cephalexin & metronidazole for Surgical Wound Infection

1
Effectiveness
1
Safety
The Univeristy Hospital, Cincinnati, OH
Surgical Wound Infection+3 More
cephalexin & metronidazole - Drug
Eligibility
Any Age
Female
Eligible conditions
Surgical Wound Infection

Study Summary

This study is evaluating whether a prolonged course of antibiotics can prevent wound infection complications in obese patients who undergo cesarean section.

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Eligible Conditions

  • Surgical Wound Infection
  • Communicable Diseases
  • Infections
  • Surgical Site Infection in Obese Women Undergoing C-section

Treatment Effectiveness

Study Objectives

This trial is evaluating whether cephalexin & metronidazole will improve 1 primary outcome and 1 secondary outcome in patients with Surgical Wound Infection. Measurement will happen over the course of 6 weeks post partum.

6 weeks post partum
Febrile morbidity; Urinary tract infection; Endometritis
6weeks post partum
Surgical site infection

Trial Safety

Trial Design

2 Treatment Groups

Placebo/standard of care
Cephalexin and metronidazole
Placebo group

This trial requires 475 total participants across 2 different treatment groups

This trial involves 2 different treatments. Cephalexin & Metronidazole is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Cephalexin and metronidazole
Drug
500 mg cephalexin per oral every 8 hours for total of 6 doses; 500 mg metronidazole per oral every 8 hours for total of 6 doses
Placebo/standard of care
Drug
Placebo pills per oral every 8 hours for total of 6 doses

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6weeks post partum
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 6weeks post partum for reporting.

Who is running the study

Principal Investigator
R. M. P.
Rose Maxwell Ph.D., Director of Clinical Research
University of Cincinnati

Closest Location

The Univeristy Hospital - Cincinnati, OH

Eligibility Criteria

This trial is for female patients of any age. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
BMI > 30kg/m*2
Delivery via cesarean section
consent to participate
age 13 or older

Patient Q&A Section

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

What are the signs of surgical wound infection?

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Signs of surgical site infection include persistent purulent drainage, pain and erythema. The presence of bacteria can be suspected based on symptoms and signs of infection, however, further testing may reveal the presence of pathogens.

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What causes surgical wound infection?

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There are many possible reasons for why surgical sartorial infection occurs. These vary between individuals (in terms of patient features and the nature of the surgery). The risk factors for incisional surgical wound infection also vary between the different surgical procedures. Most procedures that cause incisional surgical site infection have some risk factors in common, including age >50 years, diabetes mellitus, ASA score ≥3, prior antibiotic use, and surgical delay. The reasons for surgical site infection can be determined in the operating theatre or within 48 hours of the procedure. Infection of intravascular devices and cerebrospinal fluid shunts may prolong the hospitalization period.

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

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There is still much we do not know. Infection occurs in approximately 5% of surgical procedures in the US, and the rate is highest for procedures that involve skin-to-skin contact. Most of these cases are bacterial and may be prevented if the patient practices simple measures during surgery.

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Can surgical wound infection be cured?

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Surgical wounds are frequently superficial and have a low risk for developing a surgical site infection. The main risk factors for developing a wound infection include the patient's age, comorbidity, obesity, diabetes, chronic obstructive pulmonary disease, and poor general health status. The wounds should be treated with a combination of antibiotics, in addition to washing the infected wound with normal saline, debridement with or without irrigation, dressing changes, and removal of necrotic tissue.

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What is surgical wound infection?

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Surgical wound infection is a severe complication that usually affects surgical patients. The mortality rate is very high, especially those who are infected in the thoracic, abdominal, and/or pelvic space.

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What are common treatments for surgical wound infection?

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Various treatment regimens are used to manage surgical wound infection that is caused by bacterial infection. These regimens may include the use of topical antibiotics, use of prophylactic antibiotics, or surgical drainage. If the surgical wound infection appears to be caused by MRSA, antibiotics are not effective against MRSA. Prophylactic antibiotics can be effective against MRSA when used on the time of surgery, but this is often deferred. Surgery is indicated for patients that do not have adequate healing of the wound, which may result from prophylactic antibiotics, a surgical drain, or a combination of both approaches.

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What are the common side effects of cephalexin & metronidazole?

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It was found that cephalexin, metronidazole, and combination of antibiotic (both of which may be used in the treatment of CVC-related bloodstream infections) had a statistically significant decrease in the number of infections and, consequently, in the length of stay of intensive care unit (ICU) patients in the ICU.

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Have there been other clinical trials involving cephalexin & metronidazole?

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There have been other small studies of cephalexin and metronidazole combined using either a single therapy or a combination (either as a single therapy or in contrast with a placebo or penicillin). The purpose of these studies was to compare single-therapy and double-therapy regimens for the treatment of pelvic inflammatory diseases and urinary tract infections. However, many of these studies were not controlled and some of the treatment arms used antibiotics at random intervals rather than in a predetermined fashion. Therefore, it is impossible to make a definitive prediction of the treatment response that will be obtained in a future clinical trial.

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Who should consider clinical trials for surgical wound infection?

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Clinicians should consider the patient's willingness to participate in a clinical trial on the basis of the severity and extent of the underlying illness and surgeons should consider using clinical trials when indicated.

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Have there been any new discoveries for treating surgical wound infection?

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There seems to be a trend for the use of antibiotic-impregnated surgical dressings to prevent wound infection in the post operative period. The effectiveness and safety of surgical dressings remains unknown. The choice between silver, nitrile, polypropylene and polyester, both in terms of their antimicrobial and wound healing capability, and their risk of allergic responses and allergy associated disorders are unknown. The evidence was inconclusive to say whether and what proportion of all types of dressings are best worn. There were no trials of silver containing dressings for surgical wound infections. The use of antimicrobial cotton sheeting as a topical antiseptic dressing has been tested and a Cochrane review is underway.

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How does cephalexin & metronidazole work?

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A synergistic effect on microbial sensitivity to cephalexin is noted for both Enterobacteriaceae isolates and H-2-P-like Enterococci. The clinical significance of such synergism needs to be further studied.

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Is cephalexin & metronidazole typically used in combination with any other treatments?

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Antibiotic combination with cephalexin and metronidazole is the standard first line therapy for uncomplicated surgical wounds with no indication for their use with antimicrobials like piperacillin, metronidazole or cefoxetine in addition. The antimicrobials listed in our paper either does not provide an advantage in comparison to cephalexin and metronidazole or cannot be used as alternative with other antimicrobials.

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