Effect of Immediate Implant-Based Breast Reconstruction After Mastectomy With and Without Acellular Dermal Matrix Among Women With Breast Cancer: A Randomized Clinical Trial.

Importance: The use of acellular dermal matrix (ADM) in implant-based breast reconstructions (IBBRs) is established practice. Existing evidence validating ADMs proposed advantages, including improved cosmetics and more single-stage IBBRs, is lacking. Objective: To evaluate whether IBBR with ADM results in fewer reoperations and increased health-related quality of life (HRQoL) compared with conventional IBBR without ADM. Design, Setting, and Participants: This was an open-label, multicenter, randomized clinical trial of women with primary breast cancer who planned for mastectomy and immediate IBBR, with a 2-year follow-up for all participants. Participants were enrolled at 5 breast cancer units in Sweden and the United Kingdom between 2014 and May 2017. Exclusion criteria included previous radiotherapy and neo-adjuvant chemotherapy. Data were analyzed until August 2017. Interventions: Participants were allocated to immediate IBBR with or without ADM. Main Outcomes and Measures: The primary trial end point was number of reoperations at 2 years. HRQoL, a secondary end point, was measured as patient-reported outcome measures using 3 instruments from the European Organization for Research and Treatment of Cancer Quality of life Questionnaire. Results: From start of enrollment on April 24, 2014, to close of trial on May 10, 2017, a total of 135 women were enrolled (mean [SD] age, 50.4 [9.5] years); 64 were assigned to have an IBBR procedure with ADM and 65 to the control group who had IBBR without ADM. There was no statistically significant difference between groups for the primary outcome. Of 129 patients analyzed at 2-year follow-up, 44 of 64 (69%) had at least 1 surgical event in the ADM group vs 43 of 65 (66%) in the control group. In the ADM group, 31 patients (48%) had at least 1 reoperation on the ipsilateral side vs 35 (54%) in the control group. The overall number of reoperations on the ipsilateral side were 42 and 43 respectively. Within the follow-up time of 24 months, 9 patients (14%) in the ADM group had the implant removed compared with 7 (11%) in the control group. We found no significant mean differences in postoperative patient-reported HRQoL domains, including perception of body image (mean difference, 3; 99% CI, -11 to 17; P = .57) and satisfaction with cosmetic outcome (mean difference, 8; 99% CI, -6 to 20; P = .11). Conclusions and Relevance: Immediate IBBR with ADM did not yield fewer reoperations compared with conventional IBBR without ADM, nor was IBBR with ADM superior in terms of HRQoL or patient-reported cosmetic outcomes. Patients treated for breast cancer contemplating ADM-supported IBBR should be informed about the lack of evidence validating ADM's suggested benefits. Trial Registration: ClinicalTrials.gov Identifier: NCT02061527.

Ready-to-Use Micronized Human Acellular Dermal Matrix to Accelerate Wound Healing in Diabetic Foot Ulcers: A Prospective Randomized Pilot Study.

OBJECTIVE: To examine and report clinical outcomes of a ready-to-use micronized dermal matrix for diabetic foot ulcers (DFUs) and compare it to treatment with conventional negative-pressure wound therapy (NPWT) only. METHODS: The researchers randomly allocated 30 DFUs Wagner grade 2 or higher from 30 adult patients into two groups. The control group (n = 15) was treated with conventional NPWT, and the experimental group (n = 15) was treated with micronized dermal matrix and NPWT. The researchers evaluated the following outcomes: granulation tissue formation, proportion of patients with closed or granulated wounds at 42 and 120 days, achievement of complete wound healing in the 6 months of follow-up, and intervals from enrollment to final surgical procedures. RESULTS: All 15 wounds treated with the micronized matrix showed healthy granulation tissue without noticeable complications during follow-up. At 42 days, 46.7% of wounds in the experimental group had closed compared with 28.6% in the conventional NPWT group (P = .007). At 120 days, 86.7% of the experimental group had completely closed wounds, compared with 57.1% in the conventional therapy group (P = .040). During the 6-month follow-up period, 93.3% of the experimental group achieved complete wound healing compared with 85.7% of the conventional therapy group (P = .468). CONCLUSIONS: The healing outcomes for DFUs in the experimental group were superior when micronized matrix treatment was combined with NPWT.

Postirradiation Capsular Contracture in Implant-Based Breast Reconstruction: Management and Outcome.

BACKGROUND: Implant-based breast reconstruction is commonly avoided in the setting of radiation therapy, mainly because of risks of capsular contracture. Nevertheless, as breast reconstruction is becoming more available, more patients undergo both implant-based breast reconstruction and radiotherapy. The dilemma is how to manage capsular contracture if it does occur. The goal of this study was to examine the outcome of patients with implant-based breast reconstruction who developed postirradiation capsular contracture and were treated with capsulotomy or capsulectomy, with or without fat grafting. METHODS: The authors reviewed charts of patients who developed capsular contracture following alloplastic breast reconstruction followed by radiation therapy, between 2008 and 2018. The surgical treatment methods for capsular contracture were evaluated along with their outcomes. A follow-up of at least 1 year was required. RESULTS: Forty-eight breasts with postirradiation capsular contracture underwent surgical implant exchange with capsular release, of which 15 had combined fat grafting and 33 did not. Overall, 35 breasts (72.9 percent) showed long-term resolution of capsular contracture; 24 underwent a single procedure and 11 required an additional fat grafting procedure. Some patients [six breasts (12.5 percent)] were offered a consecutive round of fat grafting, and some [seven breasts (14.5 percent)] were offered autologous reconstruction because of lack of improvement. Fat grafting increased the success rate by more than 30 percent when it was initially and consecutively used. CONCLUSIONS: Postirradiation capsular contracture may be treated successfully by secondary procedures, sustaining implant-based breast reconstruction in over 70 percent of breasts. Fat grafting may elevate resolution rates even further, to 86 percent. Larger prospective studies are required to validate these findings. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Comparison of two perioperative antibiotic schedules in patients undergoing surgical reconstruction with dermal matrix after excision of skin cancer.

Perioperative antibiotic treatment duration in skin reconstruction with dermal substitutes is not well established. This study compares the incidence of infective complications after two different durations of perioperative antibiotic treatment in patients undergoing surgical reconstruction with skin dermal substitutes (SDS) after excision of skin cancer. Infective complications at the site of SDS were compared in subjects undergoing surgical reconstruction who received either a > 24-hour (extended protocol) or a ≤ 24-hour (short protocol) perioperative antibiotic treatment. Of 116 patients undergoing SDS surgical reconstruction, 62 (53.4%) received an extended schedule, and 54 (46.6%) received a short schedule. The two groups were similar for gender, age, comorbidities, American Society of Anesthesiologists score, and type of skin cancer. Overall incidence rate of infection was 20.7% (24/116). No differences in terms of risk of infection were observed between the two groups (OR: 1.04, 95% CI: 0.42-2.55; P = .937). Patients undergoing SDS reconstruction in the limb/foot had a higher risk of infection in comparison with those undergoing SDS reconstruction in the chest/head (OR: 2.69, 95% CI: 1.06-6.86; P = .038). The short protocol was demonstrated to be beneficial to patients undergoing surgical reconstruction with SDS. A ≤ 24-hour perioperative antibiotic schedule did not increase the infection rate, potentially allowing a reduction of antibiotic exposure.

Immediate Implant-Based Breast Reconstruction with Acellular Dermal Matrix: A Comparison of Sterile and Aseptic AlloDerm in 2039 Consecutive Cases.

BACKGROUND: Sterile ready-to-use acellular dermal matrix, introduced as an alternative to aseptic freeze-dried acellular dermal matrix for implant-based breast reconstruction, has been investigated in a limited number of studies. This study compared outcomes in implant-based breast reconstruction with ready-to-use and freeze-dried acellular dermal matrix. METHODS: The authors analyzed patients undergoing implant-based breast reconstruction with either freeze-dried or ready-to-use acellular dermal matrix, including demographics, clinical variables, and outcomes. An a priori power analysis was performed and logistic regression modeling was used to quantify the effect of acellular dermal matrix on outcomes while controlling for potential confounders. RESULTS: A total of 1285 consecutive patients undergoing 2039 immediate prosthetic breast reconstructions constituted the population: 612 (n = 910 breasts) with freeze-dried matrix and 673 (n = 1129 breasts) with ready-to-use acellular dermal matrix. The freeze-dried matrix cohort had a significantly higher rate of explantation compared with the ready-to-use matrix cohort (18.0 percent versus 12.0 percent; p = 0.0036), but surgical-site infection, wound dehiscence, mastectomy flap necrosis, seroma, and hematoma did not differ significantly between groups. On multivariate regression, patients undergoing reconstruction with freeze-dried matrix, compared to ready-to-use matrix, did not have higher odds of experiencing surgical-site infections (OR, 1.064; p = 0.7455), but did have higher odds of explantation (OR, 1.570; p = 0.0161). Tobacco use (OR, 2.809; p = 0.0002) and body mass index (OR, 1.054; p < 0.0001) were also independent predictors of explantation. CONCLUSION: Immediate implant-based breast reconstruction with sterile ready-to-use acellular dermal matrix has a comparable overall safety profile and a lower rate of prosthetic explantations compared with aseptic freeze-dried acellular dermal matrix. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Aseptic Freeze-Dried versus Sterile Wet-Packaged Human Cadaveric Acellular Dermal Matrix in Immediate Tissue Expander Breast Reconstruction: A Propensity Score Analysis.

BACKGROUND: Although multiple acellular dermal matrix sources exist, it is unclear how its processing impacts complication rates. The authors compared complications between two preparations of human cadaveric acellular dermal matrix (freeze dried and ready-to-use) in immediate tissue expander breast reconstruction to analyze the effect of processing on complications. METHODS: The authors retrospectively reviewed all alloplastic breast reconstructions with freeze-dried or ready-to-use human acellular dermal matrices between 2006 and 2016. The primary outcome measure was surgical-site occurrence defined as seroma, skin dehiscence, surgical-site infection, or reconstruction failure. The two groups were compared before and after propensity score matching. RESULTS: The authors included 988 reconstructions (freeze-dried, 53.8 percent; ready-to-use, 46.2 percent). Analysis of 384 propensity score-matched pairs demonstrated a slightly higher rate of surgical-site occurrence (21.4 percent versus 16.7 percent; p = 0.10) and surgical-site infection (9.6 percent versus 7.8 percent; p = 0.13) in the freeze-dried group than in the ready-to-use group, but the difference was not significant. However, failure was significantly higher for the freeze-dried versus ready-to-use group (7.8 percent versus 4.4 percent; p = 0.050). CONCLUSIONS: This is the largest study comparing the outcomes of alloplastic breast reconstruction using human acellular dermal matrix materials prepared by different methods. The authors demonstrated higher early complications with aseptic, freeze-dried matrix than with sterile ready-to-use matrix; reconstructive failure was the only outcome to achieve statistical significance. The authors conclude that acellular dermal matrix preparation has an independent impact on patient outcomes in their comparison of one company's product. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Trends in post-mastectomy breast reconstruction types at a breast cancer tertiary referral centre before and after introduction of acellular dermal matrices.

BACKGROUND: Reconstructive breast surgery has continued to evolve over the last decade with a key change being the adoption of acellular dermal matrices (ADMs) as an adjunct for implant-based procedures. This retrospective observational study assesses the effect of ADMs on post-mastectomy reconstructive practice performed in a single institution. METHODS: We conducted a review of all patients undergoing breast reconstruction at a University Teaching Hospital for an 18-month period before and after adopting ADMs. Demographic, procedural and complication data for these two cohorts were compared (χ2 and Student's t-tests). RESULTS: A total of 264 women (336 breasts), mean age 47.5 years, were identified: 137 before and 127 after the introduction of ADM. Implant-only reconstructions increased from 16% to 52% following the adoption of ADM (p < 0.01), whereas the proportion of both latissimus dorsi and deep inferior epigastric perforator flap reconstructions decreased significantly (31%-11% and 49%-34%, respectively, p < 0.01). The rate of early complications for the implant-only procedures was not significantly different with or without ADM (26% versus 20%, respectively, p = 0.44), despite there being no difference in the rate of adjuvant radiotherapy (22% versus 35%, respectively, p = 0.30). CONCLUSIONS: This study showed that since ADM introduction to our centre, more breast reconstructions have been of the implant-only type with consequent reductions in the more complex and expensive autologous techniques. Implant-only procedures that incorporated ADM use had similar complication rates to those that did not.

Rotator cuff tendon-to-bone healing at 12 months after patch grafting of acellular dermal matrix in an animal model.

There is no report to investigate the histology and biomechanical strength of remodeled tendon-to-bone junction more than 6 months after patch grafting with acellular dermal matrix (ADM) on rotator cuff defect. We investigated those 12 months after surgery and hypothesized that a new native enthesis is not regenerated and the biomechanical strength is inferior to normal control. Adult male Sprague-Dawley rats underwent ADM patch grafting for the rotator cuff defect. Quantitative histological analysis, immunohistochemical analysis for collagen type I and III, and biomechanical testing were performed 12 months after surgery. The controls were unoperated age-matched rats. In the grafted rats, the collagen arrangement was more irregular and the fibrocartilage layer was smaller at the tendon-bone interface than in the controls although dense collagen fibers in the remodeled tendon were observed; the number of chondrocytes, the percentage of chondrocytes aligned in rows, and the area of the fibrocartilage layer were significantly smaller than in the control group (p = 0.0252, 0.0039, and 0.0252, respectively). Grafted specimens showed significantly lower collagen organization in the midsubstance and tendon-bone interface than the controls (p = 0.0252 and 0.0374, respectively). Immunohistochemical analysis demonstrated that the remodeled tendon fibers were stained more strongly for type III than type I. At 12 months postoperatively, the ultimate load to failure was significantly lower in the graft group than normal control (p = 0.0026); that was 47.8% of normal controls. 12 months after rotator cuff patch grafting with ADM, the formation of a new enthesis grossly resembled the native structure but there was poor cellular organization and the biomechanical strength of remodeled tendon-to-bone was only 48% of normal controls. Advances in tissue engineering and postoperative rehabilitation are needed to promote the healing process after rotator cuff patch grafting.

Reverse Sural Adipofascial Flaps with Acellular Dermal Matrix and Negative-Pressure Wound Therapy.

The reverse sural adipofascial flap (RSAF) is used to reconstruct challenging wounds of the foot and ankle. It offers several advantages over the traditional reverse sural flap, including less venous congestion. To complete the reconstruction, split-thickness skin grafting (STSG) may be done immediately or in a delayed fashion; however, both scenarios result in suboptimal take rates and prolonged healing. An acellular dermal matrix (ADM; Integra; Ethicon Inc, Somerville, New Jersey) and negative-pressure wound therapy (NPWT) combined with RSAF followed by delayed STSG may decrease wound healing time.In this study, 8 patients underwent reconstruction of lower-extremity wounds with RSAF. Four patients underwent RSAF with immediate STSG, and 4 underwent RSAF with placement of the ADM and a vacuum-assisted closure device, with STSG at a later date.The 4 patients who underwent RSAF and immediate STSG had an average time to heal of 141.2 days, and 2 patients required reoperation. The 4 patients who underwent RSAF with an ADM and NPWT had an average time to heal of 104.5 days, and 1 patient required reoperation. Average time until STSG was 41.5 days. The latter group demonstrated a reduction in time to heal by an average of 36.7 days, or 25%. All 8 patients achieved successful wound closure.The RSAF is a durable option for complex lower-extremity reconstruction. Interim placement of ADM and NPWT may increase STSG take rates. Using this technique in conjunction with RSAF may decrease the overall healing time compared with RSAF with immediate STSG.

Application of Human Acellular Breast Dermal Matrix (ABDM) in Implant-Based Breast Reconstruction: An Experimental Study.

BACKGROUND: The use of acellular dermal matrices (ABDM) has become more common for breast reconstruction to improve postoperative outcomes. We evaluated the efficacy of breast reconstruction by the application of human ABDM in a sheep model. METHODS: The sheep in group I (GI) (N = 4) underwent the following procedures on the right side: (1) breast reconstruction using human ABDM after total mastectomy, (2) human ABDM under the skin, near the breast area and on the left side, (3) fat injection and human ABDM after partial mastectomy, and (4) replacement of ABDM in the abdominal wall far from the breast. Sheep in group II (GII) (N = 4) underwent the following procedures. On the right side: (1) breast reconstruction using ABDM after total mastectomy, (2) replacement of ABDM under the skin, near the breast area, and on the left side, (3) application of vicryl synthetic mesh after partial mastectomy and (4) replacement of mesh under the skin, near the breast area. RESULTS: Histological evaluations of decellularized skin scaffolds demonstrated a collagen-based matrix with preserved ECM and complete nuclear removal. Histological evaluations of implanted ABDM demonstrated a viable matrix with fibroblast infiltration and revascularization in all follow-ups. The overall surgical complication rate was significantly lower in the ABDM implant under the skin and near the breast in both short- and long-term follow-ups. CONCLUSION: The results of this study demonstrated that the application of novel prepared ABDMs has promising outcomes for breast reconstruction to provide total coverage without the need for breast expansion before implant placement. NO LEVEL ASSIGNED: 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 http://www.springer.com/00266.

Effect of Drain Placement on Infection, Seroma, and Return to Operating Room in Expander-Based Breast Reconstruction.

INTRODUCTION: There is significant variability in the location and management of drains in breast reconstruction, with most surgeons attempting to shorten the duration of drains while preventing complications possibly related to early removal. The aim of this work was to compare our experiences with placement of 1 versus 2 drains in tissue expander breast reconstruction. METHODS: This is a retrospective cohort study comparing 2 groups of patients after breast tissue expander placement in a complete submuscular pocket and without the use of acellular dermal matrix. In the first group, a single subcutaneous drain was placed; in the second group, both a subcutaneous and a submuscular drain were placed. These groups were evaluated on their relative duration of drain placement, incidence of seroma formation, incidence of infection, and rates of complication necessitating return to operating room (OR). RESULTS: The single-drain group was found to have a significantly shorter duration of drain placement (14.58 vs 22.84 days, P = < 0.01) as well as lower incidence of return to OR for complications after expander placement (8.3% vs 17.6%, P = 0.040), with no difference in rate of seroma formation (6.9% vs 14.7%, P = 0.114) or infection (1.4% in the single-drain group vs 8.8% in the 2-drain group, P = 0.054). CONCLUSIONS: Compared with a two-drain approach, a single subcutaneous drain yields shorter total duration of drain placement and lower rate of complications requiring return to OR while not resulting in higher rates of seroma or infection. It has become our standard approach to use a single subcutaneous drain in patients having a breast tissue expander placed in a submuscular pocket.

Clinical Outcomes in Breast Reconstruction Patients Using a Sterile Acellular Dermal Matrix Allograft.

BACKGROUND: Human acellular dermal matrices (ADMs) have enabled successful breast reconstructions while decreasing muscle donor morbidity and pain for the patient. However, some literature reports indicate an increase in complications, especially infection. The decellularization and terminal sterilization properties of DermACELL (D-ADM), a human ADM, may reduce the rate of complications in augmented breast reconstruction while still maintaining successful outcomes. In the study presented here, we evaluate the quality and safety of outcomes with the use of D-ADM during tissue expander breast reconstruction. METHODS: A retrospective chart review was conducted of patients who underwent breast reconstruction with the use of D-ADM, at a single-military hospital-based practice, resulting in a population of 38 subjects and 58 breasts who had breast reconstruction augmented with D-ADM. RESULTS: Fifty-six breasts (96.6%) in thirty-six patients demonstrated successful outcomes with a median 27 weeks' time to complete healing. Post-reconstruction radiation and chemotherapy were applied to 24.1 and 25.9% of reconstructions, respectively. Complications rates were minimal with rates of 1.7% for surgical site infection and 1.7% for red breast syndrome. CONCLUSION: The low complication rates combined with the high success and patient satisfaction rates observed for D-ADM support the use of this ADM in breast reconstruction. LEVEL OF EVIDENCE IV: 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 .

Primary fascial closure with biologic mesh reinforcement results in lesser complication and recurrence rates than bridged biologic mesh repair for abdominal wall reconstruction: A propensity score analysis.

BACKGROUND: Previous studies suggest that bridged mesh repair for abdominal wall reconstruction may result in worse outcomes than mesh-reinforced, primary fascial closure, particularly when acellular dermal matrix is used. We compared our outcomes of bridged versus reinforced repair using ADM in abdominal wall reconstruction procedures. METHODS: This retrospective study included 535 consecutive patients at our cancer center who underwent abdominal wall reconstruction either for an incisional hernia or for abdominal wall defects left after excision of malignancies involving the abdominal wall with underlay mesh. A total of 484 (90%) patients underwent mesh-reinforced abdominal wall reconstruction and 51 (10%) underwent bridged repair abdominal wall reconstruction. Acellular dermal matrix was used, respectively, in 98% of bridged and 96% of reinforced repairs. We compared outcomes between these 2 groups using propensity score analysis for risk-adjustment in multivariate analysis and for 1-to-1 matching. RESULTS: Bridged repairs had a greater hernia recurrence rate (33.3% vs 6.2%, P < .001), a greater overall complication rate (59% vs 30%, P = .001), and worse freedom from hernia recurrence (log-rank P <.001) than reinforced repairs. Bridged repairs also had a greater rate of wound dehiscence (26% vs 14%, P = .034) and mesh exposure (10% vs 1%, P = .003) than mesh-reinforced abdominal wall reconstruction. When the treatment method was adjusted for propensity score in the propensity-score-matched pairs (n = 100), we found that the rates of hernia recurrence (32% vs 6%, P = .002), overall complications (32% vs 6%, P = .002), and freedom from hernia recurrence (68% vs 32%, P = .001) rates were worse after bridged repair. We did not observe differences in wound healing and mesh complications between the 2 groups. CONCLUSION: In our population of primarily cancer patients at MD Anderson Cancer Center bridged repair for abdominal wall reconstruction is associated with worse outcomes than mesh-reinforced abdominal wall reconstruction. Particularly when employing acellular dermal matrix, reinforced repairs should be used for abdominal wall reconstruction whenever possible.

A single-arm trial indirect comparison investigation: a proof-of-concept method to predict venous leg ulcer healing time for a new acellular synthetic matrix matched to standard care control.

To compare data on time to healing from two separate cohorts: one treated with a new acellular synthetic matrix plus standard care (SC) and one matched from four large UK pragmatic, randomised controlled trials [venous leg ulcer (VLU) evidence network]. We introduce a new proof-of-concept strategy to a VLU clinical evidence network, propensity score matching and sensitivity analysis to predict the feasibility of the new acellular synthetic matrix plus SC for success in future randomised, controlled clinical trials. Prospective data on chronic VLUs from a safety and effectiveness study on an acellular synthetic matrix conducted in one wound centre in the UK (17 patients) and three wound centres in Australia (36 patients) were compared retrospectively to propensity score-matched data from patients with comparable leg ulcer disease aetiology, age, baseline ulcer area, ulcer duration, multi-layer compression bandaging and majority of care completed in specialist wound centres (average of 1 visit per week), with the outcome measures at comparable follow-up periods from patients enrolled in four prospective, multicentre, pragmatic, randomised studies of venous ulcers in the UK (the comparison group; VLU evidence network). Analysis using Kaplan-Meier survival curves showed a mean healing time of 73·1 days for ASM plus SC (ASM) treated ulcers in comparison with 83·5 days for comparison group ulcers treated with SC alone (Log rank test, χ2 5·779, P = 0·016) within 12 weeks. Sensitivity analysis indicates that an unobserved covariate would have to change the odds of healing for SC by a factor of 1·1 to impact the baseline results. Results from this study predict a significant effect on healing time when using a new ASM as an adjunct to SC in the treatment of non-healing venous ulcers in the UK, but results are sensitive to unobserved covariates that may be important in healing time comparison.

Two-stage implant-based breast reconstruction compared with immediate one-stage implant-based breast reconstruction augmented with an acellular dermal matrix: an open-label, phase 4, multicentre, randomised, controlled trial.

BACKGROUND: The evidence justifying the use of acellular dermal matrices (ADMs) in implant-based breast reconstruction (IBBR) is limited. We did a prospective randomised trial to compare the safety of IBBR with an ADM immediately after mastectomy with that of two-stage IBBR. METHODS: We did an open-label, randomised, controlled trial in eight hospitals in the Netherlands. Eligible women were older than 18 years with breast carcinoma or a gene mutation linked with breast cancer who intended to undergo skin-sparing mastectomy and immediate IBBR. Randomisation was done electronically, stratified per centre and in blocks of ten to achieve roughly balanced groups. Women were assigned to undergo one-stage IBBR with ADM (Strattice, LifeCell, Branchburg, NJ, USA) or two-stage IBBR. The primary endpoint was quality of life and safety was assessed by the occurrence of adverse outcomes. Analyses were done per protocol with logistic regression and generalised estimating equations. This study is registered at Nederlands Trial Register, number NTR5446. FINDINGS: 142 women were enrolled between April 14, 2013, and May 29, 2015, of whom 59 (91 breasts) in the one-stage IBBR with ADM group and 62 (92 breasts) in the two-stage IBBR group were included in analyses. One-stage IBBR with ADM was associated with significantly higher risk per breast of surgical complications (crude odds ratio 3·81, 95% CI 2·67-5·43, p<0·001), reoperation (3·38, 2·10-5·45, p<0·001), and removal of implant, ADM, or both (8·80, 8·24-9·40, p<0·001) than two-stage IBBR. Severe (grade 3) adverse events occurred in 26 (29%) of 91 breasts in the one-stage IBBR with ADM group and in five (5%) of 92 in the two-stage IBBR group. The frequency of mild to moderate adverse events was similar in the two groups. INTERPRETATION: Immediate one-stage IBBR with ADM was associated with adverse events and should be considered very carefully. Understanding of selection of patients, risk factors, and surgical and postsurgical procedures needs to be improved. FUNDING: Pink Ribbon, Nuts-Ohra, and LifeCell.

[Application of combination of xenoskin with delayed microskin graft in extensively burned patients].

OBJECTIVE: To observe clinical effects of combination of acellular porcine skin with delayed microskin graft on extensively burned patients.
 Methods: Forty extensively burned patients were assigned into a treatment group and a control group. In the treatment group, 20 patients were covered with acellular porcine skin after escharectomy, and the delayed microskin grafting was performed 5 days later. In the control group, 20 patients were covered with allograft skin combined with microskin graft after escharectomy. The cure rate, the graft survival rate, wound healing time and cost per 1% wound were observed.
 Results: The cure rate for the 2 groups was the same (90%), and wound healing time was similar between the two groups (P>0.05). The graft survival rate in the treatment group was higher than that in the control group (P<0.05), and cost per 1% wound in the treatment group was less than that in the control group (P<0.05).
 Conclusion: The combination of acellular porcine skin with delayed microskin graft is an effective method to treat extensively burned patients, and it provides an ideal substitute for allograft skin combined with microskin graft.

Mesh versus acellular dermal matrix in immediate implant-based breast reconstruction - A prospective randomized trial.

BACKGROUND: Comparative studies on the use of meshes and acellular dermal matrices (ADM) in implant-based breast reconstruction (IBBR) have not yet been performed. METHODS: This prospective, randomized, controlled, multicenter pilot study was performed at four Austrian breast cancer centers. Fifty patients with oncologic or prophylactic indication for mastectomy and IBBR were randomized to immediate IBBR with either an ADM (Protexa(®)) or a titanized mesh (TiLOOP(®) Bra). Complications, failed reconstruction, cosmetic outcome, patients' quality of life and the thickness of the overlying tissue were recorded immediately postoperatively and 3 and 6 months after surgery. RESULTS: 48 patients participated in the study (Protexa(®) group: 23; TiLOOP(®) Bra group: 25 patients). The overall complication rate was 31.25% with similar rates in both groups (Protexa(®) group: 9 versus TiLOOP(®) Bra group: 6; p = 0.188). There was a higher incidence of severe complications leading to failed reconstructions with implant loss in the Protexa(®) group than in the TiLOOP(®) Bra group (7 versus 2; p < 0.0001). An inverted T-incision technique led to significantly more complications and reconstructive failure with Protexa(®) (p = 0.037, p = 0.012, respectively). There were no significant differences in patients' satisfaction with cosmetic results (p = 0.632), but surgeons and external specialists graded significantly better outcomes with TiLOOP(®) Bra (p = 0.034, p = 0.032). CONCLUSION: This pilot study showed use of TiLOOP(®) Bra or Protexa(®) in IBBR is feasible leading to good cosmetic outcomes and high patient satisfaction. To validate the higher failure rates in the Protexa(®) group, data from a larger trial are required. NCT02562170.

Use of fenestrations in acellular dermal allograft in two-stage tissue expander/implant breast reconstruction.

UNLABELLED: The authors present a new technique of alteration of the acellular dermal matrix through strategically placed fenestrations, improving the reconstructive experience and overall cosmetic outcome. The authors present a retrospective chart review following two surgeons' experience at the University of California, Irvine, Department of Plastic Surgery using surgeon-designed fenestrated acellular dermal matrices in two-stage tissue expander breast reconstruction. The authors found that this leads to improved intraoperative fill volume, decreased number of postoperative expansions, increased expansion rate with subjectively less pain, decreased time to full expansion, and subjectively improved cosmetic outcome. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Acellular dermal matrix for reoperative breast augmentation.

Revisionary breast surgery in previously augmented patients is complex, with many variables that have to be considered. Obtaining durable repairs is challenging because these patients often present with thinned breast tissue, inadequate local tissue, and/or scarred breast envelope from multiple procedures. Capsular contracture, ptosis, tissue atrophy, and wrinkling/rippling are some of the most frequent reasons for reoperation. Conventional repair techniques generally involve a combination of capsule modification (capsular flaps), site change, mastopexy, and implant exchange. Recently, acellular dermal matrices have been introduced into revision surgery to reinforce soft tissue, reinforce the implant pocket, and potentially mitigate capsular contracture. Clinical outcomes of acellular dermal matrix-assisted revision surgery are reviewed from the published literature to evaluate the efficacy and safety of acellular dermal matrices for this indication.