Effectiveness of postoperative oral administration of cephalexin and metronidazole on surgical site infection among obese women undergoing cesarean section: a randomized, double-blind, placebo-controlled, parallel-group study-phase III.
Infant, Newborn
Female
Pregnancy
Humans
Surgical Wound Infection
/ prevention & control
Cephalexin
/ therapeutic use
Metronidazole
/ therapeutic use
Cesarean Section
/ adverse effects
Antibiotic Prophylaxis
/ methods
Cellulitis
/ drug therapy
Iran
Anti-Bacterial Agents
/ therapeutic use
Administration, Oral
Obesity
/ complications
Cephalexin
Cesarean section
Metronidazole
Obesity
Surgical site infection
Journal
Antimicrobial resistance and infection control
ISSN: 2047-2994
Titre abrégé: Antimicrob Resist Infect Control
Pays: England
ID NLM: 101585411
Informations de publication
Date de publication:
05 12 2022
05 12 2022
Historique:
received:
27
05
2022
accepted:
30
11
2022
entrez:
6
12
2022
pubmed:
7
12
2022
medline:
17
12
2022
Statut:
epublish
Résumé
Cesarean section (CS) is the most frequently performed surgery in the United States. Compared to vaginal delivery, CS has a higher risk of maternal and neonatal mortality, morbidities, and complications, among which surgical site infection (SSI) is the most common. We aimed at evaluating the effectiveness of postoperative oral administration of cephalexin and metronidazole on SSI among obese women undergoing CS. We conducted a randomized, double-blind clinical trial comparing the prophylactic effect of oral cephalexin and metronidazole vs cephalexin and placebo on SSI following CS among obese women. who had received preoperative prophylactic cephalosporin antibiotics. The study was conducted at the Ommolbanin Hospital, affiliated with Mashhad University of Medical Sciences from April 2019 to February 2020. The participants were randomized into the intervention group (n = 210) and the control group (n = 210). At week-1 follow-up, the outcomes were significantly lower in the intervention group as compared to the control group in terms of fever (9% vs 19%, p = 0.003), abnormal discharge from the incision (serous: 8.6% vs 10.5%, purulent: 2.9% vs 16.7%, p < 0.001), incision separation (1% vs 7.1%, p = 0.001), and cellulitis (4.8% vs 13.3%, p = 0.002). At week-2 follow-up, there were no patients in the intervention group with fever, abnormal discharge from the incision, incision separation, or cellulitis and there was a statistically significant difference for fever, abnormal discharge from the incision, and incision separation between the two groups (p < 0.001, p = 0.001, p = 0.014, respectively). Post-operative administration of cephalexin and metronidazole for 48-h post-cesarean delivery among obese women, in addition to the standard pre-operative prophylaxis, reduced the overall rate of surgical site infection and wound infection symptoms in a 2-week follow-up. Trial registration The study protocol was approved by the Iranian Registry of Clinical Trials (IRCTID: IRCT20200608047685N2) on 2021-03-15.
Sections du résumé
BACKGROUND
Cesarean section (CS) is the most frequently performed surgery in the United States. Compared to vaginal delivery, CS has a higher risk of maternal and neonatal mortality, morbidities, and complications, among which surgical site infection (SSI) is the most common. We aimed at evaluating the effectiveness of postoperative oral administration of cephalexin and metronidazole on SSI among obese women undergoing CS.
METHODS
We conducted a randomized, double-blind clinical trial comparing the prophylactic effect of oral cephalexin and metronidazole vs cephalexin and placebo on SSI following CS among obese women. who had received preoperative prophylactic cephalosporin antibiotics. The study was conducted at the Ommolbanin Hospital, affiliated with Mashhad University of Medical Sciences from April 2019 to February 2020.
RESULT
The participants were randomized into the intervention group (n = 210) and the control group (n = 210). At week-1 follow-up, the outcomes were significantly lower in the intervention group as compared to the control group in terms of fever (9% vs 19%, p = 0.003), abnormal discharge from the incision (serous: 8.6% vs 10.5%, purulent: 2.9% vs 16.7%, p < 0.001), incision separation (1% vs 7.1%, p = 0.001), and cellulitis (4.8% vs 13.3%, p = 0.002). At week-2 follow-up, there were no patients in the intervention group with fever, abnormal discharge from the incision, incision separation, or cellulitis and there was a statistically significant difference for fever, abnormal discharge from the incision, and incision separation between the two groups (p < 0.001, p = 0.001, p = 0.014, respectively).
CONCLUSION
Post-operative administration of cephalexin and metronidazole for 48-h post-cesarean delivery among obese women, in addition to the standard pre-operative prophylaxis, reduced the overall rate of surgical site infection and wound infection symptoms in a 2-week follow-up. Trial registration The study protocol was approved by the Iranian Registry of Clinical Trials (IRCTID: IRCT20200608047685N2) on 2021-03-15.
Identifiants
pubmed: 36471429
doi: 10.1186/s13756-022-01191-y
pii: 10.1186/s13756-022-01191-y
pmc: PMC9724355
doi:
Substances chimiques
Cephalexin
OBN7UDS42Y
Metronidazole
140QMO216E
Anti-Bacterial Agents
0
Banques de données
IRCT
['IRCT20200608047685N2']
Types de publication
Randomized Controlled Trial
Clinical Trial, Phase III
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
150Informations de copyright
© 2022. The Author(s).
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