Reducing Seroma Formation and Its Sequelae After Mastectomy by Closure of the Dead Space: A Multi-center, Double-Blind Randomized Controlled Trial (SAM-Trial).
Journal
Annals of surgical oncology
ISSN: 1534-4681
Titre abrégé: Ann Surg Oncol
Pays: United States
ID NLM: 9420840
Informations de publication
Date de publication:
May 2021
May 2021
Historique:
received:
02
06
2020
accepted:
17
09
2020
pubmed:
21
10
2020
medline:
15
5
2021
entrez:
20
10
2020
Statut:
ppublish
Résumé
Seroma is a common complication after mastectomy, with an incidence of 3% to 85%. Seroma is associated with pain, delayed wound healing, and additional outpatient clinic visits, leading potentially to repeated seroma aspiration or even surgical interventions. This study aimed to assess the effect of flap fixation using sutures or tissue glue in preventing seroma formation and its sequelae. Between June 2014 and July 2018, 339 patients with an indication for mastectomy or modified radical mastectomy were enrolled in this randomized controlled trial in the Netherlands. Patients were randomly allocated to one of the three following arms: conventional wound closure (CON, n = 115), flap fixation using sutures (FFS, n = 111) or flap fixation using tissue glue (FFG, n = 113). The primary outcome was the need for seroma aspiration. The secondary outcomes were additional outpatient department visits, surgical-site infection, shoulder function and mobility, cosmesis, skin-dimpling, and postoperative pain scores. Flap fixation after mastectomy leads to fewer seroma aspirations than conventional wound closure (CON 17.5% vs FFS 7.3% vs FFG 10.8%; p = 0.057), with a significant difference between flap fixation with sutures and conventional wound closure (odds ratio [OR], 0.37; 95% confidence interval [CI], 0.16-0.89; p = 0.025). Flap fixation has no significant negative effect on surgical-site infections, shoulder function and mobility, cosmesis, skin-dimpling, or postoperative pain. Flap fixation using sutures leads to a significant reduction in aspirations of post-mastectomy seromas. The authors strongly advise surgeons to use sutures for flap fixation in patients undergoing mastectomy. (ClinicalTrials.gov no. NCT03305757). The trial was registered after enrollment of the first participant. However, no specific explanation exists for this except that through the years more importance has been given to central trial registration. Our research team can ensure that after enrollment of the first participant, no changes were made to the trial, analysis plan, and/or study design.
Sections du résumé
BACKGROUND
BACKGROUND
Seroma is a common complication after mastectomy, with an incidence of 3% to 85%. Seroma is associated with pain, delayed wound healing, and additional outpatient clinic visits, leading potentially to repeated seroma aspiration or even surgical interventions. This study aimed to assess the effect of flap fixation using sutures or tissue glue in preventing seroma formation and its sequelae.
METHODS
METHODS
Between June 2014 and July 2018, 339 patients with an indication for mastectomy or modified radical mastectomy were enrolled in this randomized controlled trial in the Netherlands. Patients were randomly allocated to one of the three following arms: conventional wound closure (CON, n = 115), flap fixation using sutures (FFS, n = 111) or flap fixation using tissue glue (FFG, n = 113). The primary outcome was the need for seroma aspiration. The secondary outcomes were additional outpatient department visits, surgical-site infection, shoulder function and mobility, cosmesis, skin-dimpling, and postoperative pain scores.
RESULTS
RESULTS
Flap fixation after mastectomy leads to fewer seroma aspirations than conventional wound closure (CON 17.5% vs FFS 7.3% vs FFG 10.8%; p = 0.057), with a significant difference between flap fixation with sutures and conventional wound closure (odds ratio [OR], 0.37; 95% confidence interval [CI], 0.16-0.89; p = 0.025). Flap fixation has no significant negative effect on surgical-site infections, shoulder function and mobility, cosmesis, skin-dimpling, or postoperative pain.
CONCLUSION
CONCLUSIONS
Flap fixation using sutures leads to a significant reduction in aspirations of post-mastectomy seromas. The authors strongly advise surgeons to use sutures for flap fixation in patients undergoing mastectomy. (ClinicalTrials.gov no. NCT03305757).
PREREGISTRATION
BACKGROUND
The trial was registered after enrollment of the first participant. However, no specific explanation exists for this except that through the years more importance has been given to central trial registration. Our research team can ensure that after enrollment of the first participant, no changes were made to the trial, analysis plan, and/or study design.
Identifiants
pubmed: 33078318
doi: 10.1245/s10434-020-09225-8
pii: 10.1245/s10434-020-09225-8
doi:
Banques de données
ClinicalTrials.gov
['NCT03305757']
Types de publication
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
2599-2608Références
Kumar S, Lal B, Misra MC. Post-mastectomy seroma: a new look into the aetiology of an old problem. J R Coll Surg Edinb. 1995;40:292–4.
pubmed: 8523301
Woodworth PA, McBoyle MF, Helmer SD, Beamer RL. Seroma formation after breast cancer surgery; incidence and predicting factors. Am Surg. 2000;66: 444–50.
pubmed: 10824744
Carless PA, Henry DA. Systematic review and meta-analysis of the use of fibrin sealant to prevent seroma formation after breast cancer surgery. Br J Surg. 2006;93:810–9.
doi: 10.1002/bjs.5432
Agrawal A, Ayantunde AA, Cheung KL. Concepts of seroma formation and prevention in breast cancer surgery. ANZ J Surg. 2006;76:1088–95.
doi: 10.1111/j.1445-2197.2006.03949.x
Van Bastelaar J, Beckers A, Snoeijs M, Beets G, Vissers Y. Flap fixation reduces seroma in patients undergoing mastectomy: a significant implication for clinical practice. World J Surg Oncol. 2016;14:66.
doi: 10.1186/s12957-016-0830-8
Srivastava V, Basu S, Shukla VK. Seroma formation after breast cancer surgery: what we have learned in the last two decades. J Breast Cancer. 2012;15:373–80.
doi: 10.4048/jbc.2012.15.4.373
Currie A, Chong K, Davies GL, Cummins RS. Ultrasonic dissection versus electrocautery in mastectomy for breast cancer: a meta-analysis. Eur J Surg Oncol. 2012;38:897–901.
doi: 10.1016/j.ejso.2012.05.006
Khan S, Chawla T, Murtaza G. Harmonic scalpel versus electrocautery dissection in modified radical mastectomy: a randomized controlled trial. Ann Surg Oncol. 2014;21:808–14.
doi: 10.1245/s10434-013-3369-8
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.
doi: 10.3346/jkms.2009.24.1.92
Almond LM, Khodaverdi L, Kumar B, Coveney EC. Flap anchoring following primary breast cancer surgery facilitates early hospital discharge and reduces costs. Breast Care Basel. 2010;5:97–101.
doi: 10.1159/000301586
Sakkary MA. The value of mastectomy flap fixation in reducing fluid drainage and seroma formation in breast cancer patients. World J Surg Oncol. 2012:10:8.
doi: 10.1186/1477-7819-10-8
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;21:802–7.
doi: 10.1245/s10434-013-3359-x
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.
doi: 10.1016/j.ijsu.2014.10.005
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.
doi: 10.1007/s12282-015-0591-1
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.
doi: 10.1016/j.clbc.2017.04.004
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;17:316–21.
doi: 10.1016/j.clbc.2017.01.005
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;167:409–16.
doi: 10.1007/s10549-017-4540-x
Granzier RWY, van Bastelaar J, van Kuijk SMJ et al. Reducing seroma formation and its sequelae after mastectomy by closure of the dead space: the interim analysis of a multi-center, double-blind randomized controlled trial (SAM trial). Breast. 2019;46:81–6.
doi: 10.1016/j.breast.2019.05.002
Hudak P, Amadio PC, Bombardier C, the Upper Extremity Collaborative Group. Development of an upper extremity outcome measure: The DASH (Disabilities of the Arm, Shoulder, and Hand). Am J Industrial Med. 1996;29:602–8.
doi: 10.1002/(SICI)1097-0274(199606)29:6<602::AID-AJIM4>3.0.CO;2-L
Coveney EC, O’Dwyer PJ, Geraghty JG, O’Higgins NJ. Effect of closing dead space on seroma formation after mastectomy: a prospective randomized controlled trial. Eur J Surg Oncol. 1993;19:143–6.
pubmed: 8491318
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.
doi: 10.1186/1477-7819-2-44
Gonzalez EA, Saltzstein EC, Riedner CS, Nelson BK. Seroma formation following breast cancer surgery. Breast J. 2003;9:385–8.
doi: 10.1046/j.1524-4741.2003.09504.x