Breast Neoplasm Female Clinical Trial
Official title:
Incisional Negative Pressure Wound Therapy (Prevena™) vs. Conventional Post-operative Dressing After Immediate Breast Reconstruction; a Randomized Controlled Clinical Trial
Verified date | May 2018 |
Source | University of Aarhus |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 60 |
Est. completion date | April 2019 |
Est. primary completion date | November 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
60 patients admitted for immediate breast reconstruction at the Department of Plastic
Surgery, Aarhus University Hospital, will upon informed consent be offered participation in
this prospective, randomized study using two types of post-operation dressing after the
breast reconstruction surgery. Inclusion Criteria: - Patient deemed best suited with an immediate breast reconstruction using implant by the consultant plastic- and breast surgeon. - Patient is older than 18 years of age. - Patient understand enough Danish to comprehend the given information and to complete the study questionnaires. Exclusion Criteria: - Current smokers (patients not having paused for a minimum of four weeks prior to surgery) - Non-eligible patients, as assessed by the operating surgeon - High level of co-morbidity, as assessed by operating surgeon or anaesthesiologist - Allergic to band-aids. |
Country | Name | City | State |
---|---|---|---|
Denmark | Aarhus University Hospital, NBG | Aarhus |
Lead Sponsor | Collaborator |
---|---|
University of Aarhus |
Denmark,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Drain time | Time to removal of surgical drains. | 1-14 days after surgery | |
Secondary | Surgical site infection | Post-operative surgical site infection rate | 1-30 days after surgery | |
Secondary | Skin necrosis | Rate of skin necrosis in relation to the breast reconstruction | 1-30 days after surgery | |
Secondary | Hospitalization time | Post-operation hospitalization time | 1-30 days after surgery | |
Secondary | Patient and observer assessment of the scars | The quality and appearance of the scar will be investigated at the post-operative clinical control by using the Patient and observer Scar Assessment Scale (POSAS). The POSAS is an instrument designed to measure scar quality. It consists of two scales, one completed by the patient and one completed by the observer | 4 weeks and 4 month after surgery | |
Secondary | Patient satisfaction and quality of Life | Patients included in the study will be asked to complete the BREAST-Q pre-reconstruction module before their breast reconstruction, and the BREAST-Q post-reconstruction module at the post-operative clinical control. The BREAST-Q is a patient reported outcome measure tool specifically designed and validated for use in breast reconstruction patients. | 1 week before surgery until 4 months after surgery |
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