Routine closed-suction drainage reduces seromas following totally extraperitoneal (TEP) inguinal hernia repair: A meta-analysis.

BACKGROUND: The value of prophylactic closed-suction drainage in totally extraperitoneal inguinal hernia repair (TEP) is still a matter of controversy. We conducted a meta-analysis of studies examining postoperative seroma rates in patients with or without routine placement of closed-suction drainage tubes. METHODS: A systematic literature search was conducted for trials comparing the outcome of TEP with or without routine drainage placement. Data regarding postoperative outcomes were extracted and compared by meta-analysis. The odds ratio and standardized mean differences with 95% confidence intervals were calculated. RESULTS: Four studies were identified, involving a total of 1626 cases (Drain: n = 1251, no Drain: n = 375). There was a statistically significant difference noted between the 2 groups regarding postoperative seroma formation favoring the Drain group (odds ratio = 0.12; 95% confidence intervals [0.05, 0.29]; P < .001; 4 studies; I2 = 72%). For the remaining secondary endpoints postoperative urinary retention, recurrence, mesh infection and in-hospital length of stay no statistically significant difference was noted between the 2 study groups. CONCLUSION: Current evidence suggests that patients who underwent TEP with routine closed-suction drain placement developed significantly fewer seromas without any additional morbidity or prolongation of in-hospital stay.

The effect of internal orifice narrowing in laparoscopic inguinoscrotal hernia repair to prevent seroma formation: a prospective double-blind randomized controlled trial.

OBJECTIVES: Seroma represents the most prevalent postoperative complication following laparoscopic inguinal hernia repair, particularly in the case of large inguinoscrotal hernias. This randomized controlled trial was undertaken with the objective of assessing the effects of internal orifice narrowing achieved by suturing the divided distal hernia sac in laparoscopic repair of indirect inguinoscrotal hernias. METHODS: A total of 58 patients aged 18 years or older, were randomized into two groups: Group I, which underwent internal orifice narrowing, and Group II, which served as the control without narrowing. The study's primary endpoint was the incidence and volume of seroma in the inguinal region on postoperative days 1 and 7, as well as at 1, 3, and 6 months following the procedure. Secondary outcomes encompassed metrics like total operative time, acute and chronic pain levels, duration of hospital stay, recurrence rates, and the occurrence of any additional complications. RESULTS: In comparison to the control group, the experimental group exhibited a significantly lower incidence of seroma formation at 7 days (P = 0.001). Furthermore, the ultrasonic assessment indicated a reduced seroma volume in the operative group on postoperative day 7 (8.84 ± 17.71 vs. 52.39 ± 70.78 mL; P < 0.001). Acute pain levels and hospital stay were similar between the two groups (1.22 ± 0.76 vs. 1.04 ± 0.53, P = 0.073; 1.22 ± 0.07 vs. 1.19 ± 0.08, P = 0.627, respectively). Notably, neither chronic pain nor early recurrence, nor any other postoperative complications were observed in either group throughout the follow-up period, which extended for at least 6 months (range: 6-18 months). CONCLUSION: In the context of laparoscopic inguinoscrotal hernia repair, the incidence and volume of seroma can be significantly reduced through the implementation of internal orifice narrowing achieved by suturing the divided distal hernia sac. And, this reduction in seroma formation was not associated elevation in postoperative pain levels or recurrence rates.

Seroma control in axillary lymphadenectomy with Glubran 2® without drain. Multicenter, prospective, randomized, clinical trial. GALA-ND study (Glubran, Axillary Lymphadenectomy, Ambulatory, No Drain).

BACKGROUND: Seroma after breast cancer surgery is a frequent entity; therefore, different products have been described in literature with the aim to reduce it. The most studied ones have been the sealants products, being tested with aspirative drains. Symptomatic seroma represents the 19% after axillary lymphadenectomy without drains. The aim of this study is to analyze the effect of a sealant in the seroma control after axillary lymphadenectomy without drains and identify the risk factors related to symptomatic seroma. METHODS: This is a prospective, multicenter, international, and randomized clinical trial. Patients undergoing conservative surgery and axillary lymphadenectomy for breast cancer will be randomized to control group (lymphadenectomy without sealant) or interventional group (lymphadenectomy with sealant Glubran 2®). In any of the study groups, drains are placed. Patients who received neoadjuvant treatment are included. Measurements of the study outcomes will take place at baseline; at 7, 14, and 30 days post-surgery; and at 6-12 months. The primary outcome is symptomatic seroma. Secondary outcomes are seroma volume, morbidity, quality of life, and lymphedema. DISCUSSION: Several studies compare the use of sealant products in axillary lymphadenectomy but generally with drains. We would like to demonstrate that patients who underwent axillary lymphadenectomy could benefit from an axillary sealant without drains and reduce axillary discomfort while maintaining a good quality of life. Assessing the relationship between axillary volume, symptoms, and related risk factors can be of great help in the control of seroma in patients who received breast cancer surgery. TRIAL REGISTRATION: ClinicalTrials.gov, NCT05280353. Registration date 02 August 2022.

Seroma formation after mastectomy: A systematic review and network meta-analysis of different flap fixation techniques.

Flap fixation is the most promising solution to prevent seroma formation after mastectomy. In this systematic review with network meta-analysis (NMA), three different techniques were compared. The NMA included 25 articles, comprising 3423 patients, and revealed that sutures are superior to tissue glue in preventing clinically significant seroma. In addition, running sutures seemed to be superior to interrupted sutures. An RCT comparing these suture techniques seems necessary, given the quality and nature of existing literature.

Do surgical drains reduce the postoperative surgical complications following incisional hernia repair? A systematic meta-analysis.

PURPOSE: Abdominal surgeries are common surgical procedures worldwide. Incisional hernias commonly develop after abdominal wall surgery. Surgery is the definite treatment for most incisional hernias but carries a higher rate of complications. Although frequently used, the real benefit of using drain tubes to reduce surgical complications after incisional hernia repair is uncertain. METHODS: PubMed and Embase databases were searched for studies that compared the outcomes of drain vs. no-drain placement and the risk of complications in patients undergoing incisional hernia repair. Primary endpoints were infection, seroma formation, length of hospital stay, and readmission rate. RESULTS: From a total of 771 studies, we included 2 RCTs and 4 non-RCTs. A total of 40,325 patients were included, of which 28 497 (71%) patients used drain tubes, and 11 828 (29%) had no drains. The drain group had a significantly higher infection rate (OR 1.89; CI 1.13-3.16; P = 0.01) and mean length of hospital stay (Mean Difference-MD 2.66; 95% CI 0.81-4.52; P = 0.005). There was no difference in seroma formation and the readmission rate. CONCLUSION: This comprehensive systematic meta-analysis concluded that drain tube placement after incisional hernia repair is associated with increased infection rate and length of hospital stay without affecting the rate of seroma formation and readmission rate. Prospective randomized studies are required to confirm these findings.

The early postoperative effects of rinsing the breast pocket with tranexamic acid in prepectoral prosthetic breast reconstruction.

BACKGROUND: The efficacy of tranexamic acid (TXA) has been reported in breast surgery; however, its application and duration have varied across studies. This study aimed to assess the early postoperative outcomes of rinsing the breast pocket with TXA during prepectoral prosthetic breast reconstruction using an acellular dermal matrix (ADM). METHODS: A retrospective chart review was conducted in consecutive patients who underwent immediate prosthetic prepectoral reconstruction between August 2021 and December 2022. For cases performed during the earlier part of the study period (up to April 2022), TXA was not administered (non-TXA group), whereas those performed after April 2022 received topical TXA application during surgery (TXA group). Postoperative outcomes including hematoma, seroma, drainage volume, and drain maintenance duration were compared between the two groups using propensity score matching (PSM). RESULTS: A total of 674 breasts were analyzed; 280 in the TXA group and 394 were in the non-TXA group. There were 251 breasts in each group after PSM, and their characteristics were similar. The incidence of hematoma in the first 24 hours and total drain output were significantly lower in the TXA group than the non-TXA group. In cases of direct-to-implant cases, the TXA group showed a significantly lower seroma rate. CONCLUSIONS: Rinsing the breast pocket with TXA can potentially reduce the occurrence of hematoma and decrease drain output in prepectoral ADM-assisted prosthetic breast reconstruction. Moreover, this approach may be beneficial in lowering the incidence of seroma in direct-to-implant reconstruction.

Drain-free mastectomy and flap fixation: The interim analysis of a randomized controlled noninferiority trial.

INTRODUCTION: Flap fixation after mastectomy has proven to be one of the most promising solutions to reduce seroma formation. Drain placement remains standard practice in many clinics, even though this may be redundant after flap fixation. METHODS: This is a prospective randomized controlled trial comparing mastectomy and wound closure using flap fixation with or without drain placement. The primary outcome measure was clinically significant seroma (CSS) incidence. The aim of this interim analysis was to assess the assumptions for the sample size calculation and to provide preliminary results. RESULTS: Between July 2020 and January 2023, 112 patients were included. CSS incidence was 9.1% in the drain group and 21% in the no-drain group. In total, 10 patients were lost to follow-up. These numbers are similar to the ones used for the sample size calculation. In the drain group, three patients required interventions for wound complications compared to nine in the no-drain group (odds ratio: 3.612 [95% confidence interval: 0.898-14.537]). CONCLUSION: The sample size calculation seems to be correct and no protocol amendments are necessary. Current preliminary results show no significant differences in CSS incidence. Complete results should be awaited to draw a well-powered conclusion regarding drain policy after mastectomy.

Reduction in Seroma Rate Following Deep Inferior Epigastric Perforator Flap with Umbilectomy Utilizing Progressive Tension Sutures.

BACKGROUND: Umbilectomy has been implemented in both abdominoplasties and deep inferior epigastric perforator (DIEP) flaps to improve abdominal wound healing and better control the location of the neoumbilicus; however, seroma rates are increased. The objective of this study is to compare the seroma rate following DIEP flap reconstruction with umbilectomy when progressive tension sutures (PTS) are implemented. METHODS: A retrospective chart review was performed to evaluate postoperative seroma rates in patients undergoing DIEP flap breast reconstruction at a single academic institution between January 2015 and September 2022. All procedures were performed by two senior surgeons. Patients were included if their umbilicus was removed intraoperatively. PTS were utilized in all abdominal closures beginning in late February 2022. Demographics, comorbidities, and postoperative complications were evaluated. RESULTS: A total of 241 patients underwent DIEP flap breast reconstruction with intraoperative umbilectomy. Forty-three consecutive patients received PTS. Overall complications were significantly lower in those who received PTS (p = 0.007). There were no abdominal seromas (0%) in patients who received PTS, whereas 14 (7.1%) occurred without PTS. The use of PTS conferred a decreased likelihood of abdominal seroma (5.687× lower risk, p = 0.017). Additionally, wound formation was significantly lower in those who received PTS (p = 0.031). CONCLUSION: The use of PTS in the abdominal closure during DIEP flap reconstruction addresses the previously seen rise in seroma rates when concomitant umbilectomy is performed. Decrease in both donor-site wounds and now seroma rates reaffirm the efficacy of removing the umbilicus to improve patient outcomes.

Prospective Study on Avoiding Seroma Formation by Flap Fixation After Modified Radical Mastectomy.

INTRODUCTION: Seroma development after mastectomy is a common complication. Continued seroma causes increased outpatient visits, repeated aspirations, infection, delayed healing, delayed adjuvant therapy, and increased cost. Various treatments are being attempted to prevent and reduce seroma development. We examined the effects of flap fixation on seroma using absorbable sutures after modified radical mastectomy (MRM). METHODS: The prospectively recorded data of patients who underwent surgery for breast cancer were analyzed retrospectively. 72 consecutive patients who underwent MRM were included in the study. Patients who underwent MRM in the same way by the same surgeon were divided into two groups: the group whose wound was closed by fixing the flap to the chest wall with an absorbable suture (group A), and the group whose wound was closed with the classical method (group B). The groups were compared in terms of seroma development, clinicopathological data, and early complications. RESULTS: Drain removal time and the total amount of drained fluid in group A patients were significantly lower than drain removal time and the total amount of drained fluid in group B patients (P < .001). Similarly, the amount of aspirated seroma in the control examinations of group A patients was significantly lower than that in group B (P < .05). Group B needed re-aspiration significantly more than group A (P < .05). CONCLUSIONS: Flap fixation with suture after MRM is a method that reduces seroma formation and the amount of drained fluid, enables early removal of the drain, prevents delay in starting adjuvant treatment, is more comfortable for the patient and physician, and is also inexpensive.

Role of methylprednisolone in the prevention of seroma formation after mastectomy: A randomized controlled trial.

Background: Seroma formation after mastectomy with axillary dissection is a major source of morbidity and results in a significant delay in starting the adjuvant treatment. Many different strategies, including the usage of steroids, have been tried to reduce the incidence of seroma with varying outcomes. This study aimed to assess the effect of a single dose of intracavitary methylprednisolone (MP) on seroma formation in patients undergoing total mastectomy with axillary lymph node dissection (ALND). Methods: A randomized controlled trial was conducted at our institute, from January 2018 till June 2019. In the intervention group of 36 patients, 80 mg of MP solution was injected into the wound on post operative day 1. The drain was clamped for 8 hours and then released. In the control group of 36 patients, saline was administered and the drain output was compared between the groups. Results: The mean drain volume in the intervention group was 409.08 mL and in the control group it was 566.97 mL (P < 0.005). The mean drain removal time was 7.86 days and 10.33 days in the intervention and control group, respectively (P < 0.0004). Conclusion: A single dose of intracavitary MP significantly reduced seroma formation and facilitated early removal of drain in patients undergoing total mastectomy with ALND.

Effectiveness of 3-Day Prophylactic Negative Pressure Wound Therapy on Closed Abdominal Incisions in the Prevention of Wound Complications: A Randomized Controlled Trial.

OBJECTIVE: To determine the impact of negative pressure wound therapy of closed abdominal incisions on wound complications. BACKGROUND: Surgical wound complications including surgical site infection complicating open abdominal operations are a burden on the economy. The outcomes of SSI include prolonged hospital stays, adjuvant treatment delay, and incisional hernias leading to a decrease in the quality of life. Prophylactic negative pressure wound therapy has recently been tried with promising results. METHODS: A randomized controlled trial involving 140 patients post-laparotomy with primary wound closure was divided into 2 groups (70 patients each). For the first group, NPWT dressings were applied for the first 3 days and then conventional dressings for 4 days after. For the second group, conventional dressings were applied for 7 days. Patients were followed up for SSI, seroma, wound dehiscence, and hospital stay. RESULTS: pNPWT was associated with a significantly lower rate of SSI development compared with gauze dressings (3/70 vs. 17/70) (p = 0.001). It also had a significant effect on lowering the incidence of seroma (0/70 vs. 7/70) (p = 0.007) and delayed wound healing (0/70 vs. 8/70) (p = 0.006) and on decreasing days of hospital stay (2.2 ± 0.6 vs. 3.5 ± 1.8) (p <0.00001). No significant difference was observed with regard to hematoma (0/70 vs. 1/70) (p = 0.5) or wound dehiscence (0/70 vs. 2/70) (p = 0.5). No burst abdomens or NPWT complications were recorded in our study. CONCLUSION: Three-day NPWT applied to primarily closed incisions is effective in reducing the incidence of SSI, seroma, and delayed wound healing in abdominal operations compared to conventional gauze dressings.

Postbariatric Abdominoplasty: A Comparative Study on Scarpa Fascia Preservation Versus Classical Technique.

BACKGROUND: Abdominoplasties performed with Scarpa Fascia preservation, improve recovery and reduce complications, particularly seroma. Bariatric patients who experience massive weight loss frequently seek body contouring procedures and represent a high-risk group. This study aimed to evaluate the effects of abdominoplasty with Scarpa Fascia preservation versus the classical technique in a bariatric population. METHODS: A retrospective observational cohort study was performed between March 2015 and March 2021 in 65 postbariatric patients who underwent a classic full abdominoplasty (group A, N = 25) or a similar procedure except for the preservation of Scarpa fascia (group B, N = 40). Total and daily drain output, time until drain removal, long drainers (≥ 6 days), length of hospital stay, emergency department visit, readmission to the hospital, reoperation, local and systemic complications were the outcomes evaluated. RESULTS: Group B had a 3-day reduction in time until drain removal (p < 0.001), a 62.6% reduction of total drain output (p < 0.001) and a 3-day reduction in the length of the hospital stay (p < 0.001). Long drainers (≥ 6 days) were highly reduced (from 56.0% in group A to 7.5% in group B) (p < 0.001). There was a lower incidence of liquid collections in group B, with a 66.7% reduction in seroma incidence. CONCLUSIONS: Abdominoplasty with Scarpa Fascia preservation improves recovery by reducing drain output, allowing earlier drain removal and reducing long periods with suction drains. It also reduces hospital stay and seroma incidence. This technique modifies the high-risk postbariatric patient in such a major way that he behaves like a nonbariatric. LEVEL OF EVIDENCE II: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Clinical Evaluation of 310 Abdominoplasties and Measurement of Scar Level.

BACKGROUND: Most published studies on abdominoplasty focus on methods to reduce the risk of seromas. These methods include limited dissection (lipoabdominoplasty), quilting sutures, and preservation of the Scarpa fascia. Quantitative evaluation of the aesthetic result has been lacking. METHODS: A retrospective study was undertaken of all patients undergoing abdominoplasty in the author's practice from 2016 to 2022. A full abdominoplasty was performed, usually with liposuction (87%). All patients were treated under total intravenous anesthesia without paralysis or prone positioning. A single closed suction drain was removed 3 or 4 days after surgery. All procedures were performed as outpatients. Ultrasound surveillance was used to detect any deep venous thromboses. No patient received chemoprophylaxis. The operating table was flexed, often to 90°. Deep fascial anchoring sutures were used to attach the Scarpa fascia of the flap to the deep muscle fascia. Measurements of the scar level were made at intervals after surgery up to 1 year. RESULTS: Three hundred ten patients were evaluated, including 300 women. The mean follow-up time was 1 year. The overall complication rate, which included minor scar deformities, was 35.8%. Five deep venous thromboses were detected. There were no hematomas. Fifteen patients (4.8%) developed seromas that were successfully treated by aspiration. The mean vertical scar level 1 month after surgery was 9.9 cm (range, 6.1-12.9 cm). There was no significant change in scar level at subsequent follow-up times up to 1 year. By comparison, the scar level in published studies ranged from 8.6 to 14.1 cm. DISCUSSION: Avoidance of electrodissection reduces tissue trauma that causes seromas. Flexed patient positioning during surgery and deep fascial anchoring sutures are effective in keeping the scar low. By avoiding chemoprophylaxis, hematomas can be avoided. Limiting the dissection (lipoabdominoplasty), preserving the Scarpa fascia, and adding quilting (progressive tension) sutures are unnecessary. CONCLUSIONS: Total intravenous anesthesia offers important safety advantages. Avoiding electrodissection is effective in keeping seroma rates at a tolerable level (5%), and the scar low and more easily concealed. Alternative methods present disadvantages that may contribute to a suboptimal aesthetic result and require additional operating time.

Efficacy of intraoperative hypertonic saline irrigation in seroma prevention after abdominal wall reconstruction procedures - a pilot cohort study.

INTRODUCTION: Seromas refer to collections of fluid secreted into the so-called dead spaces when extensive dissection takes place. Various methods of preventing seroma have been reported in the literature but their outcomes are far from spectacular. AIM: To verify the expected benefit on usage of IHSI (intra-operative hypertonic saline irrigation) in aspect of decreasing subcutaneous fluid secretion and decreased hospital stay in patients undergoing various abdominal wall reconstruction procedures. MATERIAL AND METHODS: We conducted a cohort study of total 64 patients treated by two techniques and divided into 2 groups. In the first group (SUBLAY), we assessed patients undergoing abdominal wall reconstruction with the positioning mesh underneath the rectus muscles. Group was divided into two subgroups: control and experimental. In second group (ONLAY), we analysed patients who had undergone reconstruction procedure combined with abdominoplasty and placement of a mesh between the subcutaneous tissue and the fascia. Intervention consisted in administration of 20 mL of 10% hypertonic saline into subcutaneous tissue 10 min before definitive wound closure. RESULTS: Mean drain output, starting from day 2 post-op, was significantly lower in the experimental subgroups of the ONLAY and SUBLAY compared to the respective control subgroups. This had a beneficial effect on shortening the time to drainage removal. CONCLUSIONS: In the short-term results, we demonstrated that intraoperative hypertonic saline irrigation significantly decreased the amount of the drained fluid and shortened the hospital stay. Further multicentre studies in larger groups of patients are needed.

Efficacy and safety of surgical energy devices for axillary node dissection: a systematic review and network meta-analysis.

Various surgical energy devices are used for axillary lymph-node dissection. However, those that reduce seroma during axillary lymph-node dissection are unknown. We aimed to determine the best surgical energy device for reducing seroma by performing a network meta-analysis to synthesize the current evidence on the effectiveness of surgical energy devices for axillary node dissection for breast cancer patients. We searched MEDLINE, Embase, CENTRAL, ClinicalTrials.gov, and World Health Organization International Clinical Trials Platform Search Portal. Two reviewers independently selected randomized controlled trials (RCTs) comparing electrosurgical bipolar vessel sealing (EBVS), ultrasonic coagulation shears (UCS), and conventional techniques for axillary node dissection. Primary outcomes were seroma, drained fluid volume (mL), and drainage duration (days). We analyzed random-effects and Bayesian network meta-analyses. We evaluated the confidence of each outcome using the CINeMA tool. We registered with PROSPERO (CRD42022335434). We included 34 RCTs with 2916 participants. Compared to the conventional techniques, UCS likely reduces seroma (risk ratio [RR], 0.61; 95% credible interval [CrI], 0.49-0.73), the drained fluid volume (mean difference [MD], - 313 mL; 95% CrI - 496 to - 130), and drainage duration (MD - 1.79 days; 95% CrI - 2.91 to - 0.66). EBVS might have little effect on seroma, the drained fluid volume, and drainage duration compared to conventional techniques. UCS likely reduce seroma (RR 0.44; 95% CrI 0.28-0.69) compared to EBVS. Confidence levels were low to moderate. In conclusion, UCS are likely the best surgical energy device for seroma reduction during axillary node dissection for breast cancer patients.

Effect of different quilting techniques on seroma formation after breast surgery: retrospective study.

BACKGROUND: Quilting, a technique in which skin flaps are sutured to the underlying muscle, reduces seroma after mastectomy and/or axillary lymph node dissection. The aim of this study was to assess the effect of different quilting techniques on the formation of clinically significant seroma. METHODS: This was a retrospective study including patients undergoing mastectomy and/or axillary lymph node dissection. Four breast surgeons applied the quilting technique based on their own discretion. Technique 1 was performed using Stratafix in 5-7 rows placed at 2-3 cm distance. Technique 2 was performed using Vicryl 2-0 in 4-8 rows placed at 1.5-2 cm distance. Technique 3 was performed using Vicryl 0/1 in 3 rows placed at 3-4 cm distance. Technique 4 was performed using Vicryl 0 in 4-5 rows placed at 1.5 cm distance. The primary outcome was clinically significant seroma. RESULTS: A total of 445 patients were included. Clinically significant seroma incidence was 4.1 per cent (six of 147) for technique 1, which was significantly lower than that for the other techniques (25.0 per cent (29 of 116), 29.4 per cent (32 of 109), and 33 per cent (24 of 73) for techniques 2, 3, and 4 (P < 0.001) respectively). The duration of surgery was not significantly longer for technique 1 compared with the other three techniques. The length of hospital stay, number of additional visits to the outpatient clinic, and reoperations did not differ significantly between the four techniques. CONCLUSION: Quilting using Stratafix and placing 5-7 rows with 2-3 cm distance between the stitches associates with low clinically significant seroma incidence without adverse effects.

The Effects of Tranexamic Acid in Breast Surgery: A Systematic Review and Meta-Analysis.

BACKGROUND: Tranexamic acid (TXA) is used in trauma and surgical settings. Its role in reducing postoperative blood loss in breast surgery remains unclear. The primary objective of this study was to determine the effect of TXA on postoperative blood loss in breast surgery. METHODS: Searches of the PubMed, Ovid MEDLINE, Embase, CINAHL, and Cochrane Central Register of Controlled Trials databases were performed from inception to April 3, 2020. Inclusion criteria were any retrospective reviews, prospective cohort studies, and randomized controlled trials that administered TXA (topical or intravenously) in the context of breast surgery. Quality of studies were evaluated using the risk of bias in randomized trials tool and the risk of bias in nonrandomized studies of interventions tool. Data were pooled, and a meta-analysis was performed. RESULTS: In total, seven studies were included, representing 1226 patients (TXA, 632 patients; control, 622 patients). TXA was administered as follows: topically (20 mL of 25 mg/mL TXA intraoperatively; n =258 patients), intravenously (1 to 3 g perioperatively; n = 743 patients), or both (1 to 3 g daily up to 5 days postoperatively; n = 253 patients). TXA administration reduced hematoma formation in breast surgery (risk ratio, 0.48; 95% CI, 0.32 to 0.73), with no effect on drain output (mean difference, -84.12 mL; 95% CI, -206.53 to 38.29 mL), seroma formation (risk ratio, 0.92; 95% CI, 0.60 to 1.40), or infection rates (risk ratio, 1.01; 95% CI, 0.46 to 2.21). No adverse effects were reported. CONCLUSION: The use of TXA in breast surgery is a safe and effective modality with low-level evidence that it reduces hematoma rates without affecting seroma rates, postoperative drain output, or infection rates.

Tranexamic Acid Use in Breast Surgery: A Systematic Review and Meta-Analysis.

BACKGROUND: The perioperative use of tranexamic acid (TXA) has become popular among plastic surgeons for a variety of surgical procedures. The aim of this study was to perform a systematic review and meta-analysis on the results reported in the literature regarding the effect of perioperative systemic TXA administration in breast surgery. METHODS: The PubMed, MEDLINE, Embase, CENTRAL, and CINAHL databases were searched for both randomized clinical trials and observational studies. Effect estimates were pooled across studies using random effects models and presented as weighted odds ratio with corresponding 95% confidence interval. RESULTS: A total of five studies encompassing 1139 patients undergoing mastectomy with or without immediate implant or free flap-based breast reconstruction or breast-conserving surgery with or without axillary lymph node dissection were included. Perioperative intravenous administration of TXA significantly reduced the risk for hematoma (7.3% versus 12.9%; OR, 0.43; 95% CI, 0.23 to 0.81) and seroma formation (11.5% versus 19.9%; OR, 0.57; 95% CI, 0.35 to 0.92) in comparison to the control group. In the studies measuring the postoperative drainage amount, the mean difference was 132 mL (95% CI, 220 to 44 mL). No thromboembolic event occurred in either group. The weighted surgical-site infection rate was higher in the control group (3.1% versus 1.5%). However, these data were too sparse to perform comparative meta-analysis. CONCLUSION: Evidence of this study suggests that perioperative administration of TXA significantly reduces the risk for postoperative hematoma and seroma formation in breast surgery, whereas the risk for thromboembolic events and postoperative infection is not increased.

Bilateral prophylactic mastectomy: should we preserve the pectoral fascia? Protocol of a Dutch double blinded, prospective, randomised controlled pilot study with a within-subject design (PROFAS).

INTRODUCTION: Bilateral prophylactic mastectomy (BPM) in women with a high risk of developing breast cancer has shown to provide the greatest risk reduction. Many surgical guidelines recommend the removal of the pectoral fascia (PF) in mastectomies; however, there is no evidence to support this statement. Reported wound-related complications following mastectomy include seroma, flap necrosis, infection and haematoma. Seroma causes discomfort and may delay the reconstructive procedures. Whether removal or preservation of the PF influences drain volume, seroma formation and other postoperative complications following BPM remains unclear. The aim of this study is to assess the impact of removal versus preservation of the PF on drain policy and seroma after BPM. METHODS AND ANALYSIS: This is a double blinded, prospective, randomised controlled pilot study with a within-subject design. The inclusion criteria are women >18 years, presenting in the Academic Breast Cancer Centre Rotterdam, who are opting for BPM. Patients with a history or diagnosis of breast cancer are excluded. According to the sample size calculation based on the difference in total drain volume, a number of 21 eligible patients will be included. Randomisation will occur within the patient, which means PF preservation in one breast and PF removal in the contralateral breast. The primary study endpoint is total drainage volume. Secondary study outcomes include time to drain removal, number of needle aspirations, postoperative complications and length of hospital stay. ETHICS AND DISSEMINATION: The study is approved by the Erasmus Medical Center Review Board (REC 2020-0431). Results will be presented during international conferences and published in a peer-reviewed academic journal. TRIAL REGISTRATION NUMBER: NCT05391763; clinicaltrials.gov.