ciNPT in Autologous DIEP Flap Breast Reconstruction

Launched by MCMASTER UNIVERSITY · Jun 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different types of dressings applied to the surgical site after breast reconstruction surgery using the DIEP flap technique. The trial aims to find out if a new dressing called ciNPT can help reduce the risk of wound problems, known as wound dehiscence, compared to standard tape dressings. Women who have had a mastectomy for breast cancer and are planning to have this type of reconstruction may be eligible to participate. To qualify, participants must be adult females aged 18 or older, and they should not be pregnant or have any allergies to adhesive dressings. Additionally, women with a very high body weight (BMI of 40 or more) are excluded.

If you choose to participate, you will be randomly assigned to receive either the ciNPT dressing or the standard tape dressing after your surgery. The main goal is to see how well each dressing works in preventing complications at the surgical site one month after the operation. The study will also look at other outcomes, such as the presence of fluid buildup, infections, and how you feel about your recovery and scar appearance at different times post-surgery. Overall, this trial will help improve care for women undergoing breast reconstruction by determining which dressing is more effective in supporting their healing process.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • adult female patients (≥ 18 years old)
• • consent to elective immediate (i.e. performed at the time of mastectomy) or delayed (i.e. performed following mastectomy) breast reconstruction using the DIEP flap
• Exclusion Criteria:
• • patients who are pregnant
• • have a documented/reported allergy to adhesive dressings
• • Body mass index (BMI) ≥ 40 kg/m2