Dead space closure with quilting suture versus conventional closure with drainage for the prevention of seroma after mastectomy for breast cancer (QUISERMAS): protocol for a multicentre randomised controlled trial

Ouldamer, Lobna; Bonastre, Julia; Brunet-Houdard, Solène; Body, G.; Giraudeau, Bruno; Caille, Agnès

doi:10.1136/bmjopen-2015-009903

Cited by 34 publications

(32 citation statements)

References 32 publications

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“…Pharmaceutical agents such as fibrin glue, light activated fibrin sealant, tetracycline, somatostatin analogues, corticosteroids, and sclerosing agents have been trialled but failed to demonstrate any convincing benefit in reducing seroma formation [2] [6]- [15]. Quilting sutures have been shown to have some benefit in reducing seroma formation, volume and length of drainage time but can cause significant pain and discomfort [16] [17] [18]. Despite all these techniques and agents there is no efficient single solution to tackle this common complication.…”

Section: Resultsmentioning

confidence: 99%

“…Glubran-2 polymerises rapidly on contact and firmly adheres to the tissues. It is reported to have good haemostatic and adhesive properties [18]- [24]. This adhesive property can obliterate the dead space after mastectomy and axillary dissection.…”

Section: Introductionmentioning

confidence: 99%

“…Some studies have reported that decreasing the dead space after surgery reduces seroma formation [6] [9] [10]. Several techniques have been trialled including drains, quilting sutures, fibrin glue, tetracycline sclerosing agents, methylprednisolone, and somatostatin analogues to reduce the dead space, volume and duration of seroma [2] [6] [7] [9]- [18]. Although some authors have reported that reducing the dead space minimises volume and duration of seroma, to date there is no general consensus in a single technique to reduce the risk of seroma formation [9] [10] [11].…”

Section: Introductionmentioning

confidence: 99%

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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

Clement¹,

Shin²,

Hoffmann³

et al. 2017

ABCR

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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.How to cite this paper:

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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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

Clement¹,

Shin²,

Hoffmann³

et al. 2017

ABCR

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show abstract

“…Various attempts have been proposed in order to reduce seroma formation, such as external compression dressing [37], drainage placement [38][39][40][41], usage of fibrin glue [42,43], flap fixation and obliteration of the dead space [44], unfortunately with inconsistent results.…”

Section: Discussionmentioning

confidence: 99%

Advanced hemostasis in axillary lymph node dissection for locally advanced breast cancer: new technology devices compared in the prevention of seroma formation

et al. 2019

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Background: Breast cancer is the most frequent neoplasm in women. Axillary lymph nodes dissection represents the treatment of choice in locally advanced breast cancer for prognostic and curative purposes. Seroma formation, an abnormal collection of fluid in the dead space of the axilla, is described in Literature with a wide range of incidence (3-85%). It is a source of significant morbidity and discomfort. The aim of the study is to compare the different haemostasis devices used in breast surgery, investigating the eventual superiority of an instrument among the others in terms of intraoperative and postoperative outcome, especially of seroma formation. Methods: Clinical cases of female patients undergone axillary lymph nodes dissection for local advanced breast cancer between January 2013 and July 2017 at the Surgery Unit of University of Campania "Luigi Vanvitelli" were retrospectively reviewed. Patients were divided into four groups, according to device utilized during surgery: Electrocautery, Harmonic Scalpel, LigaSure and Thunderbeat. All patients underwent II level axillary lymph nodes dissection associated to radical mastectomy or quadrantectomy. Results: One hundred consecutives patients were enrolled in the study. Intra-operative blood loss resulted statistically significant different (P < 0,01) between the Electrocautery group (94,7 ml) and the Thunderbeat group (57,2 ml), while the Harmonic Scalpel group and the Ligasure group, despite presented a lower amount of blood loss, did not differ significantly. Drainage volume resulted significantly lower (P = 0,002) in the comparison between the Electrocautery group and the Thunderbeat group; the Ligasure group and Harmonic Scapel group showed no difference between them and Electrocautery group. About the seroma formation, the Electrocautery group resulted affected by the highest seroma formation rate (64%). Seroma incidence in Harmonic Scalpel group was 24%, in Ligasure group was 44%, while Thunderbeat group showed the lowest presentation of seroma with 16%. Conclusions: In patients affected by breast cancer requiring axillary lymphnodes dissection, the use of advanced hemostasis devices is highly desirable. Among the non-traditional tools, Thunderbeat resulted to be superior in terms of reduction of intra-operative blood loss and post-operative drainage output, moreover associated to a substantial reduction of postoperative seroma incidence.

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“…Experienced breast surgeons using a standardized technique performed mastectomies (16). The skin incision included the tumor biopsy site, any invaded or edematous skin and the nipple-areola complex (17). The present study addressed the type of wound closure in mastectomy.…”

Section: Methodsmentioning

confidence: 99%

Retrospective observational cohort study on cosmetic outcome of using Ti‑Ni memory alloy wire for intradermal suture following mastectomy in patients with breast cancer

Qin

Sun

et al. 2017

Oncol Lett

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Abstract. The method of suturing for incisions is crucial for the comprehensive treatment of clinical patients with breast cancer. Suturing is considered a major part of post-surgical recovery and may serve as a marker for evaluation of surgical outcome. The present study aimed to establish an effective means of suturing for patients who received modified radical surgery that helps to improve the cosmetic outcome of the incision. Enrolled patients were divided into an active and a control group. Ti-Ni memory alloy wire for intradermal suture in the active group and silk for interruption suture in the control group were applied to assess the different prognosis-associated factors. The Vancouver Scar Scale (VSS) was used to evaluate the wound size and the recovery time of the scars. The association between diabetes and the number of days of wound healing was also analyzed. The results indicated that the mean VSS score of the active group was decreased compared with that of the control group (P<0.001). The VSS scores of four main features (vascularity, pigmentation, pliability and height) between the two groups also statistically differed (P<0.001). Furthermore, the mean number of days of wound healing was significantly decreased for the active group compared with that for the control group (P=0.0026) in the patients with diabetes. In addition, the usage of Ti-Ni memory alloy wire was able to decrease the mean number of wound healing days between patients with diabetes and their non-diabetic counterparts (P=0.7009). The present study indicated that intradermal suture offers improved cosmetic outcome for patients undergoing mastectomy with or without axillary surgery. This technique may be useful for preventing scar overgrowth and for facilitating the recovery process in patients with diabetes. IntroductionIn 1882, Halsted pioneered the radical resection of the breast. Breast surgery methods have changed since and clinicians commonly perform breast-conserving surgery. However, the optimal approach for radical resection remains controversial (1). Along with social progress and improvements in the quality of life, patients with cancer, particularly patients with breast cancer have increasing requirements for the function and cosmetic outcome following surgery (2,3). A previous study identified that 61% of patients reported that the opinions of their partners of the scars were important to them (4). The way an incision is closed and managed post-operatively affects cosmetic outcome (5). Historically, in breast cancer surgery, simultaneously ensuring treatment effect, shrinking excision scope and attending to the cosmetic effect has been important (6). To improve the aesthetic results for female patients undergoing breast cancer surgery, surgical techniques have been developed to render scars less noticeable (7,8).In China, the majority of patients with breast cancer are treated with modified radical surgery using discontinuous silk suture, which leaves a very noticeable scar (9). A study on cosmetic surgery identified ...

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Dead space closure with quilting suture versus conventional closure with drainage for the prevention of seroma after mastectomy for breast cancer (QUISERMAS): protocol for a multicentre randomised controlled trial

Cited by 34 publications

References 32 publications

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

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

Advanced hemostasis in axillary lymph node dissection for locally advanced breast cancer: new technology devices compared in the prevention of seroma formation

Retrospective observational cohort study on cosmetic outcome of using Ti‑Ni memory alloy wire for intradermal suture following mastectomy in patients with breast cancer

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