Clinical trial • Phase III • Infectious Disease
GENTAMICIN for Infection | Surgical site infection | Breast implant infection
Phase III trial of GENTAMICIN for Infection | Surgical site infection | Breast implant infection.
Overview
- Trial Therapeutic Area
- Infectious Disease
- Trial Disease
- Infection | Surgical site infection | Breast implant infection
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 30-08-2024
- First CTIS Authorization Date
- 20-09-2024
Trial design
Randomised, placebo comparator: sodium chloride (natriumklorid fresenius kabi 9 mg/ml solution / sodium chloride) used as placebo (product entries present; routes indicated as topical/topical use).-controlled Phase III trial across 6 sites in Denmark.
- Randomised
- Yes
- Comparator
- Placebo comparator: Sodium chloride (Natriumklorid Fresenius Kabi 9 mg/ml solution / SODIUM CHLORIDE) used as placebo (product entries present; routes indicated as topical/topical use).
- Target Sample Size
- 1003
- Trial Duration For Participant
- 365
Eligibility
Recruits 1003 Vulnerable population selected. Participants are adults (Age ≥ 18 years) and biologically female. Signed informed consent is required; a subject information and informed consent form document is provided (document: "informed consent form and subject information"). No assent or alternative consent processes are specified..
- Pregnancy Exclusion
- Pregnancy
- Vulnerable Population
- Vulnerable population selected. Participants are adults (Age ≥ 18 years) and biologically female. Signed informed consent is required; a subject information and informed consent form document is provided (document: "informed consent form and subject information"). No assent or alternative consent processes are specified.
Inclusion criteria
- {"criterion_text":"- Age ≥ 18 years\n- Biologically female\n- Signed informed consent\n- Scheduled for breast reconstruction with implants or expanders including: a. Immediate or delayed reconstructions b. Bilateral or unilateral reconstructions c. With or without simultaneous flap reconstruction"}
Exclusion criteria
- {"criterion_text":"- Pregnancy\n- Breast feeding\n- Known allergy towards Vancomycin, Gentamicin and Cefazolin\n- Known anaphylactic reaction towards other beta-lactam antibiotics or aminoglycosides\n- Known allergy towards neomycin\n- Known impaired renal function with GFR < 60 mL/min\n- Participation in investigational drug trials and projects concerning disinfecting agents in the breast implant cavity\n- Myasthenia Gravis"}
Endpoints
Primary endpoints
- {"endpoint_text":"- All-cause explantation of the breast implant within 180 days after the breast reconstruction surgery","definition_or_measurement_approach":"All-cause explantation assessed within 180 days after the breast reconstruction surgery (binary event occurring within the 180-day follow-up period)."}
Secondary endpoints
- {"endpoint_text":"- Time to explantation (days)\n- All-cause explantation of the breast implant within 1 year after the breast reconstruction surgery (Y/N)\n- Revision surgery with incision of the fibrous capsule within 180 days after the breast reconstruction surgery (Y/N)\n- Exchange of permanent implant to expander implant within 180 days after the breast reconstruction surgery (Y/N)\n- Surgical site infection that leads to antibiotic treatment within 180 days after the breast reconstruction surgery (Y/N)\n- Infection-specific revision surgery: Revision surgery due to clinically suspected deep surgical site infection with surgical access to the breast implant pocket or clinical signs of an infection in the breast implant pocket found intraoperatively within 180 days after the breast reconstruction surgery (Y/N)","definition_or_measurement_approach":"Time-to-event measured in days for explantation; binary outcomes (Y/N) assessed within specified time windows (180 days or 1 year) as stated for each secondary endpoint; infection-specific revision defined as revision surgery due to clinically suspected deep surgical site infection with surgical access to the implant pocket or intraoperative signs of infection."}
Recruitment
- Planned Sample Size
- 1003
- Recruitment Window Months
- 72
- Consent Approach
- Signed informed consent required from each participant (participants are adults ≥18 years). A subject information and informed consent form document is provided (document title: "informed consent form and subject information", version 2.3). No languages or assent procedures are specified in the record.
Geography
- Total Number Of Sites
- 6
- Total Number Of Participants
- 1003
Denmark
- Earliest CTIS Part Ii Submission Date
- 12-09-2024
- Latest Decision Or Authorization Date
- 20-09-2024
- Processing Time Days
- 8
- Number Of Sites
- 6
- Number Of Participants
- 1003
Sites
- Site Name
- Rigshospitalet
- Department Name
- Plastic Surgery and Burns Treatment
- Contact Person Name
- Mikkel Herly
- Contact Person Email
- mikkel.herly@regionh.dk
- Site Name
- Roskilde Hospital
- Department Name
- Plastic Surgery
- Contact Person Name
- Nicco Krezdorn
- Contact Person Email
- nkre@regionsjaelland.dk
- Site Name
- Herlev Hospital
- Department Name
- Plastic Surgery
- Contact Person Name
- Lisbet Hölmich
- Contact Person Email
- lisbet.rosenkrantz.hoelmich@regionh.dk
- Site Name
- Aalborg University Hospital
- Department Name
- Plastic Surgery
- Contact Person Name
- Lene Birk-Sørensen
- Contact Person Email
- l.birksoerensen@rn.dk
- Site Name
- Aarhus Universitetshospital
- Department Name
- Plastic Surgery
- Contact Person Name
- Julie Allen
- Contact Person Email
- juli.alle@auh.rm.dk
- Site Name
- Odense University Hospital
- Department Name
- Plastic Surgery
- Contact Person Name
- Camilla Bille
- Contact Person Email
- camilla.bille@rsyd.dk
Sponsor
Primary sponsor
- Full Name
- Rigshospitalet
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Denmark
Third parties
- {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsor duties (code: 1); contact email: gcp-enheden.bispebjerg-frederiksberg-hospitaler@regionh.dk","organisation_type":"Hospital/Clinic/Other health care facility"}
Investigational products
- Investigational Product Name
- GENTAMICIN
- Active Substance
- GENTAMICIN
- Modality
- Small molecule
- Routes Of Administration
- Topical
- Route
- Topical
- Authorisation Status
- Authorised
- Maximum Dose
- 80 mg
- Investigational Product Name
- VANCOMYCIN
- Active Substance
- VANCOMYCIN
- Modality
- Small molecule
- Routes Of Administration
- Topical
- Route
- Topical
- Authorisation Status
- Authorised
- Maximum Dose
- 1 g
- Investigational Product Name
- CEFAZOLIN
- Active Substance
- CEFAZOLIN SODIUM
- Modality
- Small molecule
- Routes Of Administration
- Topical
- Route
- Topical
- Authorisation Status
- Authorised
- Maximum Dose
- 1 g
- Investigational Product Name
- SODIUM CHLORIDE (placebo)
- Active Substance
- SODIUM CHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- Topical
- Route
- Topical
- Authorisation Status
- Authorised
- Maximum Dose
- 500 ml (product entry: Natriumklorid Fresenius Kabi 9 mg/ml, maxTotalDoseAmount 500 ml)
- Combination Treatment
- Yes
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