostrils effectively removes Staphylococcus aureus, a common type of bacteria, from the nose. Studies have found that this can help reduce infections after surgery. Additionally, using an antiseptic body wash like Hibiclens can lower the chance of surface-level infections at the surgical site, though it might not prevent deeper infections. In this trial, one group will receive both mupirocin ointment and Hibiclens as a prophylactic treatment to reduce bacteria on the skin and in the nose, aiming to lower the risk of infection after surgery. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults who are having skin cancer surgery on their lower legs and will have wounds left open to heal. Participants should not already be using any antibacterial treatments before the surgery.

Inclusion Criteria

I am scheduled for skin cancer surgery on my legs and have no other surgeries planned soon after.

I am 18 years old or older.

My surgical wound will be left open to heal on its own.

Exclusion Criteria

I've had heart valve or joint replacement surgery and needed antibiotics before the operation.

Have a known allergy to chlorhexidine or mupirocin

Have a history of Staphylococcus aureus infection

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-operative Treatment

Participants in the treatment group apply Hibiclens and mupirocin for 5 days prior to surgery

1 week

No visits required

Surgery

Participants undergo skin cancer surgery and receive standard wound care instructions

1 day

1 visit (in-person)

Follow-up

Participants send pictures of their surgical site at 2-week and 4-week post-operation to monitor for signs of infection

4 weeks

Remote monitoring with potential in-person visit if infection is suspected

What Are the Treatments Tested in This Trial?

Interventions

• Bacterial Decolonization with Hibiclens and Mupirocin

Trial Overview The study tests if using Hibiclens soap and mupirocin ointment before surgery can reduce infection rates in open leg wounds post-surgery, compared to no pre-surgery treatment. The treated group uses these products for 5 days prior, while the control group does not.

How Is the Trial Designed?

Group I: Treatment Group Experimental Treatment 2 Interventions

This group will be prophylactically treated with topical antibiotics every day for 5 days prior to surgery. Participants will shower with Hibiclens antiseptic skin cleanser once daily and apply mupirocin ointment to the nares twice daily, in the morning and evening.

Group II: Control Group Active Control 1 Intervention

This group will NOT be prophylactically treated with Hibiclens antiseptic skin cleanser and mupirocin ointment prior to surgery.

Who Is Running the Clinical Trial?

The Cooper Health System

Lead Sponsor

Trials

82

Recruited

35,600+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

University of California, Davis

Collaborator

Trials

958

Recruited

4,816,000+

Baylor College of Medicine

Collaborator

Trials

1,044

Recruited

6,031,000+

Princeton Healthcare System

Collaborator

Trials

2

Recruited

30+

University of Georgia

Collaborator

Trials

109

Recruited

43,500+

St. Luke's Hospital and Health Network, Pennsylvania

Collaborator

Trials

17

Recruited

2,004,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10120916/

Preoperative bathing or showering with skin antiseptics to ... This review provides no clear evidence of benefit for preoperative showering or bathing with chlorhexidine over other wash products, to reduce surgical site ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26138660/

Effect of perioperative mupirocin and antiseptic body wash ... Mupirocin and antiseptic body wash reduced the rate of superficial but not deep or organ/space SSIs. Postoperative patient treatment may be critical.

3. cdn.who.int cdn.who.int/media/docs/default-source/integrated-health-services-(ihs)/ssi/evidence/appendix3.pdf?sfvrsn=5e78dae0_2

WHO Surgical Site Infection Prevention Guidelines Overall, a moderate quality of evidence shows that the use of mupirocin 2% ointment in combination with or without CHG body wash in surgical patients with nasal ...

4. aricjournal.biomedcentral.com aricjournal.biomedcentral.com/articles/10.1186/s13756-017-0202-3

Patient engagement with surgical site infection prevention A panel of experts evaluated options for patient involvement in order to provide pragmatic recommendations for pre-, intra- and postoperative activities for ...

5. esmed.org esmed.org/MRA/mra/article/view/3476

Nasal Decolonization to Reduce Surgical Site Infections Mupirocin remains the best topical agent at eradicating nasal Staphylococcus aureus. Mupirocin has been shown to eliminate nasal colonization by ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK536431/

Global Guidelines for the Prevention of Surgical Site Infection Moderate quality evidence shows that the use of mupirocin 2% ointment with or without a combination of CHG body wash in surgical patients with S. aureus nasal ...

7. withpower.com withpower.com/trial/phase-3-surgical-wound-infection-2-2023-da1be

Antibacterial Soap + Ointment for Wound Infection Trial Overview The study tests if using Hibiclens soap and mupirocin ointment before surgery can reduce infection rates in open leg wounds post-surgery, ...

8. nejm.org nejm.org/doi/full/10.1056/NEJMoa0808939

Preventing Surgical-Site Infections in Nasal Carriers ... Patients were randomly assigned in a 1:1 ratio to either active treatment with mupirocin ointment 2% (Bactroban, GlaxoSmithKline) in combination ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8763364/

Topical antibiotic prophylaxis for surgical wound infections in ... This study is a systematic review and meta-analysis designed to compare the efficacy and safety of topical antibiotics with non-antibiotic agents in preventing ...