Single-Dose Antibiotics for Preventing Surgical Site Infections

Overseen By Mariana Phillips, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Carilion Clinic

Must not be taking: Antibiotics

Disqualifiers: Mental impairment, Pregnancy, Recent prosthetic, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

1600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a single dose of the antibiotic Cephalexin can prevent infections at skin surgery sites, such as the nose, ear, or lower leg. The study compares taking an antibiotic pill before surgery to taking a placebo (a harmless pill with no active medicine) to determine which better prevents infections. Individuals undergoing specific skin repair surgeries who haven't recently taken antibiotics might be suitable for this trial. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial requires that you stop taking any antibiotics within 48 hours before the surgery. Other medications are not mentioned, so it's best to discuss with the trial team.

What is the safety track record for these treatments?

Research shows that cephalexin, one of the antibiotics under study, is usually well-tolerated. It is often used during surgeries to prevent infections and is considered safe for most patients. Cephalexin is frequently chosen even for patients with certain allergies because it typically doesn't cause serious side effects.

In contrast, clindamycin, another antibiotic option for those allergic to cephalexin, carries a bit more risk. Some studies have found that clindamycin can increase the chance of infections at the surgery site in certain cases. It can also cause severe inflammation of the colon, which is rare but serious. Therefore, clindamycin is usually reserved for more serious infections when other drugs are unsuitable.

Both antibiotics have FDA approval for treating infections, indicating they are generally safe. This phase 4 trial aims to provide more information about their safety and effectiveness in preventing infections after surgery. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the potential of single-dose antibiotics like cephalexin for preventing surgical site infections because they offer a simplified approach compared to the standard multi-dose regimens. Unlike the traditional antibiotics that require multiple doses over several days, this treatment involves just one dose administered shortly before surgery, potentially improving patient compliance and reducing the risk of antibiotic resistance. Additionally, for patients with allergies to cephalexin, clindamycin hydrochloride is used as an alternative, ensuring broader patient applicability. This streamlined method could make managing post-surgical infection risks easier and more efficient.

What evidence suggests that this trial's treatments could be effective for preventing surgical site infections?

This trial will evaluate the effectiveness of single-dose antibiotics in preventing surgical site infections. Participants may receive Cephalexin, which studies have shown can significantly reduce the risk of infections at surgical sites. In one study, 12.5% of patients who took Cephalexin developed an infection, compared to 35.7% of those who took a placebo. For participants allergic to Cephalexin, Clindamycin serves as an alternative. Research shows that Clindamycin also reduces bacteria, which is crucial for preventing infections. Both antibiotics have shown promise in keeping surgical areas clean and free from infection. ^{1 6 7 8 9}

Who Is on the Research Team?

Mariana Phillips, MD

Principal Investigator

Carilion Clinic Dermatology and Mohs Surgery

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need certain skin surgeries at Carilion Clinic Dermatology in Roanoke, VA. It's for those getting skin flap or graft on the nose, ear repairs, or Mohs surgery below the knee. People with other conditions that could interfere are not eligible.

Inclusion Criteria

I am expected to have a one-time nose surgery involving skin repair.

I am expected to have a one-time ear surgery involving skin grafts or reshaping.

I am having or had skin surgery below the knee.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of preoperative antibiotic or placebo prior to dermatologic surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for surgical site infections for 30 days after surgery

4-5 weeks

1-2 visits (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Cephalexin
• Placebo capsules

Trial Overview The study tests if a single dose of an antibiotic (Cephalexin or Clindamycin) before surgery can prevent infections better than a placebo. Patients are randomly given either the real drug or a fake pill without knowing which one they received.

How Is the Trial Designed?

Group I: Antibiotic- nose Experimental Treatment 1 Intervention

The administration time of the oral antibiotics will be 5-15 minutes prior to surgery on the nose. 4-500 mg capsules of cephalexin will be administered to the patient. If there is concern for previous allergy to cephalexin, 4-150 mg capsules of clindamycin hydrochloride will be administered PO.

Group II: Antibiotic- leg Experimental Treatment 1 Intervention

The administration time of the oral antibiotics will be 30 minutes prior to incision in the leg group. 4-500 mg capsules of cephalexin will be administered to the patient. If there is concern for previous allergy to cephalexin, 4-150 mg capsules of clindamycin hydrochloride will be administered

Group III: Antibiotic- ear Experimental Treatment 1 Intervention

The administration time of the oral antibiotics will be 5-15 minutes prior to surgery on the ear. 4-500 mg capsules of cephalexin will be administered to the patient. If there is concern for previous allergy to cephalexin, 4-150 mg capsules of clindamycin hydrochloride will be administered PO.

Group IV: Placebo - leg Placebo Group 1 Intervention

If randomized to placebo group, 4 placebo capsules will be administered PO 30 minutes prior to incision in the leg group.

Group V: Placebo- nose Placebo Group 1 Intervention

If randomized to placebo group, 4 placebo capsules will be administered PO 5-15 minutes prior to surgery on the nose.

Group VI: Placebo- ear Placebo Group 1 Intervention

If randomized to placebo group, 4 placebo capsules will be administered PO 5-15 minutes prior to surgery on the ear.

Who Is Running the Clinical Trial?

Carilion Clinic

Lead Sponsor

Trials

85

Recruited

15,400+

Published Research Related to This Trial

A single intravenous dose of ceftriaxone (1 or 2 g) administered one hour before elective surgery was highly effective, achieving a therapeutic success rate of 92% in a study of 100 surgical patients.

This study supports the use of ceftriaxone as a short-term antimicrobial prophylaxis to prevent infections in surgical patients, highlighting its efficacy in a clinical setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Short-term antibiotic prophylaxis with ceftriaxone in general surgery]. La Rosa, M., Pagano, D., Cancelliere, M., et al.[2013]

Ceftibuten is the most effective oral cephalosporin against Enterobacteriaceae that produce plasmid-encoded broad spectrum beta-lactamases, outperforming several other antibiotics.

In a pharmacodynamic model, ceftibuten demonstrated bactericidal activity against Haemophilus influenzae and Streptococcus pneumoniae at concentrations similar to those achieved in human serum after a 200 mg oral dose taken twice daily.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ceftibuten and bactericidal kinetics. Comparative in vitro activity against Enterobacteriaceae producing extended spectrum beta-lactamases. Bauernfeind, A.[2019]

The study found that administering prophylactic antibiotics before surgery significantly reduced the occurrence of surgical site infections (SSIs), with only one infection in the group that received antibiotics compared to three infections in the group that did not.

Patients who received preoperative antibiotics had a shorter average hospital stay (38.5 hours) compared to those who did not receive antibiotics (57.3 hours), indicating both safety and efficacy of the antibiotic prophylaxis in surgical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use of Antibiotics for the Prevention of Surgical Site Infections in Two Government Hospitals in Taif, Saudi Arabia: A Retrospective Study. Alsaeed, OM., Bukhari, AA., Alshehri, AA., et al.[2022]

In a study of 838 adult patients undergoing cardiac surgery, a single dose of cefazolin was found to be less effective than a 24-hour regimen in preventing surgical site infections, with infection rates of 8.3% versus 3.6%, respectively.

Despite the higher infection rate with single-dose cefazolin, there were no significant differences in mortality or hospitalization duration between the two groups, indicating that while single-dose may be less effective, it does not impact overall patient outcomes in terms of survival or length of stay.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative study of single-dose and 24-hour multiple-dose antibiotic prophylaxis for cardiac surgery. Tamayo, E., Gualis, J., Flórez, S., et al.[2013]

In a study of 401 patients with acute localized skin or soft tissue infections, both ofloxacin and cephalexin demonstrated similar high rates of microbiologic cure, with 93.4% for ofloxacin and 94.0% for cephalexin.

Ofloxacin was found to be as effective as cephalexin in clinical outcomes, with 85.2% of patients showing clinical cure or improvement, while also being well tolerated, although it had a slightly higher rate of drug-related adverse effects (7.9% vs. 4.8% for cephalexin).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ofloxacin versus cephalexin for treating skin and soft tissue infections. Lipsky, BA., Yarbrough, DR., Walker, FB., et al.[2019]

In two randomized studies involving 343 patients, cephalexin hydrochloride was found to be as effective as cephalexin monohydrate for treating skin and soft tissue infections, with high response rates of 95.7% and 96.5% respectively.

Both formulations demonstrated a similar safety profile, with only 4.95% of patients experiencing adverse events, indicating that cephalexin hydrochloride is a safe and effective option for these infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative study of cephalexin hydrochloride and cephalexin monohydrate in the treatment of skin and soft tissue infections. Kumar, A., Murray, DL., Hanna, CB., et al.[2021]

In a study of 52 patients undergoing lower limb skin lesion excision, a single 2 g dose of cephalexin given before surgery showed a reduction in surgical site infections (SSI) from 35.7% in the placebo group to 12.5% in the cephalexin group, indicating a potential benefit of the antibiotic.

Although the results suggested a 65% relative reduction in infection rates, the study was underpowered to definitively confirm this effect, highlighting the need for further research to establish the efficacy of cephalexin in preventing SSIs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of surgical site infection in lower limb skin lesion excisions with single dose oral antibiotic prophylaxis: a prospective randomised placebo-controlled double-blind trial. Smith, SC., Heal, CF., Buttner, PG.[2022]

In a study involving 221 patients undergoing elective colorectal surgery, amoxycillin-clavulanic acid and cefotetan were found to have similar efficacy in preventing postoperative infections, with failure rates of 10% and 13% respectively.

The trial demonstrated that both antibiotics are effective prophylactic options, as there was no significant difference in infection rates between the two groups (P = 0.63), indicating that either can be safely used for this purpose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-dose amoxycillin-clavulanic acid vs. cefotetan for prophylaxis in elective colorectal surgery: a multicentre, prospective, randomized study. The PRODIGE Group. Arnaud, JP., Bellissant, E., Boissel, P., et al.[2019]

In a study using Swiss-Webster mice, both single and multiple doses of cefazolin significantly reduced wound bacterial concentrations and infection rates compared to a control group, indicating its effectiveness in preventing wound infections.

Cefonicid, despite its extended half-life, did not show superior efficacy over a single dose of cefazolin, suggesting that cefazolin is a cost-effective option for surgical prophylaxis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Duration of antibiotic prophylaxis. An experimental study. Scher, KS., Wroczynski, AF., Jones, CW.[2019]

A single 1g dose of cefotaxime was found to be more effective than multiple-dose regimens in preventing surgical wound infections, particularly in clean and clean-contaminated surgeries, with fewer infections reported (p < 0.05) when excluding colorectal procedures.

Patients receiving single-dose cefotaxime experienced significantly fewer adverse reactions (p < 0.001) and lower costs compared to traditional multiple-dose regimens, confirming its safety, efficacy, and economic advantage for surgical prophylaxis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cefotaxime single-dose surgical prophylaxis in a prepaid group practice. Comparisons with other cephalosporins and ticarcillin/clavulanic acid. Jones, RN., Slepack, JM., Wojeski, WV.[2018]

In a study of 1128 total hip and knee arthroplasties, patients receiving cefazolin had significantly lower rates of surgical site infections (SSIs) compared to those receiving clindamycin or vancomycin (0.9% vs 3.8%).

The use of cefazolin did not result in a higher frequency of interoperative hypersensitivity reactions compared to clindamycin or vancomycin, suggesting it is a safe option for patients labeled as beta-lactam allergic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cefazolin vs Second-line Antibiotics for Surgical Site Infection Prevention After Total Joint Arthroplasty Among Patients With a Beta-lactam Allergy. Norvell, MR., Porter, M., Ricco, MH., et al.[2023]

Cefazolin is associated with fewer adverse events and lower rates of surgical site infections compared to alternative antibiotics used for surgical prophylaxis, highlighting its efficacy and safety.

In a study of perioperative inpatients across 100 U.S. hospitals, patients with a documented β-lactam allergy were significantly less likely to receive cefazolin, while clindamycin was much more frequently prescribed, indicating a potential shift in antibiotic choice despite cefazolin's advantages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of β-Lactam Allergy Documentation and Prophylactic Antibiotic Use in Surgery: A National Cross-Sectional Study of Hospitalized Patients. Bertram, CM., Postelnick, M., Mancini, CM., et al.[2021]

Citations

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Prevention of surgical site infection in lower limb skin ... Results Incidence of SSI was 12.5% (95% CI 2.7% to 32.4%) in the cephalexin group compared with 35.7% (95% CI 18.6% to 55.9%) in the placebo group (p=0.064) ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36471429/

Effectiveness of postoperative oral administration ... We aimed at evaluating the effectiveness of postoperative oral administration of cephalexin and metronidazole on SSI among obese women undergoing CS.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2352587824000172

Efficacy of 24 hours versus 5 days of prophylactic ... 204 patients met the inclusion criteria: 104 in the 5-day group and 100 in the 24-hour prophylaxis group. The overall infection rate was 3.4%: 3% in the 24-hour ...

4. aricjournal.biomedcentral.com aricjournal.biomedcentral.com/articles/10.1186/s13756-022-01191-y

Effectiveness of postoperative oral administration of ... Our results showed that postoperative administration of cephalexin and metronidazole significantly reduced wound infection symptoms, including ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4160501/

What are the Patterns of Prophylactic Postoperative Oral ... Most surgeons preferred cephalexin 500 mg four times a day, and the duration most commonly was 5 to 7 days. Staphylococcus species is the most commonly isolated ...

6. ashp.org ashp.org/surgical-guidelines

Clinical Practice Guidelines for Antimicrobial Prophylaxis in ... The optimal time for admin- istration of preoperative doses is within 60 minutes before surgical incision. This is a more-specific time frame than the ...

7. med.stanford.edu med.stanford.edu/content/dam/sm/bugsanddrugs/documents/clinicalpathways/SHC-Surgical-Prophylaxis-ABX-Guideline.pdf

SHC Surgical Antimicrobial Prophylaxis Guideline Cefazolin is the drug of choice for MOST procedures and is safe to use for most patients with allergies (including anaphylaxis) to penicillin, ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S240585722200119X

Review Article Prophylactic antibiotics and Postoperative ... This meta-analysis evaluated the effect of AP on the risk of SSIs and adverse events (AE) of AP in clean and clean/contaminated cutaneous surgical procedures.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9364272/

The Use of Antibiotics for the Prevention of Surgical Site ... The use of preoperative prophylactic antibiotics significantly reduces the development of surgical site infections and the mean length of ...