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Deep Inferior Epigastric Artery Flap for Breast Reconstruction

NCT ID: NCT05088239

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-01

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer Perforator Flap Anti-Infectives Adverse Reaction Infections

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

prophylactic antibiotics duration

Intervention Type DRUG

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.

prophylactic antibiotics duration

Intervention Type DRUG

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.

prophylactic antibiotics duration

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

24 Years

Maximum Eligible Age

63 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chiayi Christian Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Chien-Liang Fang, Director

Role: STUDY_DIRECTOR

Ditmanson Medical Foundation Chia-Yi Christian Hospital, Chia-Yi City, Taiwan

Other Identifiers

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CYCH-IRB No.2020092

Identifier Type: -

Identifier Source: org_study_id