Negative pressure wound therapy does not decrease postoperative wound complications in patients undergoing mastectomy and flap fixation

L De Rooij, S M J van Kuijk, E R M van Haaren, A Janssen, Y L J Vissers, G L Beets, J van Bastelaar, L De Rooij, S M J van Kuijk, E R M van Haaren, A Janssen, Y L J Vissers, G L Beets, J van Bastelaar

Abstract

Patients and breast cancer surgeons are frequently confronted with wound complications after mastectomy. Negative pressure wound therapy (NPWT) is a promising technique for preventing wound complications after skin closure in elective surgery. However, a clinical study evaluating postoperative complications following the use of NPWT, focusing solely on closed incisions in patients undergoing mastectomy, has yet to be performed. Between June 2019 and February 2020, 50 consecutive patients underwent mastectomy with NPWT during the first seven postoperative days. This group was compared to a cohort of patients taking part in a randomized controlled trial between June 2014 and July 2018. Primary outcome was the rate of postoperative wound complications, i.e. surgical site infections, wound necrosis or wound dehiscence during the first three postoperative months. Secondary outcomes were the number of patients requiring unplanned visits to the hospital and developing clinically significant seroma (CSS). In total, 161 patients were analyzed, of whom 111 patients in the control group (CON) and 50 patients in the NPWT group (NPWT). Twenty-eight percent of the patients in the NPWT group developed postoperative wound complications, compared to 18.9% in the control group (OR = 1.67 (95% CI 0.77-3.63), p = 0.199). The number of patients requiring unplanned visits or developing CSS was not statistically significant between the groups. This study suggests that Avelle negative pressure wound therapy in mastectomy wounds does not lead to fewer postoperative wound complications. Additionally, it does not lead to fewer patients requiring unplanned visits or fewer patients developing clinically significant seromas.Trial registration: ClinicalTrials.gov number, NCT03942575. Date of registration: 08/05/2019.

Conflict of interest statement

The authors declare no competing interests.

References

1. 1. Van Bastelaar J, Theunissen LLB, Snoeijs M, Beets G, Vissers Y. Flap fixation using tissue glue or sutures appears to reduce seroma aspiration after mastectomy for breast cancer. Clin Breast Cancer. 2017;17(4):316–321. doi: 10.1016/j.clbc.2017.01.005.
2. 1. Ten Wolde B, van den Wildenberg FJ, Keemers-Gels ME, Polat F, Strobbe LJ. Quilting prevents seroma formation following breast cancer surgery: Closing the dead space by quilting prevents seroma following axillary lymph node dissection and mastectomy. Ann Surg Oncol. 2014;21:802–807. doi: 10.1245/s10434-013-3359-x.
3. 1. Van Bastelaar J, van Roozendaal L, Granzier R, Beets G, Vissers Y. A systematic review of flap fixation techniques in reducing seroma formation and its sequelae after mastectomy. Breast Cancer Res Treat. 2018;167(2):409–416. doi: 10.1007/s10549-017-4540-x.
4. 1. Gaston R, Kuremsky M, et al. Postoperative infections: Prevention and management. Hand Clin. 2010;26(2):265–280. doi: 10.1016/j.hcl.2010.01.002.
5. 1. World Health Organization. Global Guidelines for the Prevention of Surgical Site Infection, 2016. . Accessed 31 July 2020
6. 1. Jeffery S, Leaper D, Armstrong D, et al. Using negative pressure wound therapy to prevent surgical site infection. J. Wound Care. 2018;27(3):5–13. doi: 10.12968/jowc.2018.27.Sup3.S5.
7. 1. Scalise A, Calamita R, Tartaglione C. Improving wound healing and preventing surgical site complications of closed surgical incisions: A possible role of incisional negative pressure wound therapy. A systematic review of the literature. Int. Wound J. 2016;13:1260–1281. doi: 10.1111/iwj.12492.
8. 1. Sandy-Hodgetts K, Watts R. Effectiveness of negative pressure wound therapy/closed incision management in the prevention of post-surgical wound complications: A systematic review and meta-analysis. JBI Database Syst. Rev. Implement. Rep. 2015;13(1):1260–1281.
9. 1. Hyldig N, Birke-Sorensen H, Kruse M, et al. Meta-analysis of negative-pressure wound therapy for closed surgical incisions. Br. J. Surg. 2016;103(5):477–486. doi: 10.1002/bjs.10084.
10. 1. Strugala V, Martin R. Meta-analysis of comparative trials evaluating a prophylactic single-use negative pressure wound therapy system for the prevention of surgical site complications. Surg. Infect. (Larchmt) 2017;18(7):810–819. doi: 10.1089/sur.2017.156.
11. 1. Webster J, Liu Z, Norman G, Dumville JC, Chiverton L, Scuffham P, Stankiewicz M, Chaboyer WP. Negative pressure wound therapy for surgical wounds healing by primary closure. Cochrane Database Syst. Rev. 2019;3(3):CD009261.
12. 1. Semsarzadeh N, Tadisina K, Maddox J, et al. Closed incision negative-pressure therapy is associated with decreased surgical-site infections: A meta-analysis. Plast. Reconstr. Surg. 2015;136(3):592–602. doi: 10.1097/PRS.0000000000001519.
13. 1. Cagney D, Simmons L, O’Leary DP, Corrigan M, Kelly L, O’Sullivan MJ, Liew A, Redmond HP. The efficacy of prophylactic negative pressure wound therapy for closed incisions in breast surgery: A systematic review and meta-analysis. World J. Surg. 2020;44(5):1526–1537. doi: 10.1007/s00268-019-05335-x.
14. 1. Kostaras EK, Tansarli GS, Falagas ME. Use of negative-pressure wound therapy in breast tissues: Evaluation of the literature. Surg. Infect. (Larchmt) 2014;15:679–685. doi: 10.1089/sur.2013.165.
15. 1. Namdaroglu OB, Yazici H, Ozturk AM, et al. Negative-pressure wound therapy in chronic inflammatory breast diseases. J. Breast. Heal. 2016;12:91–93. doi: 10.5152/tjbh.2016.2908.
16. 1. Ferrando PM, Ala A, Bussone R, Bergamasco L, Actis Perinetti F, Malan F. Closed incision negative pressure therapy in oncological breast surgery. Plast. Reconstr. Surg. Glob. Open. 2018;6:e1732. doi: 10.1097/GOX.0000000000001732.
17. 1. Gabriel A, Sigalove S, Sigalove N, et al. The impact of closed incision negative pressure therapy on postoperative breast reconstruction outcomes. Plast. Reconstr. Surg. Glob. Open. 2018;6:e1880. doi: 10.1097/GOX.0000000000001880.
18. 1. Matusiak D, Wichtowski M, Pieszko K, Kobylarek D, Murawa D. Is negative-pressure wound therapy beneficial in modern-day breast surgery? Contemp. Oncol. (Pozn) 2019;23(02):69–73.
19. 1. Tanaydin V, Beugels J, Andriessen A, Sawor JH, van der Hulst RRWJ. Randomized controlled study comparing disposable negative-pressure wound therapy with standard care in bilateral breast reduction mammoplasty evaluating surgical site complications and scar quality. Aesthet. Plast. Surg. 2018;42:927–935. doi: 10.1007/s00266-018-1095-0.
20. 1. Galiano RD, Hudson D, Shin J, et al. Incisional negative pressure wound therapy for prevention of wound healing complications following reduction mammaplasty. Plast. Reconstr. Surg. Glob. Open. 2018;6:e1560. doi: 10.1097/GOX.0000000000001560.
21. 1. Van Bastelaar J, Granzier R, van Roozendaal LM, Beets G, Dirksen CD, Vissers Y. A multi-center, double blind randomized controlled trial evaluating flap fixation after mastectomy using sutures or tissue glue versus conventional closure: Protocol for the Seroma reduction After Mastectomy (SAM) trial. BMC Cancer. 2018;18(1):830. doi: 10.1186/s12885-018-4740-8.
22. 1. De Rooij, L. et al. Reducing seroma formation and its sequelae after mastectomy by closure of the dead space: A multi-center, double-blind randomized controlled trial (SAM-Trial). Ann. Surg. Oncol.28(5), 2599–2608 (2021).

Source: PubMed