Pseudomonas Aeruginosa Injection Combined With Polyvinylpyrrolidone-Iodine in Immediate Breast Reconstruction Surgery With Implants

NCT07460297 | Enrolling By Invitation DMC

• 1 other identifier: lnszl
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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 regarding higher contracture rates and potential degradation of silicone implants. Subsequent research by Adams et al. led to the development of a PI-free irrigation solution (TAB), which demonstrated comparable efficacy, albeit with slightly reduced coverage against Gram-negative bacteria. In August 2017, based on accumulated long-term data, the FDA lifted the restriction on PI use with implants, permitting its application for bacterial/biofilm mitigation and antimicrobial prophylaxis. Subsequent studies comparing the antimicrobial efficacy of PI and TAB have yielded mixed results, and a meta-analysis found no significant difference in CC rates between the two irrigation methods. However, the FDA withdrew bacitracin injections in 2020 due to safety concerns. As a result, standardization of antimicrobial irrigation solutions for implant-based immediate breast reconstruction remains lacking. Notably, immediate reconstruction following tumor resection differs fundamentally from cosmetic surgery. For instance, the 14-point plan for cosmetic breast surgery recommends avoiding drainage tubes, a practice often unfeasible in immediate reconstruction, where two drainage tubes are typically placed for 4-7 days postoperatively. Breast surgeons aim to minimize drainage tube duration owing to the increased risk of surgical site infection (SSI). In immediate reconstruction, capsule formation time is prolonged compared with augmentation surgery, potentially leading to implant displacement and contracture. PAP, derived from an inactivated PA-MSHA strain, has been shown by Long et al. to reduce postoperative drainage and shorten drainage tube removal time. PAP may also promote fibrous capsule formation, thereby reducing infection rates and improving patients' quality of life.

Conditions

Postoperative Seroma Rate, Drainage Tube Removal Time, and Capsular Contracture Rate; Seroma Following Procedure

Outcome Measures

Primary Outcomes (1)

• seroma rate

  postoperative seroma rate

  Within 30 days post-surgery

Study Arms (2)

PAP+PI group

EXPERIMENTAL

Using two to six vials of PAP preparation combined with 100ml of iodophor to soak the implant and irrigate the surgical cavity

Drug: Pseudomonas aeruginosa; Drug: Povidone-Iodine

PI group

PLACEBO COMPARATOR

Using 100ml of iodophor only to soak the implant and irrigate the surgical cavity

Drug: Povidone-Iodine

Interventions

Pseudomonas aeruginosa DRUG

Using two to six vials of PAP（Inactivated Pseudomonas aeruginosa injection） preparation combined with 100ml of iodophor to soak the implant and irrigate the surgical cavity.

PAP+PI group

Povidone-Iodine DRUG

100ml povidone-iodin

PAP+PI group; PI group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 and above
• Female
• Preoperative pathological confirmation of invasive breast cancer or ductal carcinoma in situ
• Clinical T1 and T2 (maximum tumor diameter ≤5 cm)
• Clinically negative axillary lymph nodes (clinical examination and ultrasound suggest negative axillary lymph nodes; fine needle aspiration is negative for suspected axillary lymph node abnormalities)
• No clinical or radiological evidence of distant metastasis
• Patients undergoing skin-sparing mastectomy or breast-conserving surgery - BMI \< 35
• Patients without lactational apoptosis or with mild breast apoptosis
• Implant volume \< 500 milliliters (11) Able and willing to sign the informed consent form (ICF)

You may not qualify if:

• Breast patients with moderate to severe breast development, or patients who require subcutaneous mastectomy using Wise mode or other breast lift methods
• Body mass index \>=35
• Patients who underwent symmetrical breast surgery immediately or later on the unaffected side
• Patients with locally advanced breast cancer receiving neoadjuvant therapy
• Patients who are currently participating in other clinical trials, which may have an impact on participation in this trial
• Neoadjuvant therapy has been completed, and there is a clear indication for adjuvant radiotherapy after surgery
• History of previous breast cancer (patients with ipsilateral recurrence after breast-conserving surgery)
• Pregnant and lactating women
• Smoking history
• History of previous diabetes mellitus

Sponsors & Collaborators

• Jianyi Li: lead

Study Sites (1)

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, 110000, China

Location

MeSH Terms

Interventions

Povidone-Iodine

Intervention Hierarchy (Ancestors)

Iodophors; Iodine Compounds; Inorganic Chemicals; Polyvinyls; Vinyl Compounds; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Povidone; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Plastics; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: March 10, 2026
• Study Start: April 16, 2025
• Primary Completion (Estimated): January 10, 2028
• Study Completion (Estimated): June 10, 2028
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

CN (1)