Deep Inferior Epigastric Artery Flap for Breast Reconstruction

Division of Plastic and Reconstruction Surgery

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.

Study Overview

• Status: Completed
• Conditions: Infections; Breast Cancer; Perforator Flap; Anti-Infectives Adverse Reaction
• Intervention / Treatment: Drug: prophylactic antibiotics duration

• Study Type: Observational
• Enrollment (Actual): 108

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 24 years to 63 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PAD; In prophylactic antibiotics for drain group (PAD) (n = 15), 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 for 10-14 days when the drains were removed from the breast and abdomen.	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.
PA3; In the 3-day prophylactic antibiotics group (PA3) (n = 11), prophylactic cefazolin 1000 mg was given 30 minutes before surgery, every 4 hours in peri-operative period, and 6-hourly thereafter for 3 days.	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.
PA1; In the 1-day prophylactic antibiotics group (PA1) (n = 82), patients received prophylactic cefazolin 1000 mg 30 minutes before surgery, every 4 hours in the peri-operative period, and every 6 hours in the post-operative period and antibiotics were discontinued within 24 hours of surgery.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Chiayi Christian Hospital
• Investigators: Study Director: Chien-Liang Fang, Director, Ditmanson Medical Foundation Chia-Yi Christian Hospital, Chia-Yi City, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2011
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: October 6, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (Actual): October 21, 2021

Study Record Updates

• Last Update Posted (Actual): October 21, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: DIEP flap; Prophylatic antibiotics
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: CYCH-IRB No.2020092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Prophylactic antibiotics discontinued within 24 hours after deep inferior epigastric perforator flap reconstruction can prevent surgical site infection occurrence.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No