Zackariah Clement^*, Peter Shin, Clive Hoffmann, Michael Eaton, William McLeay

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Breast and Endocrine Surgery Unit, Flinders Medical Centre, Adelaide, Australia.
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Abstract: Background and Purpose: Seroma formation is a common complication following a mastectomy and axillary surgery. Decreasing the dead space is believed to decrease seroma formation. The aim of this study is to compare the incidence of seroma formation with the use of Glubran-2 versus normal saline during the wound closure in participants undergoing mastectomy with or without axillary dissection. Methods: This multicentre, prospective, double-blinded, randomised controlled trial, enrolled women 18 years of age or older with breast cancer, who were underwent total or partial mastectomy, with or without axillary dissection. Participants were randomised to Glubran-2 or Saline arm. The primary outcome was the volume and duration of wound seroma. Secondary outcome was post-operative wound infection. Results: A total of 76 women were randomised and there was no loss to follow-up or mortality. The total seroma volume was higher in the Glubran-2 arm. The duration of seroma was higher in the mastectomy and axillary dissection group in the Glubran-2 arm (P = 0.69). Elderly and participants with higher BMI had a higher volume of seroma. Post-operative infection rate was higher in the Glubran-2 arm (13.2% vs. 5.6%; P = 0.26). There was no statistically significant difference between the groups. Conclusion: Our study did not show any benefit with the use of Glubran-2 in mastectomy and axillary surgery in reducing the risk of seroma formation. In elderly and obese participants the use of Glubran-2 showed an increase in seroma formation and post-operative wound infection.

Keywords: Breast Cancer, Mastectomy, Axillary Dissection, Seroma, Glubran, Cyanoacrylate Glue

Cite this paper: Clement, Z. , Shin, P. , Hoffmann, C. , Eaton, M. and McLeay, W. (2017) A Double-Blinded Prospective Randomised Controlled Trial to Assess the Efficacy of Glubran-2 in Reducing Seroma Formation after a Mastectomy with or without Axillary Dissection. Advances in Breast Cancer Research, 6, 117-128. doi: 10.4236/abcr.2017.64011.

References

[1]   Kumar, S., Lal, B. and Misra, M.C. (1995) Post-Mastectomy Seroma: A New Look into the Aetiology of an Age-Old Problem. Journal of the Royal College of Surgeons of Edinburgh, 40, 27-29.

[2]   Sampathraju, S. and Rodrigues, G. (2010) Seroma Formation after Mastectomy: Pathogenesis and Prevention. Indian Journal of Surgical Oncology, 1, 328-333.
https://doi.org/10.1007/s13193-011-0067-5

[3]   Srivastava, V., Basu, S. and Shukla, V.K. (2012) Seroma Formation after Breast Cancer Surgery: What We Have Learned in the Last Two Decades. Journal of Breast Cancer, 15, 373-380.
https://doi.org/10.4048/jbc.2012.15.4.373

[4]   Park, S.Y., Kim, E.Y., Park, H.K., et al. (2014) Computed Tomographic Findings of Postoperative Seroma in Breast Cancer Patients. Journal of Breast Disease, 2, 64-68.
https://doi.org/10.14449/jbd.2014.2.64

[5]   Faisal, M., Abu-Elela, S.T., Mostafa, W., et al. (2016) Efficacy of Axillary Clearance on Seroma Formation after Modified Radical Mastectomy. World Journal of Surgical Oncology, 14, 1-5.
https://doi.org/10.1186/s12957-016-0801-0

[6]   Turner, E.J., Benson, J.R. and Winters, Z.E. (2014) Techniques in the Prevention and Management of Seromas after Breast Surgery. Future Oncology, 10, 1049-1063.
https://doi.org/10.2217/fon.13.257

[7]   Concersano, A., Mazouni, C., Thomin, A., et al. (2017) Use of Low-Thrombin Fibrin Sealant Glue after Axillary ly Phadenectomy for Breast Cancer to Reduce Hospital Length and Seroma. Clinical Breast Cancer, 17, 293-297.
https://doi.org/10.1016/j.clbc.2016.12.013

[8]   Kuroi, K., Shimozuma, K., Taguchi, T., et al. (2006) Evidence-Based Risk Factors for Seroma Formation in Breast Surgery. Japanese Journal of Clinical Oncology, 36, 197-206.
https://doi.org/10.1093/jjco/hyl019

[9]   Coveney, C.Y., O’Dwyer, P.J., Geraghty, J.G., et al. (1993) Effect of Closing Dead Space on Seroma Formation after Mastectomy—A Prospective Randomised Clinical Trial. European Journal of Surgical Oncology, 19, 143-146.

[10]   Kuroi, K., Shimozuma, K., Taguchi, T., et al. (2006) Effect of Mechanical Closure of Dead Space on Seroma Formation after Breast Surgery. Breast Cancer, 13, 260-265.
https://doi.org/10.2325/jbcs.13.260

[11]   Janis, J.E., Khansa, L. and Khansa, I. (2016) Strategies for Postoperative Seroma Prevention: A Systematic Review. Plastic and Reconstructive Surgery, 138, 240-252.
https://doi.org/10.1097/PRS.0000000000002245

[12]   Bonjar, M.R.M., Maghsoudi, H., Samnia, R., et al. (2012) Efficacy of Fibrin Glue on Seroma Formation after Breast Surgery. International Journal of Breast Cancer, 2012, Article ID: 643132.

[13]   Jain, P.K., Sowdi, R., Anderson, A.D.G., et al. (2004) Randomized Clinical Trial Investigating the Use of Drains and Fibrin Sealant Following Surgery for Breast Cancer. British Journal of Surgery, 91, 54-60.
https://doi.org/10.1002/bjs.4435

[14]   Qvamme, G., Axelsson, C.K., Lanng, C., et al. (2015) Randomised Clinical Trial of Prevention of Seroma Formation after Mastectomy by Local Methylprednisolone Injection. British Journal of Surgery, 102, 1195-1203.
https://doi.org/10.1002/bjs.9874

[15]   Rice, D.C., Morris, S.M., Sarr, M.G., et al. (2000) Intraoperative Tropical Tetracycline Sclerotherapy Following Mastectomy: A Prospective Randomised Trial. Journal of Surgical Oncology, 73, 224-227.
https://doi.org/10.1002/(SICI)1096-9098(200004)73:4<224::AID-JSO7>3.0.CO;2-0

[16]   Mazouni, C., Mesnard, C., Clouter, A., et al. (2015) Quilting Sutures Reduces Seroma in Mastectomy. Clinical Breast Cancer, 15, 289-293.

[17]   Van Bastellar, J., Beckers, A., Snoejis, M., et al. (2016) Flap Fixation Reduces Seroma in Patients Undergoing Mastectomy: A Significant Implication for Clinical Practice. World Journal of Surgical Oncology, 14, 66.
https://doi.org/10.1186/s12957-016-0830-8

[18]   Ouldamer, L., Bonastre, J., Brunet-Houdard, S., et al. (2016) Dead Space Closure with Quilting Suture versus Conventional Closure with Drainage for the Prevention of Seroma after Mastectomy for Breast Cancer (QUISERMAS): Protocol for Multicentre Randomised Controlled Trial. BMJ Open, 6.

[19]   Kull, S., Eng, M., Martinelli, I., et al. (2009) Glubran 2 Surgical Glue: In Vitro Evaluation of Adhesive and Mechanical Properties. Journal of Surgical Research, 157, e15-e21.

[20]   Haghpanah, S., Vafar, A., Golzadeh, M.H., et al. (2011) Use of Glubran 2 and Glubran Tissue Skin Adhesive in Patients with Hereditary Bleeding Disorders Undergoing Circumcision and Dental Extraction. Annals of Hematology, 90, 463-468.
https://doi.org/10.1007/s00277-010-1086-y

[21]   Paajanen, H., Kossi, J., Silvasti, S., et al. (2011) Randomised Clinical Trial of Tissue Glue versus Absorbable Sutures for Mesh Fixation in Local Anaesthetic Lichtenstein Hernia Repair. British Journal of Surgery, 98, 1245-1251.
https://doi.org/10.1002/bjs.7598

[22]   Lasheen, A.E., Tolba, A.M., Mohamed, H., et al. (2013) Laparoscopic Inguinal Hernia Repair with Closure of Hernia Defect and Central Mesh Fixation using Glubran 2. Surgical Science, 4, 554-557.
https://doi.org/10.4236/ss.2013.412107

[23]   Garcia-Vallejo, L., Couto-Gonzalez, I., Concheiro-Coello, P., et al. (2014) Cyanoacrylate Surgical Glue for Mesh Fixation in Laparoscopic Total Extraperitoneal Hernia Repair. Surgical Laparoscopy Endoscopy & Percutaneous Techniques, 24, 240-243.
https://doi.org/10.1097/SLE.0b013e3182a2f008

[24]   Bifulco, G., Giampaolino, P., Morra, I., et al. (2014) Synthetic Cyanoacrylic Glue in the Prevention of Post-Operative Lymphocele after Pelvic Lymphadenectomy in Patients with Uterine Malignancies: A Prospective, Single Blinded, Preliminary Study. Gynecologic Oncology, 134, 556-560.

[25]   AIHW (2017) Cancer in Australia 2017 [PDF on Internet]. Cancer Series No. 101, Cat. No. CAN 100, Australian Government, Canberra.
http://www.aihw.gov.au/WorkArea/DownloadAsset.aspx?id=60129559144

[26]   Roder, D., Zorbas, H., Kollias, J., et al. (2013) Factors Predictive of Treatment by Australian Breast Surgeons of Invasive Female Breast Cancer by Mastectomy Rather than Breast Conserving Surgery. Asian Pacific Journal of Cancer Prevention, 14, 539-545.
https://doi.org/10.7314/APJCP.2013.14.1.539