Skip to main content

Advertisement

Log in

Effects of Fibrin Sealant on Seroma Reduction for Patients with Breast Cancer Undergoing Axillary Dissection: Meta-Analysis of Randomized Controlled Trials

  • Breast Oncology
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Background

Seroma formation is common in patients with breast cancer after axillary dissection. Fibrin sealant, containing fibrinogen and thrombin, has been developed to improve wound healing. We conducted a systematic review and meta-analysis to evaluate the efficacy of fibrin sealants in reducing seroma among patients with breast cancer undergoing axillary dissection.

Methods

We searched the PubMed, EMBASE, and Cochrane Library databases for randomized controlled trials (RCTs) published up to April 2020. Pooled estimates of the outcomes were computed using a random-effects model. The primary outcomes were incidence and volume of seroma, while the secondary outcomes were volume and duration of drainage, incidence of infection, and length of hospital stay.

Results

We reviewed 23 RCTs that included 1640 patients. Compared with the control group, the fibrin sealant group had no significant differences in the incidence of seroma, length of hospital stay, or incidence of surgical site infection. Significant intergroup differences were discovered in lower volume of seroma (weighted mean difference [WMD] − 71.88, 95% confidence interval [CI] − 135.58 to − 8.19), volume of drainage (WMD − 73.24, 95% CI − 107.32 to − 39.15), and duration of drainage (WMD − 0.84, 95% CI − 1.50 to − 0.19).

Conclusions

Fibrin sealants provide limited benefits in reducing the volume of seroma and the volume and duration of drainage. Therefore, after shared decision making, surgeons may apply fibrin sealants to patients with breast cancer undergoing axillary dissection.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5
Fig. 6

Similar content being viewed by others

References

  1. Hashemi E, Kaviani A, Najafi M, Ebrahimi M, Hooshmand H, Montazeri A. Seroma formation after surgery for breast cancer. World J Surg Oncol. 2004;2:44.

    Article  PubMed  PubMed Central  Google Scholar 

  2. Roses DF, Brooks AD, Harris MN, Shapiro RL, Mitnick J. Complications of level I and II axillary dissection in the treatment of carcinoma of the breast. Ann Surg. 1999;230:194–201.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  3. Cipolla C, Fricano S, Vieni S, et al. Does the use of fibrin glue prevent seroma formation after axillary lymphadenectomy for breast cancer? A prospective randomized trial in 159 patients. J Surg Oncol. 2010;101:600–3.

    Article  PubMed  Google Scholar 

  4. Woodworth PA, McBoyle MF, Helmer SD, Beamer RL. Seroma formation after breast cancer surgery: incidence and predicting factors. Am Surg. 2000;66:444–50; discussion 450–1.

  5. Vasileiadou K, Kosmidis C, Anthimidis G, Miliaras S, Kostopoulos I, Fahantidis E. Cyanoacrylate adhesive reduces seroma production after modified radical mastectomy or quadrantectomy with lymph node dissection-a prospective randomized clinical trial. Clin Breast Cancer. 2017;17:595–600.

    Article  CAS  PubMed  Google Scholar 

  6. Chaturvedi P, Chaturvedi U. Axillary compression with delayed drain removal reduces prolonged seroma formation. J Surg Oncol. 2001;78:279–80.

    Article  CAS  PubMed  Google Scholar 

  7. Galatius H, Okholm M, Hoffmann J. Mastectomy using ultrasonic dissection: effect on seroma formation. Breast. 2003;12:338–41.

    Article  PubMed  Google Scholar 

  8. Rice DC, Morris SM, Sarr MG, et al. Intraoperative topical tetracycline sclerotherapy following mastectomy: a prospective, randomized trial. J Surg Oncol. 2000;73:224–7.

    Article  CAS  PubMed  Google Scholar 

  9. Talbot ML, Magarey CJ. Reduced use of drains following axillary lymphadenectomy for breast cancer. ANZ J Surg. 2002;72:488–90.

    Article  PubMed  Google Scholar 

  10. Spotnitz WD. Fibrin Sealant: The only approved hemostat, sealant, and adhesive: a laboratory and clinical perspective. ISRN Surg. 2014;2014:203943.

    Article  PubMed  PubMed Central  Google Scholar 

  11. Langer S, Guenther JM, DiFronzo LA. Does fibrin sealant reduce drain output and allow earlier removal of drainage catheters in women undergoing operation for breast cancer? Am Surg. 2003;69:77–81.

    PubMed  Google Scholar 

  12. Moore MM, Nguyen DHD, Spotnitz WD. Fibrin sealant reduces serous drainage and allows for earlier drain removal after axillary dissection: a randomized prospective trial. Am Surg. 1997;63:97–102.

    CAS  PubMed  Google Scholar 

  13. Sajid MS, Hutson KH, Rapisarda IF, Bonomi R. Fibrin glue instillation under skin flaps to prevent seroma‐related morbidity following breast and axillary surgery. Cochrane Database Syst Rev. 2013;(5):CD009557.

    Google Scholar 

  14. Turner EJ, Benson JR, Winters ZE. Techniques in the prevention and management of seromas after breast surgery. Future Oncol. 2014;10:1049–63.

    Article  PubMed  CAS  Google Scholar 

  15. Benevento R, Santoriello A, Pellino G, et al. The effects of low-thrombin fibrin sealant on wound serous drainage, seroma formation and length of postoperative stay in patients undergoing axillary node dissection for breast cancer. A randomized controlled trial. Int J Surg. 2014;12:1210–5.

    Article  PubMed  Google Scholar 

  16. Higgins JPT, Green S. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration; 2011. Available at: www.cochrane-handbook.org.

  17. Liberati A, Altman DG, Tetzlaff J, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ. 2009;339:b2700.

    Article  PubMed  PubMed Central  Google Scholar 

  18. Wan X. Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range. BMC Med Res Methodol. 2014;14:135.

    Article  PubMed  PubMed Central  Google Scholar 

  19. DerSimonian R, Laird N. Meta-analysis in clinical trials. Control Clin Trials. 1986;7:177–88.

    Article  CAS  PubMed  Google Scholar 

  20. Segura-Castillo JL, Estrada-Rivera O, Castro-Cervantes JM, Cortés-Flores AO, Velázquez-Ramírez GA, González-Ojeda A. Reducción del drenaje linfático posterior a mastectomía radical modificada con la aplicación de gel de fibrina. Cir Cir. 2005;73:345–50.

    PubMed  Google Scholar 

  21. Gioffere Florio MA, Mezzasalma F, Manganaro T, Pakravanan H, Cogliandolo A. L’impiego della colla di fibrina nella chirurgia del carcinoma della mammella. Giorn Chir. 1993;14:239–41.

    Google Scholar 

  22. Berger A, Tempfer C, Hartmann B, et al. Sealing of postoperative axillary leakage after axillary lymphadenectomy using a fibrin glue coated collagen patch: a prospective randomised study. Breast Cancer Res Treat. 2001;67:9–14.

    Article  CAS  PubMed  Google Scholar 

  23. Dinsmore RC, Harris JA, Gustafson RJ. Effect of Fibrin glue on lymphatic drainage after modified radical mastectomy: a prospetive ramdomized trial. Am Surg. 2000;66:982–5.

    CAS  PubMed  Google Scholar 

  24. El Nakeeb A. Influence of fibrin glue on seroma formation after modified radical mastectomy: a prospective randomized study. Breast J. 2009;15:671–2.

    Article  PubMed  Google Scholar 

  25. Gilly FN, François Y, Sayag-Beaujard AC, Glehen O, Brachet A, Vignal J. Prevention of lymphorrhea by means of fibrin glue after axillary lymphadenectomy in breast cancer: prospective randomized trial. Eur Surg Res. 1998;30:439–43.

    Article  CAS  PubMed  Google Scholar 

  26. Fawzy A, Gaber A, Farid AAM. Role of fibrin glue in seroma reduction after modified radical mastectomy. International Surgery Journal. 2017;4:2103–9.

    Article  Google Scholar 

  27. Jain PK, Sowdi R, Anderson AD, MacFie J. Randomized clinical trial investigating the use of drains and fibrin sealant following surgery for breast cancer. Br J Surg. 2004;91:54–60.

    Article  CAS  PubMed  Google Scholar 

  28. Ko E, Han W, Cho J, et al. Fibrin glue reduces the duration of lymphatic drainage after lumpectomy and level II or III axillary lymph node dissection for breast cancer: a prospective randomized trial. J Korean Med Sci. 2009;24:92–6.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  29. Moore M, Burak WE Jr, Nelson E, et al. Fibrin sealant reduces the duration and amount of fluid drainage after axillary dissection: a randomized prospective clinical trial. J Am Coll Surg. 2001;192:591–9.

    Article  CAS  PubMed  Google Scholar 

  30. Miri Bonjar MR, Maghsoudi H, Samnia R, Saleh P, Parsafar F. Efficacy of fibrin glue on seroma formation after breast surgery. Int J Breast Cancer. 2012;2012:643132.

    Article  PubMed  PubMed Central  CAS  Google Scholar 

  31. Moore MM. Fibrin Sealant reduces drainage and allows for earlier drain removal after axillary dissection: a Randomized prospective trial. Am Surg. 1997;63:97–102.

    CAS  PubMed  Google Scholar 

  32. Mustonen PK, Härmä MA, Eskelinen MJ. The effect of fibrin sealant combined with fibrinolysis inhibitor on reducing the amount of lymphatic leakage after axillary evacuation in breast cancer. A prospective randomized clinical trial. Scand J Surg. 2004;93:209–12.

    Article  CAS  PubMed  Google Scholar 

  33. Ruggiero R, Procaccini E, Gili S, et al. New trends on fibrin glue in seroma after axillary lymphadenectomy for breast cancer. G Chir. 2009;30:306–10.

    CAS  PubMed  Google Scholar 

  34. Ruggiero R, Docimo G, Gubitosi A, et al. Axillary lymphadenectomy for breast cancer and fibrin glue. Ann Ital Chir. 2014;85:88–92.

    PubMed  Google Scholar 

  35. Tasinato R. Prevention of axillary seromas in patients who underwent limphadenectomy for breast cancer. Acta Chir Ital. 1993;49:479–84.

    Google Scholar 

  36. Udén P, Aspegren K, Balldin G, Garne JP, Larsson SA. Fibrin adhesive in radical mastectomy. Eur J Surg. 1993;159:263–5.

    PubMed  Google Scholar 

  37. Ulusoy AN, Polat C, Alvur M, Kandemir B, Bulut F. Effect of fibrin glue on lymphatic drainage and on drain removal time after modified radical mastectomy: a prospective randomized study. Breast J. 2003;9:393–6.

    Article  PubMed  Google Scholar 

  38. Vaxman F, Kolbe A, Stricher F, et al. Does fibrin glue improve drainage after axillary lymph node dissection? Prospective and randomized study in humans. Eur Surg Res. 1995;27:346–52.

    Article  CAS  PubMed  Google Scholar 

  39. Weber WP, Tausch C, Hayoz S, et al. Impact of a surgical sealing patch on lymphatic drainage after axillary dissection for breast cancer: the SAKK 23/13 multicenter randomized phase III trial. Ann Surg Oncol. 2018;25:2632–40.

    Article  PubMed  Google Scholar 

  40. Covarelli P, Barberini F, Cannavicci D, et al. Reduction of postoperative lymphorrhoea in patients undergoing radical lymphadenectomy for stage III melanoma: prospective study using collagen-fibrin patches. Minerva Chir. 2020;75:111–6.

    Article  PubMed  Google Scholar 

  41. Kim HC, Choi C, Kim WY. Effectiveness of fibrin sealant patch in reducing drain volume after pelvic lymph node dissection in women with gynecologic malignancy. Biomed Res Int. 2017;2017:3086857.

    PubMed  PubMed Central  Google Scholar 

  42. Eichler C, Fischer P, Sauerwald A, Dahdouh F, Warm M. Flap adhesion and effect on postoperative complication rates using Tissuglu® in mastectomy patients. Breast Cancer. 2016;23:486–90.

    Article  PubMed  Google Scholar 

  43. Llewellyn-Bennett R, Greenwood R, Benson JR, et al. Randomized clinical trial on the effect of fibrin sealant on latissimus dorsi donor-site seroma formation after breast reconstruction. Br J Surg. 2012;99:1381–8.

    Article  CAS  PubMed  Google Scholar 

  44. van Bastelaar J, Theunissen LLB, Snoeijs MGJ, Beets GL, Vissers YLJ. Flap fixation using tissue glue or sutures appears to reduce seroma aspiration after mastectomy for breast cancer. Clin Breast Cancer. 2017;17:316–21.

    Article  PubMed  Google Scholar 

Download references

Acknowledgment

This manuscript was edited by Wallace Academic Editing.

Funding

This work was supported by a research grant from Yuan’s General Hospital and Taipei Medical University (grant no. 108YGH-TMU-06). The sponsoring organization was not involved in the study design, data analysis, or interpretation of the results.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Ka-Wai Tam MD, PhD.

Ethics declarations

Disclosures

Ya-Ting Chang, Shen-Liang Shih, El-Wui Loh, and Ka-Wai Tam have no conflicts of interest or financial ties to disclose.

Additional information

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Electronic supplementary material

Below is the link to the electronic supplementary material.

Supplementary file1 (DOCX 43 kb)

Supplementary file2 (DOCX 24 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Chang, YT., Shih, SL., Loh, EW. et al. Effects of Fibrin Sealant on Seroma Reduction for Patients with Breast Cancer Undergoing Axillary Dissection: Meta-Analysis of Randomized Controlled Trials. Ann Surg Oncol 27, 5286–5295 (2020). https://doi.org/10.1245/s10434-020-08747-5

Download citation

  • Received:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1245/s10434-020-08747-5

Navigation