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.

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.

The QUILT study: quilting sutures in patients undergoing breast cancer surgery: a stepped wedge cluster randomized trial study.

BACKGROUND: Seroma is the most common complication following breast cancer surgery, with reported incidence up to 90%. Seroma causes patient discomfort, is associated with surgical site infections (SSI), often requires treatment and increases healthcare consumption. The quilting suture technique, in which the skin flaps are sutured to the pectoralis muscle, leads to a significant reduction of seroma with a decrease in the number of aspirations and surgical site infections. However, implementation is lagging due to unknown side effects, increase in operation time and cost effectiveness. Main objective of this study is to assess the impact of large scale implementation of the quilting suture technique in patients undergoing mastectomy and/or axillary lymph node dissection (ALND). METHODS: The QUILT study is a stepped wedge design study performed among nine teaching hospitals in the Netherlands. The study consists of nine steps, with each step one hospital will implement the quilting suture technique. Allocation of the order of implementation will be randomization-based. Primary outcome is 'textbook outcome', i.e.no wound complications, no re-admission, re-operation or unscheduled visit to the outpatient clinic and no increased use of postoperative analgesics. A total of 113 patients is required based on a sample size calculation. Secondary outcomes are shoulder function, cosmetic outcome, satisfaction with thoracic wall and health care consumption. Follow-up lasts for 6 months. DISCUSSION: This will be one of the first multicentre prospective studies in which quilting without postoperative wound drain is compared with conventional wound closure. We hypothesize that quilting is a simple technique to increase textbook outcome, enhance patient comfort and reduce health care consumption.

Technical aspects of flap fixation after mastectomy for breast cancer: Guidelines for improving seroma-related outcome.

OBJECTIVES: Previous studies have identified the added value of flap fixation in reducing seroma formation and its sequelae after mastectomy. The seroma reduction after mastectomy (SAM)-trial proved that sutures were superior to tissue glue. In this article, we will elaborate on the results of the SAM-trial to provide a clear surgical guideline. METHODS: All patients in the suture flap fixation cohort from the SAM-trial were analyzed if details regarding flap fixation were available. The most optimal number of sutures was determined using a receiving operator characteristics curve. The incidence of seroma formation between patients receiving the most optimal number of sutures and patients receiving fewer sutures was compared. RESULTS: The most optimal number of sutures proved to be 15. Patients with ≥15 sutures had a lower incidence of seroma formation at every time frame during follow-up. There was a significant difference at 6 weeks (odds ratio [OR]: 3.05, 95% confidence interval [CI]: 1.09-8.56), 3 months (OR: 4.62, 95% CI: 1.34-12.92), and 1 year postoperatively (OR: 20.48, 95% CI: 2.18-192.22). Ten days and 6 months postoperatively did not differ significantly. CONCLUSIONS: Flap fixation in general, but also the surgical technique influences the incidence of seroma formation after mastectomy. Results suggest a minimum of 15 sutures, spaced approximately 3.7 cm apart.

Anchored sutures for fixation of the anterolateral thigh flap and prevention of orocutaneous fistula in oral and oropharyngeal cancer reconstruction.

OBJECTIVE: This study aims to assess the efficacy of anchored sutures (AS) in securing the anterolateral thigh (ALT) flap during oral and oropharyngeal reconstructions, and its impact on the occurrence of orocutaneous fistula (OCF). MATERIALS AND METHODS: A retrospective study was performed on patients who underwent ALT flap reconstruction in our department in the year 2022. The patients were divided into two groups based on whether the AS technique was used. The incidence of OCF was compared between the two groups, and AS-related complications were reported. Fisher's exact test was employed to assess the differences in baseline characteristics and the incidence of OCF between the two groups. RESULTS: The study included 214 patients, with 156 in the conventional suture (CS) group and 58 in the AS group. The incidence of OCF in the AS group was significantly lower compared to that in the CS group (P = 0.039). However, there was a weak correlation between OCF and the AS technique (φ = -0.149). Among the 58 cases in the AS group, three (5.17%) experienced AS-related granuloma (ASRG) as complications. CONCLUSION: The use of ALT flap reconstruction with the AS technique reduces the incidence of OCF; however, ASRG may be a potential complication. CLINICAL RELEVANCE: This study demonstrates the effectiveness of AS technique in securing ALT flaps, leading to a decreased risk of OCF in oral and oropharyngeal defect reconstruction.

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 .

Technique for secondary modification after maxillary resection and reconstruction for soft tissue flap fixation before prosthesis addition: a case report.

BACKGROUND: The removal of maxillary carcinoma causes various types of tissue defects, which can be corrected by free flap reconstruction. In flap reconstruction after maxillary cancer resection, ensuring prosthesis stability is frequently difficult owing to the flap's weight. Therefore, a second modification technique is required for improvement of configuration. This case where flap suspension and flap modifying surgery were performed using anchor system for the extensive complete maxillectomy case. CASE PRESENTATION: The patient was a 56-year-old male, who underwent an extensive total maxillectomy and flap reconstruction using the rectus abdominus muscles in May 2005. Postoperatively, due to the difficulties of wearing a maxillary denture, he was transferred to our department with the chief complaint of morphological improvement. The maxillary bone had already been removed from the midline with the rectus abdominus muscle flap sutured directly to the soft palate without oral vestibule, and the flap margin was moving together with the surrounding soft tissue. The flap size was 70 × 50 mm, which was sagging due to its own weight and was in contact with mandibular molars, reducing the volume of the oral cavity without a denture being worn. Flap reduction and lifting the flap were performed under general anesthesia using 3 Mitek anchors implanted in the zygomatic bone, and the anchor suture was placed through the subcutaneous tissue to lift the flap. Postoperatively, the prosthesis was stable. No recurrence of flap sagging or wound infection was seen 3 years after surgery. CONCLUSIONS: The second modification technique after maxillary cancer resection is useful for ensuring prosthesis stability. This method can be used before prosthesis addition. We could obtain remarkable denture stability by flap suspension using anchor system and a flap-modifying operation for the patient who had undergone maxilloecotomy. The denture was stabilized by using anchors for the elevated flap and flap loss technique and by performing vestibuloplasty for support.

A systematic review of flap fixation techniques in reducing seroma formation and its sequelae after mastectomy.

BACKGROUND: Seroma formation is a common complication after mastectomy. This review aims to elucidate which surgical techniques are most effective in reducing the dead space and therefore seroma formation in patients undergoing mastectomy. METHODS: A literature search was performed to identify clinical studies comparing any form of flap fixation to conventional closure technique in patients undergoing mastectomy with or without axillary clearance. Studies were eligible for inclusion if outcome was described in terms of seroma formation and/or complications of seroma formation. Studies on animal research or breast reconstruction with tissue expanders or flap harvesting (latissimus dorsi) were excluded. RESULTS: A total of nine articles were eligible for inclusion. Five were retrospective studies and four were prospective. Retrospective and prospective studies have demonstrated the higher incidence of seroma formation in patients not undergoing mechanical flap fixation. The incidence of seroma-related complications in these studies vary. Four out of the nine studies demonstrate that patients undergoing flap fixation, need significantly fewer seroma aspirations. There are very few studies on the use of tissue glues preventing seroma formation. CONCLUSION: The scientific body of evidence favoring flap fixation after mastectomy is convincing. Mechanical flap fixation seems to reduce seroma formation and seroma aspiration after mastectomy. There are, however, no well-powered randomized controlled trials evaluating all aspects of seroma formation and its sequelae. Further research should elucidate whether flap fixation using sutures or tissue glue is superior.

A multi-center, double blind randomized controlled trial evaluating flap fixation after mastectomy using sutures or tissue glue versus conventional closure: protocol for the Seroma reduction After Mastectomy (SAM) trial.

BACKGROUND: Seroma formation is a common complication after mastectomy and is associated with delayed wound healing, infection, skin flap necrosis, patient discomfort and repeated visits to the out patient clinic to deal with seroma and its sequelae. Closing the dead space after mastectomy seems to be key in reducing seroma and its complications. Various methods have been described to reduce the dead space after mastectomy: closed suction drainage, quilting of the skin flaps and application of adhesive tissue glues. The aim of this trial is to compare seroma formation and its sequelae in the various methods of flap fixation. METHODS: This is a multicenter, double-blind, randomized controlled trial in female breast cancer patients undergoing mastectomy, with or without axillary clearance. Exclusion criteria consist of breast conserving therapy, direct breast reconstruction and incapacity to comprehend implications and extent of study and unable to sign for informed consent. A total of 336 patients will be randomized. Patients will be randomly allocated to one of three treatment arms consisting of flap fixation using ARTISS tissue glue with a low suction drain, flap fixation using sutures and a low suction drain or conventional wound closure (without flap fixation) and low suction drainage. Follow up will be conducted up to twelve months post surgery. The primary outcome is the number of seroma aspirations and secondary outcomes consist of number of out patient clinic visits, surgical skin infection rate, shoulder function, cosmesis, health-related quality of life and costs and cost-effectiveness (cost/QALY). DISCUSSION: This is the first study of its kind to evaluate the effect of flap fixation and its sequelae (ie seroma aspirations, number of out patient clinic visits, infection, shoulder function, patient assessed cosmesis, quality of life and cost-effectiveness) in a double blind randomized controlled trial. TRIAL REGISTRATION: This trial was approved by the hospitals' joint medical ethical committee (14-T-21, 2 June 2014). The SAM Trial is registered in ClinicalTrials.gov since October 2017, Identifier: NCT03305757 .

Craniotomy bone flap fixation: revisiting the use of bone struts.

INTRODUCTION: Bone flap fixation after craniotomy is a standard part of neurosurgical practice. Several techniques and devices exist, though no ideal strategy has been identified. The key aims are to prevent infection and to achieve adequate cosmesis and bony fusion whilst also minimising costs and complications. Ease of use must also be considered. Fixation with sutures and bony struts in the kerf has been described in children and adults and, although the technique achieves many of the ideals of fixation, it does not seem to have been popularised. We report our experience of using the strut technique. METHODS: A retrospective review of our cranial surgery database, operative notes and follow-up records was conducted. 300 applicable craniotomies were carried out in 8 years. Struts were used in 81 cases and comments on the bony contour described in 21 follow-up records. RESULTS: In nineteen, the contour was perfect. In one, there was a small bony depression; and in one, there was a small ridge in the posterior part. No repeat operations were carried out for surgery or cosmesis. CONCLUSIONS: We report our results with a view to reminding the neurosurgical community of the existence of a technique that achieves all the criteria of the ideal fixation strategy.

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.

Economic evaluation of flap fixation techniques after mastectomy: Results of a double-blind randomized controlled trial (SAM-trial).

BACKGROUND: An economic evaluation was performed alongside an RCT investigating flap fixation in reducing seroma formation after mastectomy. The evaluation focused on the first year following mastectomy and assessed cost-effectiveness from a health care and societal perspective. METHODS: The economic evaluation was conducted between 2014 and 2018 in four Dutch breast clinics. Patients with an indication for mastectomy or modified radical mastectomy were randomly assigned to: conventional closure (CON), flap fixation with sutures (FFS) or flap fixation with tissue glue (FFG). Health care costs, patient and family costs and costs due to productivity losses were assessed. Outcomes were expressed in incremental cost-effectiveness ratios (ICERs): the incremental cost per quality-adjusted life year (QALY). Bootstrapping techniques, sensitivity and secondary analyses were employed to address uncertainty. RESULTS: The FFS-group yielded most QALYs (0.810; 95%-CI 0.755-0.856), but also incurred the highest mean costs at twelve months (€10.416; 95%-CI 8.231-12.930). CON was the next best alternative with 0.794 QALYs (95%-CI 0.733-0.841) and mean annual costs of €10.051 (95%-CI 8.255-12.044). FFG incurred fewer QALYs and higher costs, when compared to the CON group. The ICER of FFS compared to CON was €22.813/QALY. Applying a willingness to pay threshold in the Netherlands of €20.000/QALY, the probability that FFS was cost-effective was 42%, compared to 37% and 21% for CON and FFG, respectively. CONCLUSION: The cost-effectiveness of FFS following mastectomy, versus CON and FFG, is uncertain from a societal perspective. Yet, from a health care and hospital perspective FFS is likely to be the most cost-effective intervention.

Effect of Peritoneal Fixation (PerFix) on Lymphocele Formation in Robot-assisted Radical Prostatectomy with Pelvic Lymphadenectomy: Results of a Randomized Prospective Trial.

BACKGROUND: Symptomatic lymphoceles present the most common complication of robot-assisted radical prostatectomy (RARP) with extended pelvic lymph node dissection (ePLND). No surgical technique has so far shown success in reducing the incidence rate, but several retrospective studies have shown the beneficial effect of the fixation of the peritoneum. OBJECTIVE: To introduce a modification in the technique of fixing the peritoneum to the pubic bone and to confirm whether this intervention reduces the incidence of lymphoceles. DESIGN, SETTING, AND PARTICIPANTS: A prospective randomized (1:1) single-center one-sided blind study was conducted in patients with localized prostate cancer (cT1-2cN0M0) indicated for RARP with ePLND operated between December 2019 and June 2021. In the intervention group, the free flap of the peritoneum was fixed to the pubic bone. In the control group, the peritoneal flap was left free without fixation. SURGICAL PROCEDURE: In the intervention group, the free flap of the peritoneum was fixed to the pubic bone (PerFix) so that lateral holes were left, allowing drainage of lymph from the pelvis into the abdominal cavity, where it would be resorbed. The iliac vessels and obturator fossa remained uncovered by the peritoneum and the bladder. MEASUREMENTS: The primary objective was to evaluate the frequency of symptomatic lymphoceles during follow-up. The secondary endpoints were the radiological presence of lymphoceles on computed tomography of the pelvis carried out 6 wk after surgery, the volume of the lymphoceles, and the degree of severe (Clavien-Dindo ≥3) complications. RESULTS AND LIMITATIONS: Of the 260 randomized patients, 245 were evaluated in the final analysis-123 in the intervention and 122 in the control group. The median follow-up was 595 d. There were no differences between the groups regarding clinical and pathological variables. The median of 17 nodes removed was the same in both groups (p = 0.961). Symptomatic lymphoceles occurred in 17 patients (6.9%), while in the intervention group these were found in three (2.4%) versus 14 (11.5%) in the control group (p = 0.011). The number of radiologically detected asymptomatic lymphoceles did not differ (p = 0.095). There was no significant difference in lymphocele volume between the two groups (p = 0.118). The rate of serious complications (Clavien 3a and 3b) was 4.8% in the intervention group and 9.1% in the control group (p = 0.587). A multivariate logistic regression model of symptomatic lymphocele occurrence was created with significant factors: body mass index (odds ratio [OR] = 1.1, 95% confidence interval [CI] = [1.03, 1.26], p = 0.012) and intervention (OR = 4.6, 95% CI = [1.28, 16.82], p = 0.02). CONCLUSIONS: Fixation of the peritoneum (PerFix) reduced the incidence of symptomatic lymphoceles in RARP with ePLND. We found no difference in the frequency of asymptomatic lymphocele development. The volume of the detected lymphoceles was similar. PATIENT SUMMARY: In this study, we compared the rate of development of postoperative complications using the peritoneal fixation technique with that of a nonfixation control group for robot-assisted radical prostatectomy with extended pelvic lymphadenectomy. Fixation of the peritoneum should obviate the development of severe complications in the postoperative period.

Use of adhesive cranial bone flap fixation without hardware to improve mechanical strength, resist cerebrospinal fluid leakage, and maintain anatomical alignment: a laboratory study.

OBJECTIVE: Titanium plates and screws (TPS) are the current standard of care for fixation of cranial bone flaps. These materials have been used for decades but have known potential complications, including flap migration, bone resorption/incomplete osseous union, hardware protrusion, cosmetic deformity, wound infection/dehiscence, and cerebrospinal fluid (CSF) leakage. This study evaluated the efficacy of a novel mineral-organic bone adhesive (Tetranite) for cranial bone flap fixation. METHODS: Craniotomy bone flaps created in human cadaveric skulls were tested under quasistatic and impact loading in the following conditions: 1) uncut skull; 2) bone flaps fixated with TPS alone; and 3) bone flaps fixated with bone adhesive alone. All fixative surgical procedures were performed by a group of 16 neurosurgeons in a simulated surgical environment. The position of adhesive-fixated cranial bone flaps was measured using computed tomography and compared with their original native location. The resistance of adhesive-fixated cranial bone flaps to simulated CSF leakage was also evaluated. Because there was a gap around the circumference of the TPS-fixated specimens that was visible to the naked eye, pressurized CSF leak testing was not attempted on them. RESULTS: Adhesive-fixated bone flaps showed significantly stiffer and stronger quasistatic responses than TPS-fixated specimens. The strength and stiffness of the adhesive-fixated specimens were not significantly different from those of the uncut native skulls. Total and plastic deflections under 6-J impact were significantly less for adhesive-fixed bone flaps than TPS. There were no significant differences in any subthreshold impact metrics between the adhesive-fixed and native specimens at both 6-J and 12-J impact levels, with 1 exception. Plastic deflection at 6-J impact was significantly less in adhesive-fixated bone flaps than in native specimens. The energy to failure of the adhesive-fixated specimens was not significantly different from that of the native specimens. Time since fixation (20 minutes vs 10 days) did not significantly affect the impact failure properties of the adhesive-fixated specimens. Of the 16 adhesive-fixated craniotomy specimens tested, 14 did not leak at pressures as high as 40 mm Hg. CONCLUSIONS: The neurosurgeons in this study had no prior exposure or experience with the bone adhesive. Despite this, improved resistance to CSF egress, superior mechanical properties, and better cosmetic outcomes were demonstrated with bone adhesive compared with TPS.

Flap Fixation as a Technique for Reducing Seroma Formation in Patients Undergoing Modified Radical Mastectomy: an Institutional Experience.

Formation of seroma most frequently occurs after mastectomy and axillary surgery. This study is intended at creating data on whether flap fixation has any role in reducing the seroma formation in patients undergoing the modified radical mastectomy. A prospective comparative study was conducted among 61 patients scheduled for modified radical mastectomy from 1st of January 2017 to 31st of December 2017. Patients were divided into two groups. In the flap fixation group (N = 30), the skin flaps were sutured to the pectoral muscle with Vicryl 3-0 sutures, and in the control group (N = 31), the wound was closed in the conventional methods at the edges. Closed suction drain was used in both groups. Flap fixation group showed a significantly lower frequency of seroma formation compared with the control group. In the flap fixation group, the drain was removed earlier compared with the control group. Mean value of the total amount of fluid drained for the study group was significantly lower than that of control. Flap fixation is a surgical technique which appears to reduce the total volume of fluid drained, the development of seroma, and the need for seroma aspirations.

Flap fixation in preventing seroma formation after mastectomy: an updated meta-analysis.

Seroma formation following mastectomy is one of the most experienced complications, with a very variable incidence ranging from 3 to 90%. In recent years, many publications have been realized to define an effective technique to prevent its formation and several approaches have been proposed. Given the potential of flap fixation in reducing seroma formation, we performed a meta-analysis of the literature to investigate the role of this approach as definitive gold standard in mastectomy surgery. Inclusion criteria regarded all studies reporting on breast cancer patients undergoing mastectomy with or without axillary lymph node dissection; studies that compared mastectomy with flap fixation to mastectomy without flap fixation were selected. Papers were eligible for inclusion if outcome was described in terms of seroma formation. As secondary outcome, also surgical site infection (SSI) was evaluated. The included studies were 12, involving 1887 female patients: 221/986 (22.41%) patients experienced seroma formation after flap fixation and 393/901 (43.61%) patients had this complication not receiving flap fixation, with a significant statistical difference between the two groups (OR = 0.267, p = 0.001, 95% CI 0.153, 0.464). About, SSI 59/686 (8.6%) in flap fixation group and 67/686 (9.7%) in patients without flap fixation, with no statistical differences between groups (OR = 0.59, p = 0.056, 95% CI 0.344, 1.013).The heterogeneity between included studies does not allow us to reach definitive conclusions but only to suggest the strong evaluation of this approach after mastectomy in seroma preventing and SSI reduction.

Cranial flap fixation in sheep using a resorbable bone adhesive.

OBJECTIVE: The authors' goal in this study was to investigate the use of a novel, bioresorbable, osteoconductive, wet-field mineral-organic bone adhesive composed of tetracalcium phosphate and phosphoserine (TTCP-PS) for cranial bone flap fixation and compare it with conventional low-profile titanium plates and self-drilling screws. METHODS: An ovine craniotomy surgical model was used to evaluate the safety and efficacy of TTCP-PS over 2 years. Bilateral cranial defects were created in 41 sheep and were replaced in their original position. The gaps (kerfs) were completely filled with TTCP-PS (T1 group), half-filled with TTCP-PS (T2 group), or left empty and the flaps fixated by plates and screws as a control (C group). At 12 weeks, 1 year, and 2 years following surgery, the extent of bone healing, local tissue effects, and remodeling of the TTCP-PS were analyzed using macroscopic observations and histopathological and histomorphometric analyses. Flap fixation strength was evaluated by biomechanical testing at 12 weeks and 1 year postoperatively. RESULTS: No adverse local tissue effects were observed in any group. At 12 weeks, the bone flap fixation strengths in test group 1 (1689 ± 574 N) and test group 2 (1611 ± 501 N) were both statistically greater (p = 0.01) than that in the control group (663 ± 385 N). From 12 weeks to 1 year, the bone flap fixation strengths increased significantly (p < 0.05) for all groups. At 1 year, the flap fixation strength in test group 1 (3240 ± 423 N) and test group 2 (3212 ± 662 N) were both statistically greater (p = 0.04 and p = 0.02, respectively) than that in the control group (2418 ± 1463 N); however, there was no statistically significant difference in the strengths when comparing the test groups at both timepoints. Test group 1 had the best overall performance based on histomorphometric evaluation and biomechanical testing. At 2 years postoperatively, the kerfs filled with TTCP-PS had histological evidence of osteoconduction and replacement of TTCP-PS by bone with nearly complete osteointegration. CONCLUSIONS: TTCP-PS was demonstrated to be safe and effective for cranial flap fixation in an ovine model. In this study, the bioresorbable, osteoconductive bone adhesive appeared to have multiple advantages over standard plate-and-screw bone flap fixation, including biomechanical superiority, more complete and faster bony healing across the flap kerfs without fibrosis, and the minimization of bone flap and/or hardware migration and loosening. These properties of TTCP-PS may improve human cranial bone flap fixation and cranioplasty.

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).

OBJECTIVE: The main objective of this double-blind randomized controlled trial (RCT) was to assess seroma formation and its sequelae in patients undergoing mastectomy. Patients were randomized into one of three groups in which different wound closure techniques were applied: 1) conventional wound closure without flap fixation (CON) 2) flap fixation using sutures (FF-S) and 3) flap fixation using an adhesive tissue glue (FF-G). BACKGROUND: Seroma formation is still a bothersome complication after mastectomy. Flap fixation seems promising in reducing seroma formation. Various flap fixation techniques remain to be analyzed, including long-term outcome measures. METHODS: This trial was conducted in three different hospitals between June 2014 and November 2016. Patients were allocated to one of three groups. The primary outcome was the number of seroma needle aspirations. Secondary outcomes were (surgical site) infections, number of outpatient clinic visits, shoulder function, postoperative pain, patient-reported cosmesis and skin dimpling. RESULTS: A total of 187 patients were randomly assigned to CON (n = 61), FF-S (n = 64) and FF-G (n = 62). The number of seroma aspirations was significantly higher in CON when compared to both flap fixation groups (p = 0.032), with no difference between FF-S and FF-G. Secondary outcomes showed no statistical differences between all groups. The higher number of outpatient clinic visits in CON was considered to be of clinical importance (CON = 27 (44.3%), FF-S = 19 (30.6%) and FF-G = 21 (34.4%)). CONCLUSIONS: Mastectomy followed by flap fixation with either sutures or adhesive tissue glue reduces the number of seroma aspirations when compared to simple wound closure.

Retrospective Chronologic Computed Tomography Analysis of Bone Flap Fusion and Resorption After Craniotomy and Autologous Cryopreserved Cranioplasty.

BACKGROUND: In open brain surgery, fixation of the bone flap is the final procedure. The bone flaps then fuse naturally. The objective of this study was to investigate the chronological process of bone fusion after craniotomy and autologous cranioplasty. METHODS: Retrospective data were collected from patients who underwent craniotomy or cranioplasty after August 2004 and had at least 1 computed tomography (CT) scan at 3 months postsurgery. The patients were divided into a craniotomy group and a cranioplasty group. Head CT scans were analyzed to evaluate bone fusion and resorption. RESULTS: Records from 978 patients who underwent craniotomy or cranioplasty between September 2004 and November 2015 were reviewed; 369 patients were eligible for the final analysis (craniotomy, n = 276; cranioplasty, n = 93). The mean cryopreservation period for the bone flap in the cranioplasty group was 49.3 days. The mean patient age was 51.4 ± 18.1 years in the craniotomy group and 51.6 ± 17.1 years in the cranioplasty group. Head CT scans showed bone fusion rates of 76.6% in the craniotomy group and 53.3% in the cranioplasty group at 6 months postsurgery (P = 0.015) and 78.6% and 78.1%, respectively, at 1 year postsurgery (P = 0.951). There was also a significant difference in the bone flap resorption rate between the 2 groups. CONCLUSIONS: Bone flap fusion rates after craniotomy and cranioplasty were significantly different before 12 months, but not significantly different thereafter. Bone resorption occurred more frequently in the cranioplasty group over time.

Impacts of pressure bonding fixation on a bone flap depression and resorption in patients with craniotomy.

Fixation of bone flaps after craniotomy is a routine part of every neurosurgical procedure. Common problems encountered are bone flap depression and resorption. Authors performed the pressure-bonding bone flap fixation (PBFF) using absorbable craniofix (AC) and hydroxyapatite wedge (HW). The aim of the present study is to evaluate the efficacy of PBFF to prevent a bone flap depression and resorption in patients treated with craniotomy. Four-hundred fifty-four patients underwent craniotomies. Authors collected the following data: age, sex, type of craniotomy, what kind of surgery, whether bypass surgery was performed, whether surgery was the initial, whether AC and the HW were used, bone flap depression and resorption at 6-month after the craniotomy. PBFF was defined as a bone flap fixation using both AC and HW to impress a bone flap to forehead. The mean age was 62±13years and 404 (89%) patients were women. PBFF was performed in 71 patients (16%), either AC or HW was used in 141 (31%), only AC was used in 116 (25%), and only HW was used in 25 (5.5%). At 6-month after the surgery, a bone flap depression was seen in 38 patients (8.4%), and a bone flap resorption was seen in 66 (15%). Multivariate analysis showed that only a PBBF showed a negative correlation with bone flap depression (p=0.044) and resorption (p=0.011). The results of the present study showed that PBFF reduced a bone flap depression and resorption and provided excellent postoperative cosmetic results.