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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05088239
Other study ID # CYCH-IRB No.2020092
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2011
Est. completion date December 31, 2020

Study information

Verified date October 2021
Source Chiayi Christian Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background: There is no consensus on the duration of prophylactic antibiotics for autologous breast reconstruction after mastectomy. We try to standardize prophylactic antibiotics use during breast reconstruction with deep inferior epigastric perforator flap following mastectomy. Methods: This retrospective case series involved 108 patients who underwent immediate breast reconstruction with deep inferior epigastric perforator flap in Ditmanson Medical Foundation Chia-Yi Christian Hospital between 2012 and 2019. Patients were divided into three groups based on prophylactic antibiotic duration: 1 day, 3 days and >7 days for patients with drains Data were analyzed between January and April, 2021.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date December 31, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender Female
Age group 24 Years to 63 Years
Eligibility Inclusion Criteria: - This retrospective study involved 108 patients who underwent immediate DIEP flap breast reconstruction after unilateral or bilateral mastectomy at the Ditmanson Medical Foundation Chia-Yi Christian Hospital between 2012 and 2019. Exclusion Criteria: - Age < 20 years old.

Study Design


Intervention

Drug:
prophylactic antibiotics duration
Prophylactic cefazolin 1000 mg was given 30 minutes before surgery, every 4 hours in the peri-operative period, and every 6 hours in the post-operative care. Different discontinued duration of antibiotics was divided to 3 groups in one day, 3 days and until to drain removal.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chiayi Christian Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary surgical site infection (SSI) Infection rate of surgical wounds of breast and abdomen. Patients were then followed up in the outpatient department for 1 year.
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