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)

Granzier, R.; Bastelaar, James van; Kuijk, Sander M. J. van; Hintzen, Kim F.H.; Heymans, Cathelijne; Theunissen, Lotte L.B.; Haaren, Elisabeth R.M. van; Janssen, Alfred; Beets, Geerard L.; Vissers, Yvonne L. J.

doi:10.1016/j.breast.2019.05.002

Cited by 31 publications

(54 citation statements)

References 27 publications

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“…Although the scientific body of evidence favoring flap fixation after mastectomy is convincing, a systematic review of flap fixation technique [13] suggests that mechanical flap fixation seems to reduce seroma formation and seroma aspiration after mastectomy. In addition, randomized studies [14][15][16] reported that mastectomy followed by flap fixation with either sutures or adhesive tissue glue reduces the number of seromas requiring needle aspirations as compared to cases of simple wound closure. The use of adhesive tissue glue and sutures seems to be equally effective [14].…”

Section: Discussionmentioning

confidence: 99%

Effects of Different Applications on Postoperative Seroma Formation and Wound Healing Following Mastectomy and Axillary Dissection in Rats

et al. 2021

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The most frequent postoperative complication after breast surgery is seroma formation. Seroma occurs due to lymphatic and vascular fluid leakage into the dead space created by surgical dissection. The objective of the research was to evaluate the effects of local fibrin glue, tetracycline, talc applications, and flap fixation technique on reducing seroma formation after mastectomy and axillary dissection. In addition, we aimed to determine the level of efficacy for these applications, as well as to identify the most appropriate method to be used in operations with high risk of seroma formation. Materials and Methods. This experimental study was conducted using a total of 60 female Wistar albino rats. They were allocated into six groups and each comprised ten rats. Unilateral mastectomy and axillary dissection were performed on all the rats. Local applications of fibrin glue, tetracycline, talc, and alcoholic iodine were performed in four separate groups. Flap fixation technique was applied in one group and those rats that did not receive any intervention constituted the control group. On the 10th postoperative day, seroma was aspirated under anesthesia, and the amount of seroma fluid was recorded. Seroma fluid was analyzed for interleukin 1-β, vascular endothelial growth factor, and C-reactive protein levels. Tissue samples were obtained from the skin overlaying the dissection area, the axilla, and the thoracic wall. Wound healing was evaluated with histopathological examination. Results. Seroma volume was lower and the wound healing scores were the highest in the flap fixation group and the tetracycline group as compared to the control group. However, the alcoholic iodine group and the talc group had a greater amount of seroma (p < 0.05). There was no difference between the fibrin glue group and the control group. Conclusions. In our mastectomy model, local application of alcoholic iodine and talc substances caused more wound site problems and postoperative seroma formation. While fibrin glue did not cause wound site problems, it did increase seroma formation. These three substances were determined to be inefficacious in postoperative seroma formation. Local tetracycline application and flap fixation technique were found to reduce postoperative seroma and benefit wound healing.

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Section: Discussionmentioning

confidence: 99%

Effects of Different Applications on Postoperative Seroma Formation and Wound Healing Following Mastectomy and Axillary Dissection in Rats

et al. 2021

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“…In a retrospective study by Eichler et al [ 25 ], seroma formation was nearly significantly higher in the intervention (TissuGlu) group. However, Granzier et al [ 18 ] recently published an interim analysis of a prospective randomized controlled trial (seroma reduction after mastectomy-trial, SAM TRIAL) which revealed that mastectomy followed by flap fixation with either sutures or adhesive tissue glue reduces the number of seroma aspirations. Therefore, the effectiveness of tissue glues in preventing seroma formation is still controversial, and more studies are required to evaluate its effect in relation to flap fixation.…”

Section: Discussionmentioning

confidence: 99%

“…The results showed no differences in dimpling of the skin between the 2 groups on follow-up for 3 months. Even if there was skin dimpling, it seemed to decrease over time, when following up for 1 year [ 18 ]. Overall, the fascia suture technique did not worsen common complications.…”

Section: Discussionmentioning

confidence: 99%

“…Among these techniques, mechanical flap fixation effectively reduces seroma formation and seroma aspiration in patients undergoing mastectomy, based on a systematic review [ 11 12 ]. However, in previous studies, nearly all authors fixed the flap by suturing the skin and subcutaneous tissue to the underlying muscles (pectoralis major muscle or pectoral fascia [ 13 ], latissimus dorsi muscle, or anterior serratus muscle) with several parallel rows of evenly spaced sutures at about 3–5 cm [ 14 15 16 17 18 19 20 ]. This continuous multirow fixation of the flap to the chest wall every 3 cm prolongs the duration of surgery and increases the patient's trauma.…”

Section: Introductionmentioning

confidence: 99%

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Fascia Suture Technique Is a Simple Approach to Reduce Postmastectomy Seroma Formation

et al. 2020

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Purpose Seroma formation is a common complication in breast cancer patients undergoing mastectomy, and it negatively affects patient recovery after surgery. The present study aimed to evaluate a simple method using fascia suture technique to fix the flap and reduce the incidence of seroma. Methods A single-center, prospective, randomized controlled trial was carried out among 160 patients who had undergone mastectomy from May 2018 to September 2019. All patients were randomly divided into the fascia suture group (n = 80) or control group (n = 80) and were followed up for at least 3 months for the assessment of immediate and late complications after surgery. Results No significant differences were observed between the 2 groups with regard to the basic characteristics. Duration of surgery in the fascia suture group was longer by about 6 minutes compared with that in the control group (114.93 ± 13.67 minutes vs. 108.81 ± 15.20 minutes, p = 0.008). The fascia suture group had a shorter duration of drain placement (10.99 ± 3.26 days vs. 13.85 ± 5.37 days, p < 0.001), a smaller volume of the total drainage (460.95 ± 242.92 mL vs. 574.83 ± 285.23 mL, p = 0.007), and the first 3-day drainage (224.96 ± 101.01 mL vs. 272.3 ± 115.47 mL, p = 0.006), compared with the control group. The incidence of seroma formation (G2 or G3) was significantly lower in the fascia suture group compared with the control group (28.8% vs. 12.5%, p = 0.033). Besides, there was no statistical difference between the 2 groups in the assessment of other complications, including postoperative pain, hematoma, surgical site infections, flap necrosis, and skin dimpling (all p > 0.050). Conclusion The fascia suture technique is a simple and effective method for reducing seroma formation and should be used to prevent seroma formation after mastectomy. Trial Registration Chinese Clinical Trials Registry Identifier: ChiCTR1800015913

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“…Flap fixation with tissue glue appears to yield similar results when compared to flap fixation using sutures [ 10 ]. This conclusion is supported by an interim analysis of a trial by Granzier et al (2019), showing that flap fixation with either sutures or adhesive tissue glue reduces the number of needle aspirations compared to patients undergoing simple wound closure [ 11 ]. Other studies on flap fixation also show promising results in reducing the incidence of seroma and seroma aspirations after breast cancer surgery [ 12 – 18 ].…”

Section: Introductionmentioning

confidence: 95%

A single-center, randomized, non-inferiority study evaluating seroma formation after mastectomy combined with flap fixation with or without suction drainage: protocol for the Seroma reduction and drAin fRee mAstectomy (SARA) trial

et al. 2020

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Background: Seroma formation is a common complication after breast cancer surgery and can lead to delayed wound healing, infection, patient discomfort and repeated visits to the outpatient clinic. Mastectomy combined with flap fixation is becoming standard practice and is currently combined with closed-suction drainage. There is evidence showing that closed-suction drainage may be insufficient in preventing seroma formation. There is reasonable doubt whether there is still place for closed-suction drainage after mastectomy when flap fixation is performed. We hypothesize that mastectomy combined with flap fixation and closed suction drainage does not cause a significant lower incidence of seroma aspirations, when compared to mastectomy and flap fixation alone. Furthermore, we expect that patients without drainage will experience significantly less discomfort and comparable rates of surgical site infections.

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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)

Cited by 31 publications

References 27 publications

Effects of Different Applications on Postoperative Seroma Formation and Wound Healing Following Mastectomy and Axillary Dissection in Rats

Effects of Different Applications on Postoperative Seroma Formation and Wound Healing Following Mastectomy and Axillary Dissection in Rats

Fascia Suture Technique Is a Simple Approach to Reduce Postmastectomy Seroma Formation

A single-center, randomized, non-inferiority study evaluating seroma formation after mastectomy combined with flap fixation with or without suction drainage: protocol for the Seroma reduction and drAin fRee mAstectomy (SARA) trial

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