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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.