Incisional Negative Pressure Wound Therapy (Prevena™) vs. Conventional Post-operative Dressing After Immediate Breast Reconstruction; a Randomized Controlled Clinical Trial

Due to the Danish breast cancer-screening programme and the increased use of genetic counselling, Danish women are being diagnosed with breast cancer, or a high lifetime risk of developing breast cancer, at a younger age than previously. An increasing proportion of these women pursue an immediate breast reconstruction, where the breast is removed and reconstructed in a single surgical procedure.

As some of these women will need to undergo adjuvant cancer therapy after their breast surgery, fast recovery is essential in order for the adjuvant therapy not to be delayed. With the development of new surgical techniques, the complication rate to the immediate breast reconstructions has improved. However, wound-healing issues remain one of the most common complications to the surgery with the possibility of delaying the adjuvant therapy and diminish the aesthetic result.

Incisional negative pressure wound therapy (iNPWT), is a new approach for surgical site closure. Recently, iNPWT has shown promising results in lowering post-operative complications, including wound-healing issues, in other surgical settings. However, iNPWT has still not been studied in an immediate breast reconstructive setting.

The current randomized controlled clinical study will investigate if an iNPWT system, is able to provide women seeking an immediate breast reconstruction with faster healing and superior aesthetic results compared to the conventional post-operative wound dressings used today. The investigators plan to include 60 women, randomized in a 1:1 ratio between iNPWT or conventional wound dressing. The primary outcome measure is the time until removal of the surgical drains, which corresponds to the healing progression. Secondarily, complications to the surgery, assessment of the scar (measured using the Patient and Observer Scar Assessment Scale) and patient reported satisfaction with the reconstruction (assessed using the BREAST-Q questionnaire) will be performed. Included patients are examined pre-operatively, and at the routine controls at four weeks and four months post operatively.

The results from the current study will elucidate if iNPWT aids wound healing after immediate breast reconstruction, which would lead to fewer patients experiencing delays before their adjuvant therapy. Furthermore, the results from the aesthetic satisfaction will elucidate if iNPWT provides the patients with a better self-reported aesthetic result.