iNPWT in Immediate Breast Reconstruction

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.

Sex

Female

Minimum age

18 Years

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.

• BACKGROUNDMeijers-Heijboer H, van Geel B, van Putten WL, Henzen-Logmans SC, Seynaeve C, Menke-Pluymers MB, Bartels CC, Verhoog LC, van den Ouweland AM, Niermeijer MF, Brekelmans CT, Klijn JG. Breast cancer after prophylactic bilateral mastectomy in women with a BRCA1 or BRCA2 mutation. N Engl J Med. 2001 Jul 19;345(3):159-64. doi: 10.1056/NEJM200107193450301. PMID 11463009
• BACKGROUNDSkytte AB, Cruger D, Gerster M, Laenkholm AV, Lang C, Brondum-Nielsen K, Andersen MK, Sunde L, Kolvraa S, Gerdes AM. Breast cancer after bilateral risk-reducing mastectomy. Clin Genet. 2011 May;79(5):431-7. doi: 10.1111/j.1399-0004.2010.01604.x. Epub 2011 Jan 4. PMID 21199491
• BACKGROUNDColwell AS, Damjanovic B, Zahedi B, Medford-Davis L, Hertl C, Austen WG Jr. Retrospective review of 331 consecutive immediate single-stage implant reconstructions with acellular dermal matrix: indications, complications, trends, and costs. Plast Reconstr Surg. 2011 Dec;128(6):1170-1178. doi: 10.1097/PRS.0b013e318230c2f6. PMID 22094736
• BACKGROUNDSalzberg CA, Ashikari AY, Koch RM, Chabner-Thompson E. An 8-year experience of direct-to-implant immediate breast reconstruction using human acellular dermal matrix (AlloDerm). Plast Reconstr Surg. 2011 Feb;127(2):514-524. doi: 10.1097/PRS.0b013e318200a961. PMID 21285756
• BACKGROUNDBollero D, Malvasio V, Catalano F, Stella M. Negative pressure surgical management after pathological scar surgical excision: a first report. Int Wound J. 2015 Feb;12(1):17-21. doi: 10.1111/iwj.12040. Epub 2013 Feb 19. PMID 23418720
• BACKGROUNDMorykwas MJ, Argenta LC, Shelton-Brown EI, McGuirt W. Vacuum-assisted closure: a new method for wound control and treatment: animal studies and basic foundation. Ann Plast Surg. 1997 Jun;38(6):553-62. doi: 10.1097/00000637-199706000-00001. PMID 9188970
• BACKGROUNDJacobs S, Simhaee DA, Marsano A, Fomovsky GM, Niedt G, Wu JK. Efficacy and mechanisms of vacuum-assisted closure (VAC) therapy in promoting wound healing: a rodent model. J Plast Reconstr Aesthet Surg. 2009 Oct;62(10):1331-8. doi: 10.1016/j.bjps.2008.03.024. Epub 2008 Jul 9.