ClinicalTrials.gov
public full text
Public Domain
Pseudomonas Aeruginosa Injection Combined With Polyvinylpyrrolidone-Iodine in Immediate Breast Reconstruction Surgery With Implants
Brief Summary This study hypothesizes that in immediate breast reconstruction following tumor resection, the application of inactivated Pseudomonas aeruginosa preparation (PAP) may reduce infection rates by decreasing postoperative drainage output and shortening drainage tube removal time. Additionally, the local aseptic inflammation induced by PAP may promote fibrous capsule formation around the implant, shorten postoperative shaping time, and improve patients' quality of life and satisfaction. To test this hypothesis, the investigators designed a study to evaluate the efficacy of PAP compared with PI/TAB irrigation alone. Primary endpoints include drainage tube removal time and capsular contracture rate (assessed by Baker grade). Secondary endpoints include infection rate, total drainage volume, and postoperative BREAST-Q scores. Different concentrations of PAP will also be evaluated to determine the optimal therapeutic concentration. Detailed Description Postoperative infection rates in breast implant procedures range from 1% to 35%. Infection necessitates antibiotic treatment, may lead to unnecessary reoperations, and contributes to patient dissatisfaction. Inflammation and infection around the implant can promote biofilm formation, leading to capsular contracture (CC) following breast implant surgery. In patients undergoing breast reconstruction after tumor resection, postoperative infection may also delay adjuvant cancer treatment. Consequently, various antimicrobial irrigation solutions are routinely employed in immediate breast reconstruction after cosmetic surgery or tumor resection to reduce infection and CC rates, including 10% povidone-iodine (PI) and triple antibiotic solutions. PI irrigation was first introduced by Burkhardt et al. in the 1980s for cosmetic breast surgery, followed by the development of a broader-spectrum triple antibiotic solution (TAB) by Adams et al. In 2000, the FDA prohibited the use of PI with breast implants due to concerns
Conceptio Open Archive
Analyze & explore related research in Conceptio
Connect this record directly into your research workflow or AI agent. Explore citations across open repositories, query full text, and export structured proof bundles.
This document is indexed with metadata only: full text is not available in the archive for this record. Open the official source ↗
Related documents
- Effect of a Maintenance Protocol After Surgical Treatment of Peri-implantitis#829445
- A Study of an Antibiotic Implant in General Surgical Subjects at Higher Risk for Surgical Wound Infection#1056944
- Mechanical Treatment Peri-Implant Mucositis#827047
- Follow up Study of Patients Undergoing Total Hip Arthroplasty CERAFIT® Grafted With Poly Sodium Styrene Sulfonate#1073107
- Hand Hygiene and Hospital Acquired Infections#868214
Record · ID 827291
Retrieved via Conceptio: every document is proof-bundled with source, license, and retrieval metadata.
Retrieved via Conceptio: every document is proof-bundled with source, license, and retrieval metadata.
Bring this data into your agent: Connect via MCP or API · 20 free credits to start · no card required
Read the Docs → · View CLI source on GitHub · Conceptio Open Knowledge Archive
Read the Docs → · View CLI source on GitHub · Conceptio Open Knowledge Archive