iNPWT in Immediate Breast Reconstruction

NCT03069885 | Unknown DMC

• 1 other identifier: 52373
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Drain time

  Time to removal of surgical drains.

  1-14 days after surgery

Secondary Outcomes (5)

• Surgical site infection

  1-30 days after surgery

• Skin necrosis

  1-30 days after surgery

• Hospitalization time

  1-30 days after surgery

• Patient and observer assessment of the scars

  4 weeks and 4 month after surgery

• Patient satisfaction and quality of Life

  1 week before surgery until 4 months after surgery

Study Arms (2)

Standard postoperative dressing group

ACTIVE COMPARATOR

30 patients treated with conventional post-operative dressing.

Other: Standard Postoperative dressing

Prevena group

EXPERIMENTAL

30 patients treated with PrevenaTM (incisional negative pressure wound therapy)

Device: Prevena

Interventions

Prevena DEVICE

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.

Prevena group

Standard Postoperative dressing OTHER

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

Standard postoperative dressing group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital, NBG

Aarhus, 8000, Denmark

Location

Related Publications (21)

• Meijers-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 BACKGROUND

• Skytte 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 BACKGROUND

• Colwell 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 BACKGROUND

• Salzberg 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 BACKGROUND

• Bollero 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 BACKGROUND

• Morykwas 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 BACKGROUND

• Jacobs 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.

  PMID: 18617451 BACKGROUND

• Argenta LC, Morykwas MJ. Vacuum-assisted closure: a new method for wound control and treatment: clinical experience. Ann Plast Surg. 1997 Jun;38(6):563-76; discussion 577.

  PMID: 9188971 BACKGROUND

• Saxena V, Hwang CW, Huang S, Eichbaum Q, Ingber D, Orgill DP. Vacuum-assisted closure: microdeformations of wounds and cell proliferation. Plast Reconstr Surg. 2004 Oct;114(5):1086-96; discussion 1097-8. doi: 10.1097/01.prs.0000135330.51408.97.

  PMID: 15457017 BACKGROUND

• Greene AK, Puder M, Roy R, Arsenault D, Kwei S, Moses MA, Orgill DP. Microdeformational wound therapy: effects on angiogenesis and matrix metalloproteinases in chronic wounds of 3 debilitated patients. Ann Plast Surg. 2006 Apr;56(4):418-22. doi: 10.1097/01.sap.0000202831.43294.02.

  PMID: 16557076 BACKGROUND

• Gomoll AH, Lin A, Harris MB. Incisional vacuum-assisted closure therapy. J Orthop Trauma. 2006 Nov-Dec;20(10):705-9. doi: 10.1097/01.bot.0000211159.98239.d2.

  PMID: 17106382 BACKGROUND

• Stannard JP, Volgas DA, McGwin G 3rd, Stewart RL, Obremskey W, Moore T, Anglen JO. Incisional negative pressure wound therapy after high-risk lower extremity fractures. J Orthop Trauma. 2012 Jan;26(1):37-42. doi: 10.1097/BOT.0b013e318216b1e5.

  PMID: 21804414 BACKGROUND

• Chadi SA, Kidane B, Britto K, Brackstone M, Ott MC. Incisional negative pressure wound therapy decreases the frequency of postoperative perineal surgical site infections: a cohort study. Dis Colon Rectum. 2014 Aug;57(8):999-1006. doi: 10.1097/DCR.0000000000000161.

  PMID: 25003295 BACKGROUND

• Llanos S, Danilla S, Barraza C, Armijo E, Pineros JL, Quintas M, Searle S, Calderon W. Effectiveness of negative pressure closure in the integration of split thickness skin grafts: a randomized, double-masked, controlled trial. Ann Surg. 2006 Nov;244(5):700-5. doi: 10.1097/01.sla.0000217745.56657.e5.

  PMID: 17060762 BACKGROUND

• Kilpadi DV, Cunningham MR. Evaluation of closed incision management with negative pressure wound therapy (CIM): hematoma/seroma and involvement of the lymphatic system. Wound Repair Regen. 2011 Sep-Oct;19(5):588-96. doi: 10.1111/j.1524-475X.2011.00714.x.

  PMID: 22092797 BACKGROUND

• Wilkes RP, Kilpad DV, Zhao Y, Kazala R, McNulty A. Closed incision management with negative pressure wound therapy (CIM): biomechanics. Surg Innov. 2012 Mar;19(1):67-75. doi: 10.1177/1553350611414920. Epub 2011 Aug 25.

  PMID: 21868417 BACKGROUND

• Kostaras EK, Tansarli GS, Falagas ME. Use of negative-pressure wound therapy in breast tissues: evaluation of the literature. Surg Infect (Larchmt). 2014 Dec;15(6):679-85. doi: 10.1089/sur.2013.165.

  PMID: 24871230 BACKGROUND

• Doig GS, Simpson F. Randomization and allocation concealment: a practical guide for researchers. J Crit Care. 2005 Jun;20(2):187-91; discussion 191-3. doi: 10.1016/j.jcrc.2005.04.005.

  PMID: 16139163 BACKGROUND

• Pusic AL, Klassen AF, Scott AM, Klok JA, Cordeiro PG, Cano SJ. Development of a new patient-reported outcome measure for breast surgery: the BREAST-Q. Plast Reconstr Surg. 2009 Aug;124(2):345-353. doi: 10.1097/PRS.0b013e3181aee807.

  PMID: 19644246 BACKGROUND

• van de Kar AL, Corion LU, Smeulders MJ, Draaijers LJ, van der Horst CM, van Zuijlen PP. Reliable and feasible evaluation of linear scars by the Patient and Observer Scar Assessment Scale. Plast Reconstr Surg. 2005 Aug;116(2):514-22. doi: 10.1097/01.prs.0000172982.43599.d6.

  PMID: 16079683 BACKGROUND

• Kim SY, Lim SY, Mun GH, Bang SI, Oh KS, Pyon JK. Evaluating the effectiveness of cryopreserved acellular dermal matrix in immediate expander-based breast reconstruction: a comparison study. Arch Plast Surg. 2015 May;42(3):316-20. doi: 10.5999/aps.2015.42.3.316. Epub 2015 May 14.

  PMID: 26015887 BACKGROUND

Related Links

• NORDCAN (Association of the Nordic Cancer Registries). Cancer stat fact sheets Denmark - Breast. 2015.
• DBCG (Danish Breast Cancer Cooperative Group)-retningslinier 2010 - Kapitel 19: Genetisk udredning, rådgivning og molekylærgenetisk analyse. 2010.

Study Officials

• Tine E Damsgaard, MD, Phd.

  University of Aarhus and Aarhus University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study will not be blinded, since the PrevenaTM-device makes a sound, when generating negative pressure, and the dressing looks a lot different compared to the conventional post-operative dressing.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The project is conducted as a randomized controlled trial. Patients included in the study will be randomized to either conventional post-operative dressing or PrevenaTM iNPWT treatment. Patients are allocated in a 1:1 ratio, with 30 patients treated with PrevenaTM and 30 patients treated with conventional post-operative dressing.

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: March 3, 2017
• Study Start: November 20, 2017
• Primary Completion: November 1, 2018
• Study Completion: April 1, 2019
• Last Updated: May 2, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)