Inflammatory Response to CSII Catheters in a Tummy Tuck Model

NACompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

February 1, 2018

Primary Completion Date

May 9, 2023

Study Completion Date

December 31, 2024

Conditions
Diabetes Mellitus
Interventions
DEVICE

Continous Subcutaneous Insulin Infusion Catheter

Catheters will be inserted into the abdomen of each patient using aseptic technique according to the following schedule: (1) 8 days before surgery, (2) 4 days before surgery and (3) 1 day before surgery (Table 1). At each time point 2 steel (Medtronic Sure-T, 9 mm) and 2 Teflon (Medtronic Quick-set®, 9 mm) CSII catheters will be inserted into the subcutaneous abdominal tissue. In total, 12 catheters will be inserted into each patient's abdomen using only the area predefined by the plastic surgeon for removal.

Trial Locations (1)

8036

Division of Plastic, Aesthetic and Reconstructive Surgery, Graz

All Listed Sponsors
lead

Medical University of Graz

OTHER

NCT03298295 - Inflammatory Response to CSII Catheters in a Tummy Tuck Model | Biotech Hunter | Biotech Hunter