Deep Inferior Epigastric Artery Flap for Breast Reconstruction

NCT05088239 | Completed

• 1 other identifier: CYCH-IRB No.2020092
• Study Type: observational
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Breast Cancer; Perforator Flap; Anti-Infectives Adverse Reaction; Infections

Keywords

Prophylatic antibiotics; DIEP flap

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

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

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

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

Interventions

prophylactic antibiotics duration 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; PA3; PAD

Eligibility Criteria

• Age: 24 Years - 63 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Age \< 20 years old.

Sponsors & Collaborators

• Chiayi Christian Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms; Infections

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Chien-Liang Fang, Director

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 21, 2021
• Study Start: July 1, 2011
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share