iNPWT in Immediate Breast Reconstruction

Summary

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.

Conditions

• Breast Neoplasm Female
• Mammaplasty

Interventions

DEVICE

Prevena

Incisional negative pressure wound therapy (iNPWT), is a new approach for surgical site closure using negative pressure wound therapy (NPWT). Recently, PrevenaTM have been approved as an iNPWT-system applied at the end of surgery, while still in a sterile environment. PrevenaTM consist of a sponge foam with a bactericidal silver lining dressed with an adherent film, connected to a vacuum device, producing a vacuum of 125 mm Hg. The PrevenaTM foam and dressing is placed over the suture line, and is recommended to be kept in place for a continuous period lasting between 2 and 7 days.

OTHER

Standard Postoperative dressing

The standard postoperative dressing, using steri strips placed over the suture line.

Sponsors & Collaborators

• University of Aarhus

  lead OTHER

Principal Investigators

• Tine E Damsgaard, MD, Phd. · University of Aarhus and Aarhus University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-11-20

Primary Completion

2018-11-30

Completion

2019-04-30

Countries

• Denmark

Study Locations