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.

Evidence to support a drain-free strategy in kidney transplantation using a retrospective comparison of 500 consecutively transplanted cases at a single center.

INTRODUCTION: Routine placement of surgical drains at the time of kidney transplant has been debated in terms of its prognostic value. OBJECTIVES: To determine whether the placement of a surgical drain affects the incidence rate of developing wound complications and other clinical outcomes, particularly after controlling for other prognostic factors. METHODS: Retrospective analysis of 500 consecutive renal transplant cases who did not (Drain-free, DF) vs. did (Drain, D) receive a drain at the time of transplant was performed. The primary outcome was the development of any wound complication (superficial or deep) during the first 12 months post-transplant. Secondary outcomes included the development of superficial wound complications, deep wound complications, DGF, and graft loss during the first 12 months post-transplant. RESULTS: 388 and 112 recipients had DF/D, respectively. DF-recipients were significantly more likely to be younger, not have pre-transplant diabetes, receive a living donor kidney, receive a kidney-alone transplant, have a shorter duration of dialysis, shorter mean cold-ischemia-time, and greater pre-transplant use of anticoagulants/antiplatelets. Wound complications were 4.6% (18/388) vs. 5.4% (6/112) in DF vs. D groups, respectively (P = 0.75). Superficial wound complications were observed in 0.8% (3/388) vs. 0.0% (0/112) in DF vs. D groups, respectively (P = 0.35). Deep wound complications were observed in 4.1% (16/388) vs. 5.4% ((6/112) in DF vs. D groups, respectively (P = 0.57). Higher recipient body mass index and ≥ 1 year of pre-transplant dialysis were associated in multivariable analysis with an increased incidence of wound complications. Once the prognostic influence of these 2 factors were controlled, there was still no notable effect of drain use (yes/no). The lack of prognostic effect of drain use was similarly observed for the other clinical outcomes. CONCLUSIONS: In a relatively large cohort of renal transplant recipients, routine surgical drain use appears to offer no distinct prognostic advantage.

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.

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. METHODS: This is a randomized controlled trial in female breast cancer patients undergoing mastectomy and flap fixation using sutures with or without sentinel lymph node biopsy (SLNB). Patients will be eligible for inclusion if they are older than 18 years, have an indication for mastectomy with or without sentinel procedure. Exclusion criteria are modified radical mastectomy, direct breast reconstruction, previous history of radiation therapy of the unilateral breast, breast conserving therapy and inability to give informed consent. A total of 250 patients will be randomly allocated to one of two groups: mastectomy combined with flap fixation and closed-suction drainage or mastectomy combined with flap fixation without drainage. Follow-up will be conducted up to six months postoperatively. The primary outcome is the proportion of patients undergoing one or more seroma aspirations. Secondary outcome measures consist of the number of invasive interventions, surgical site infection, quality of life measured using the SF-12 Health Survey, cosmesis, pain and number of additional outpatient department visits. DISCUSSION: To our knowledge, no randomized controlled trial has been conducted comparing flap fixation with and without closed-suction drainage with seroma aspiration as the primary outcome. This study could result in finding evidence that supports performing mastectomy without closed-suction drainage. TRIAL REGISTRATION: This trial was approved by the medical ethical committee of Zuyderland Medical Center METC-Z on 20 March 2019 (METCZ20190023). The SARA Trial was registered at ClinicalTrials.gov as per July 2019, Identifier: NCT04035590 .

Increasing the incidence of drain-free day-case mastectomies with the use of a fibrin tissue sealant; data from a single surgical center in the United Kingdom.

Day-case mastectomy surgery provides benefits to both patients and hospitals. Key barriers are the use of a drain and the risk of postoperative seroma formation. We introduced the use of a tissue sealant (Artiss) into the surgical site (post-mastectomy without immediate reconstruction and postaxillary clearance) and evaluated its effect on our practice, particularly day-case rates. A prospective audit of 177 patients who underwent a simple mastectomy with or without axillary surgery, or axillary node clearance with or without breast-conserving surgery was conducted at a single surgical center in the UK between November 2015 and November 2016. Artiss was used in all operations and, where appropriate, the drain was omitted to facilitate day-case surgery. The clinical outcomes were compared between patients undergoing different operations and duration of hospital stay. There was no statistically significant difference between day-case patients and inpatients in seroma aspiration rates (24.5% and 21.7%, respectively; P = 0.381) or other complications (22.4% and 16.1%, respectively; P = 0.106). The day-case mastectomy rate increased from 3.9% in the first quarter to 45.5% in the final quarter, which was a significant increase reaching well beyond the national target. The use of Artiss enabled us to increase the drain-free day-case surgery rates over a 1-year period, exceeding the 30% target recommended by the British Association of Day Surgery. We did not observe any increase in patient morbidity, and the change was cost-effective. We have now implemented the routine use of Artiss in women undergoing simple mastectomy with or without axillary surgery and stand-alone axillary node clearances as part of enhanced recovery clinical pathways.

Drain-free donor site in Deep Inferior Epigastric Perforator free flap: A single-surgeon experience.

Donor-site seroma and wound dehiscence in Deep Inferior Epigastric Perforator (DIEP) free flaps can be problematic. The value of donor-site drains is debated, with alternative closure techniques demonstrating good outcomes. However, no literature exists on patient outcomes in which no drain or dead space reduction technique is used. The senior author of this paper has opted for a drain-free, simple layered closure without adjuncts since 2016. We evaluate the outcomes of this technique against the literature. A single-center, single-surgeon, prospective study of all DIEP flap breast reconstruction between January 2016 and March 2020, whereby the donor site was closed without drains or alternative dead space reduction measures. One hundred and thirty-eight patients with a mean age of 50.72±9.16 (range 26-73) underwent DIEP breast reconstruction (78% unilateral (n = 107), 22% bilateral (n = 31). The incidence of drain-free specific donor-site complications was 9.4%, with wound breakdown being the most common (9/138, 6.5%). However, only one patient required secondary closure. The average length of hospital stay was 4.2±1 days (range 2-9). Abdominal drains may serve as a psychological barrier for patients in expediting discharge and can be painful and cumbersome. This translates into significant cost implications. Evidence suggests that superior outcomes are achieved when dead space-reducing adjuncts rather than drains are used. However, our data suggest that DIEP donor sites can also be safely closed without these adjuncts, which may unnecessarily lengthen procedure time, consume more resources, and increase localized foreign body tissue reactions, without good indication.

A systematic review of seroma formation following drain-free mastectomy.

BACKGROUND: Seroma is a common complication after mastectomy. The aim of this review is to elucidate whether closed suction drainage can safely be omitted in patients undergoing mastectomy when assessing seroma formation and its complications. The second aim is to assess the influence of flap fixation on seroma related complications, as there is existing evidence showing that combining mastectomy with flap fixation may make the use of drainage systems obsolete. SEARCH & SELECTION: A review of the literature was performed and articles that compared mastectomy with drainage and mastectomy without drainage were selected. Due to the small number of eligible studies, no selection based on whether flap fixation was performed was possible. If outcome was described in terms of seroma formation or seroma related complications, papers were eligible for inclusion. Studies older than 20 years, animal studies, studies not written in English and studies with male patients were excluded. RESULTS: A total of eight articles were eligible for inclusion. Four prospective studies and four retrospective studies were included. In four studies, flap fixation was performed. Frequency of seroma formation as well as seroma that required intervention was reported. The included studies demonstrated that omitting closed suction drainage does not lead to a higher incidence of seroma formation in patients undergoing mastectomy. CONCLUSION: Despite substantial heterogeneity, there is evidence that drainage can safely be omitted without exacerbating seroma formation and its complications. A well-powered, randomized controlled trial evaluating the effect of drainage omission on seroma formation, with or without flap fixation, is needed.

Potential Risk Factors Influencing the Formation of Postoperative Seroma After Breast Surgery - A Prospective Study.

BACKGROUND/AIM: This trial intended to identify patient- and therapy-specific risk factors influencing the genesis of seroma and the extent of its formation. PATIENTS AND METHODS: Within a prospective randomized controlled trial, 70 patients (n=35 TissuGlu®; n=35 drain) underwent a mastectomy with or without sentinel lymphonodectomy. Specific seroma-associated risk factors were recorded. Regular outpatient aftercare was performed during a 90-day postoperative follow-up. RESULTS: A statistically significant increase in the postoperative seroma rate was demonstrated for those with pre-adiposity compared to normal body weight (p=0.016), as well as for the state of health evaluated by the score of American Society of Anesthesiologists (ASA) (ASA III compared to I; p=0.046), the presence of diabetes mellitus (p<0.001) and the reduction of the length of the surgical procedure (p=0.044). CONCLUSION: A high body mass index, a poor state of health (ASA score), and diabetes mellitus, as well as a shorter duration of surgery, favor the incidence of postoperative seroma.

Drainless Abdominoplasty Using Progressive Tension Sutures.

Drain-free abdominoplasty using progressive tension sutures (PTS) was initially described in 2000 in a small retrospective series. However, the authors' experience with this technique spans well over 3 decades, and their technique has evolved to simplify the procedure to make it easier and more reproducible by the surgeon and improve the patient's recovery and overall experience. This article provides in-depth technical details on the authors' no-drain abdominoplasty technique. The authors also address through recent literature some of the commonly stated barriers to surgeons instituting this technique into their abdominoplasty procedure, including excessive time of placement, dimpling, and effectiveness.

Impact of the Lysine-urethane Adhesive TissuGlu® on Postoperative Complications and Interventions After Drain-free Mastectomy.

BACKGROUND/AIM: The influence of a polyurethane-based tissue adhesive (TissuGlu®) on common complications following breast surgery was investigated. PATIENTS AND METHODS: Within a Randomized-Controlled-Trial 70 women (n=35 TissuGlu®, n=35 drain) underwent a mastectomy with or without sentinel lymph node excision (SLNE), followed by a 90-day postoperative follow-up. RESULTS: Postoperative interventions: Non-inferiority of the application of TissuGlu® was seen. Pain-Level/ Hospitalization: A statistically significant pain reduction from day four onwards (p<0.001) and a shorter hospitalization period (p<0.001) was observed. In contrast, the TissuGlu® group showed increased mean puncture incidence (p=0.013), and increased puncture volume (p=0.021). CONCLUSION: Application of the polyurethane-based tissue adhesive TissuGlu® after mastectomy, with or without SLNE, showed potential for improvement of the clinical outcome. In contrast, high intervention rates and increased puncture volume, caused by recurring seromas following application of the surgical adhesive TissuGlu®, have a negative impact on the patient-specific convalescence.