Effects of Prostaglandin E1 on Skin Flap Necrosis in Immediate Implant Breast Reconstruction Following Total Skin-Sparing Mastectomy

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0002978

Enrollment

168

Registered

2018-07-04

Start date

2018-06-05

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : PGE1 (Alprostadil 10ug/2mL (Mitsubishi Tanabe Pharma Corp.) is administrated intravenously (10ug per day, mixed with normal saline 500cc) starting right after the surgery until postoperative da

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Patients who undertaken immediate implant-based breast reconstruction following skin-sparing mastectomy. 2. Patients who can understand the study and can decide to participate or not. 3. Female patients who are 19 years old or older.

Exclusion criteria

Exclusion criteria: 1. Patients who have past history of partial mastectomy or radiation therapy on the breast. 2. Patients who have major immediate postoperative complications which make the breast implant be removed. 3. Patients who are younger than 19 years old. 4. Patients with heart failure. 5. Patients who have bleeding tendency. 6. Patient who is pregnent. 7. Patient who has allergy to the drug (PGE1). 8. Patient who has allergy to bean or peanut. 9. Patient who has allergey to soybean oil.

Design outcomes

Primary

Measure	Time frame
Development of skin flap complications	—

Secondary

Measure	Time frame
Other postoperative complications including hematoam, infection, seroma, and reconstruction failures.	—

Countries

Korea, Republic of

Contacts

Public ContactKyong-Je Woo

Ewha Womans University Medical Center

economywoo@gmail.com+82-2-2650-5392

Outcome results