Acellular Dermal Matrix Products Research Articles

Single versus Double Drainage for Immediate Two-Stage Implant-Based Breast Reconstruction: A Propensity Score-Matched Analysis.

Reports evaluating plastic surgeons' practices indicate there are conflicting trends regarding the use of one or two drains for implant-based breast reconstruction (IBBR). Our study aimed to perform a matched cohort analysis to examine the postoperative outcomes and complications of immediate IBBR with tissue expander (TE) using two drains versus a single drain. A propensity score-matched analysis (nearest neighbor, 1:1 matching) of immediate reconstructions using two versus one drain was conducted. Female patients undergoing immediate two-stage IBBR with TEs between January 2011 and May 2021 were included. The covariables were as follows: BMI, mastectomy weight, lymph node surgery, TE surface, plane of reconstruction, use of acellular dermal matrix products, fluorescence imaging use, and intraoperative TE volume. After matching using propensity scores, 192 reconstructions were included in the final analysis: 96 in each group. The rate of 30-day complications and overall complications during the first phase of IBBR were comparable between groups. The time for drain removal, time to initiate and finalize expansions, and time for TE-to-implant exchange were comparable between groups. Diabetes (OR 3.74, p = 0.025) and an increased estimated blood loss (OR 1.004, p = 0.01) were the only independent predictors for seroma formation. In this matched cohort analysis evaluating the role of one versus two drains for two-stage IBBR, we found a comparable rate of complications and surgical outcomes between the two cohorts. Using two drains for immediate IBBR needs to be tailored depending on intraoperative findings. 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 .

A comparison of clinical outcomes of acellular dermal matrix with and without radiation sterilization process in immediate prepectoral direct-to-implant breast reconstruction

Although there are many acellular dermal matrix (ADM) products, the sterilization process varies for each product. We compared the clinical outcomes of immediate prepectoral direct-to-implant (DTI) breast reconstruction with and without sterilization products. This was a retrospective study of immediate prepectoral DTI breast reconstructions performed between 2018 and 2020. We classified patients depending on whether the used ADM products had undergone radiation sterilization and compared the patient demographics and surgical outcomes, including seroma, infection, mastectomy flap necrosis, capsular contracture, and implant failure. The study included 357 patients, 182 in the no-sterilization group and 179 in the sterilization group. The ADM size differed significantly between the no-sterilization and sterilization groups (122.7cm2 vs. 145.4cm2, respectively, P=0.01). There were no significant differences in overall rates of complications between the two groups, including seroma (P=0.28), infection (P=0.63), mastectomy flap necrosis (P=0.76), and capsular contracture (P=0.76). However, implant failure from infection (0% vs. 3.4%, P=0.01) and drainage amount (690.3mL vs. 779.36mL, P=0.04) with similar removal days were significantly higher in the sterilization group. The authors demonstrated similar complication rates for seroma, infection, mastectomy flap necrosis, and capsular contracture. Whereas a bigger size of ADM was needed to cover a similar implant volume, and drain amount was higher in the sterilization group, the salvage rate from infection was higher in the no-sterilization group with a significant difference.

Fish Skin Graft: Narrative Review and First Application for Abdominal Wall Dehiscence in Children.

Acellular fish skin grafts (FSGs) are tissue-based products created by minimally processing the skin of the Atlantic cod (Gadus morhua). The FSG is rich in omega-3 and facilitates tissue regeneration by supporting revascularization and ingrowth in the proliferation and remodeling phases of wound healing. FSG is structurally more similar to human skin than antiviral-processed skin substitutes such as amniotic membrane, and there are no known prion, bacterial, or viral diseases that can be transmitted from North-Atlantic cod to humans. The FSG is processed using a proprietary method that preserves the structure and lipid composition of the skin. FSG is CE marked, and US Food and Drug Administration cleared for multiple clinical applications in partial and full-thickness wounds. FSG is currently the only acellular dermal matrix product that does not originate from mammalian tissues. For this narrative review, Medline and UpToDate were used to include a total of 21 articles published from 2015 to 2022 about fish skin graft use. We also reported a case of a 7-year-old boy who underwent treatment with FSG for abdominal wall dehiscence at our department of pediatric surgery, IRCCS Sant'Orsola-Malpighi, Alma Mater Studiorum, University of Bologna, University Hospital of Bologna. FSG provides a valuable and sustainable treatment that improves wound healing in both adult and pediatric populations. We described the first application of an FSG for wound dehiscence of the abdominal wall in a pediatric patient, reporting how FSG was completely reabsorbed and improved the skin's repair.

Acellular dermal matrix for one-stage treatment of lower extremity full-thickness skin defect: a case series

BackgroundSelf-repair of lower limb wounds has always been one of the research hotspots. Flaps and skin graft are the preferred treatment for lower extremity wound reconstruction. However, these treatments have many disadvantages, such as secondary damage, poor healing quality. In recent years, the use of acellular dermal matrix has emerged as an alternative treatment option for extremity ulcers.MethodsThis study aimed to explore whether acellular dermal matrix can be used as a single treatment to promote wound healing. 7 patients with lower extremities cutaneous deficiency exposing bone or tendon, were covered by Pelnac, which was an acellular dermal matrix product approved by China Food and Drug Administration. All the wound was treated by Pelnac without flaps and skin graft. The external dressing was changed every 10 days.ResultsAfter a maximum of 20 weeks, all the wounds were completely healed. During the 12 months follow-up period none of the patients developed skin wear on the treatment area. All patients maintained their postoperative ambulatory ability. All patients were satisfied with the appearance and feeling after wound healing.ConclusionThese findings may mean acellular dermal matrix is a novel method offering opportunity for treatment of lower extremities cutaneous deficiency exposing bone or tendon. It also has the potential to close wounds of all uninfected, non-ischemic, full-thickness cutaneous deficiency.

Effective decellularization of human skin tissue for regenerative medicine by supercritical carbon dioxide technique.

Allotransplantation, performed using an acellular dermal matrix (ADM), plays a significant role in the cultivation of constituted and damaged organs in clinical. Herein, we fabricated an innovative ADM for allografting derived from decellularized human skin by utilizing the supercritical fluid of carbon dioxide to eliminate immunogenic components. By using histological staining, the ADM product demonstrated the successful removal of cellular constituents without exerting any harmful influence on the extracellular matrix. The results from DNA electrophoresis also supported this phenomenon by showing the complete DNA removal in the product, accompanied by the absence of Major Histocompatibility Complex 1, which suggested the supercritical fluid is an effective method for cellular withdrawal. Moreover, the mechanical property of the ADM products, which showed similarity to that of native skin, displayed great compatibility for using our human-derived ADM as an allograft in clinical treatment. Specifically, the cell viability demonstrated the remarkable biocompatibility of the product to human bio-cellular environment which was noticeably higher than that of other products. Additionally, the significant increase in the level of growth factors such as vascular endothelial growth factor, urokinase-type plasminogen activator receptor, granulocyte-macrophage colony-stimulating factor suggested the ability to stimulate cellular processes, proving the products to be innovative in the field of regeneration when applied to clinical in the future. This study provides a thoroughly extensive analysis of the new ADM products, enabling them to be applied in industrial and clinical treatment.

Direct comparison of CGCRYODERM and DermACELL in the same patient for outcomes in bilateral implant-based breast reconstruction: a retrospective case series.

The use of acellular dermal matrix (ADM) has been popularized in implant-based breast reconstruction (IBR). However, it is still controversial if ADM-associated complication rates differ with varying types of ADM products. The aim of this study was to compare postoperative complications between CGCRYODERM and DermACELL. A retrospective chart review was performed on 32 patients (64 breasts) who underwent bilateral prosthetic breast reconstruction between June 2015 and December 2019. All patients received two different ADMs in each breast during the surgery. Demographic variables, operative characteristics, and postoperative outcomes were compared between the cryopreserved and pre-hydrated ADM. The overall major and minor postoperative complications developed in 7 and 1 out of 32 patients, respectively. Seroma and infection were the most common complications. There were no cases that infection and/or seroma involved both breasts in one individual. No significant differences were observed in terms of seroma, infection, hematoma, mastectomy flap necrosis, or drainage period between the CGCRYODERM and DermACELL groups (P=0.5637, 0.1797, 1.0000, 0.3173, and 0.2925, respectively). There was no case of reconstruction failure leading to explantation. There were no statistically significant differences in postoperative complications between the two breasts reconstructed with CGCRYODERM and DermACELL in the same patient who underwent bilateral IBR. This is the first study to compare cryopreserved and pre-hydrated ADMs. We suggest that CGCRYODERM is a suitable option with a comparable safety profile for IBR.

Short-term changes of human acellular dermal matrix (Megaderm) in a mouse model.

BackgroundPhysicians tend to overcorrect when applying the acellular dermal matrix for reconstructive option because of volume decrement problem after absorption comparing with initial volume. However, there are no studies on the exact volume decrement and absorption rate with commercial products in South Korea. To figure out absorption rate of acellular dermal matrix product in South Korea (Megaderm), authors designed this experiment.MethodsNine mice were used and randomly divided into three groups by the time with sacrificing. The implant (Megaderm) was tailored to fit a cuboid form (1.0 cm× 1.0 cm in length and width and 2.0 mm in thickness). A skin incision was made at anterior chest with blade #15 scalpel with exposing the pectoralis major muscle. As hydrated Megaderm was located upon the pectoralis major muscle, the skin was sutured with Ethilon #5-0. After the surgical procedure, each animal group was sacrificed at 4, 8, and 12 weeks, respectively, for biopsies and histological analysis of the implants. All samples were stained with routine hematoxylin and eosin staining and Masson’s trichrome staining and the thickness were measured. A measurements were analyzed using Friedman test. Statistically, the correlation between thicknesses of Megaderm before and after implantation was analyzed.ResultsAfter sacrificing the animal groups at postoperative 4, 8, 12 weeks, the mean tissue thickness values were 2.10± 1.03 mm, 2.17± 0.21 mm, and 2.40± 0.20 mm (p= 0.368), respectively. The remaining ratios after absorption comparing with after initial hydrated Megaderm were 82.7%, 85.4%, and 94.5%, respectively. In histopathological findings, neovascularization and density of collagenous fiber was increased with time.ConclusionAuthor’s hypothesis was absorption rate of implant would be increased over time. But in this experiment, there is no statistical significance between mean absorption thickness of implant and the time (p= 0.368). Also it can be affected by graft site, blood supply, and animals that were used in the experiment.

Repair of Primary Cleft Palate and Oronasal Fistula With Acellular Dermal Matrix: A Systematic Review and Surgeon Survey

The current review and survey aim to assess the effectiveness of acellular dermal matrix (ADM) in the repair of cleft palate and oronasal fistula and to evaluate the current trends of ADM use in palate surgery. A systematic review of English articles was conducted using MEDLINE (1960 to July 1, 2016), the Cochrane Controlled Trials Register (1960 to July 1, 2016), and EMBASE (1991 to July 1, 2016). Additional studies were identified through a review of references cited in initially identified articles. Search terms included "cleft palate," "palatal," "oronasal fistula," "acellular dermal matrix," and "Alloderm®." An online survey was disseminated to members of the American Cleft Palate-Craniofacial Association to assess current trends in ADM use in palate surgery. All studies evaluating the outcome of primary palate repair or repair of oronasal fistula with the use of aceullar dermal matrix products were included in the review. Twelve studies met inclusion criteria for review. Studies were generally of low quality, as indicated by methodological index for non-randomized studies (MINORS) scores ranging from 7 to 14. The pooled estimate for fistula formation after primary palatoplasty following ADM use was 7.1%. The pooled estimate for recurrence of fistula after attempted repair using ADM was 11%. Thirty-six cleft surgeons responded to the online survey study. Of these, 45% used ADM in primary cleft palate repair, while 67% used ADM for repair of oronasal fistulae. Use of ADM products is commonplace in palate surgery. Despite this, there is a paucity of high-quality data demonstrating benefit. Further randomized controlled trials examining ADM in palate surgery are required to help develop structured guidelines and improve care.

A Histological Comparison of Two Human Acellular Dermal Matrix Products in Prosthetic-Based Breast Reconstruction.

Background:Acellular dermal matrices (ADMs) are an integral component of breast reconstruction. The ideal matrix would be relatively immuno-inert, allow rapid vascularization, and be affordable. The purpose of this study was to histologically compare 2 commonly used ADM products.Methods:This is a prospective histological study of 17 patients (20 breasts) following prosthetic-based breast reconstruction with ADM: Alloderm (LifeCell Corp, Branchburg, N.J.) or Cortiva (RTI Surgical, Alachua Fla.). Biopsies were taken from the dermal matrix and natural capsules surrounding the expander/implant during secondary surgery [Range, 72—694 days (mean, 217 days)]. Biopsy specimens were prepared via hematoxylin and eosin, Masson's trichrome, elastin, and transforming growth factor (TGF)-1 stains. Quantitative analysis of staining was performed with ImageJ software. The clinical outcome of each patient is analyzed in relation to capsule architecture and ADM performance.Results:There were 7 breasts in the Alloderm group and 13 in the Cortiva group. Both groups had similar demographic, aesthetic results, and complication profiles. The TGF-1 staining demonstrated significantly lower levels in the Cortiva capsules (P = 0.0139). The percentage of elastin and collagen are similar in the Cortiva, Alloderm, and natural peri-implant capsules. The native capsules show a significantly greater number of blood vessels when compared with Cortiva and Alloderm (P = 0.0371 and P = 0.0347, respectively); however, there is no difference in vascular pattern between the 2 dermal matrices.Discussion:Postoperatively, Cortiva demonstrates equal vascularity with less TGF-1 activation compared with Alloderm. The clinical success and complication profile were similar between the Alloderm and Cortiva patients.

Reconstruction of Congenital Sternal Clefts: Surgical Experience and Literature Review.

Background:Sternal cleft is a rare anomaly with a reported incidence of 1:100,000 cases per live births. Surgical intervention represents a crucial factor altering the overall patient prognosis, since they are at high risk of impaired oxygenation, as well as multiple chest infections. Herein, we are reporting our experience of surgical management of such rare cases, alerting plastic surgeons to their possibly crucial role in the reconstructive team.Methods:A retrospective chart review of 2 cases presenting with chest wall defects. All perioperative data were collected and presented.Results:Two patients with sternal clefts of variable degrees were managed. The first was an 18-month-old boy with partial inferior sternal cleft, who was otherwise asymptomatic. The patient underwent reconstruction at the same age using autologous rib graft and pectoralis major flaps due to ectopia cordis that was putting the patient at higher risk for cardiac trauma. The second patient was a 3-month-old girl having a V-shaped partial superior cleft with lung herniation. Surgical reconstruction was applied due to difficulty in weaning the patient off of ventilator support. Initially, reconstruction was applied with SurgiMend dermal matrix, but this was complicated by chest retraction and high oxygen requirement. Definitive reconstruction was later applied with allogeneic bone graft and pectoralis major flaps.Conclusions:Meticulous patient assessment and screening for associated anomalies are crucial. Surgical intervention is warranted at an early age. The use of acellular dermal matrix products in the reconstruction is of interest, but should be approached with caution.

Effect of transcranial direct current stimulation on motor control during reaching movement in a child with down syndrome – Case report

Use of human acellular dermal matrix (ADM) during prosthetic breast reconstruction has increased. Several ADM products are available produced by differing manufacturing techniques. It is not known if outcomes vary with different products. This study reports the complication prevalence following use of a tutoplast-derived ADM (T-ADM) in prosthetic breast reconstruction. We performed a retrospective chart review of 203 patients (mean follow-up times 12.2 months) who underwent mastectomy and immediate prosthetic breast reconstruction utilizing T-ADM, recording demographic data, surgical indications and complication (infection, seroma, hematoma, wound healing exceeding three weeks and reconstruction failure). During a four-year period, 348 breast reconstructions were performed Complications occurred in 16.4% of reconstructed breasts. Infection occurred in 6.6% of breast reconstructions (3.7% – major infection, requiring intravenous antibiotics and 2.9% minor infection, requiring oral antibiotics only). Seromas occurred in 3.4% and reconstruction failure occurred in 0.6% of breast reconstructions. Analysis suggested that complication prevalence was significantly higher in patients with a BMI >30 (p = 0.03). The complication profile following T-ADM use is this series is comparable to that reported for with other ADM products. T-ADM appears to be a safe and acceptable option for use in ADM-assisted breast reconstruction.

P153. Use of acellular dermal matrix (ADM) in nipple reconstruction following breast reconstruction; the ‘central-pillar technique’

P153. Use of acellular dermal matrix (ADM) in nipple reconstruction following breast reconstruction; the ‘central-pillar technique’

P152. Is lipomodelling after breast cancer safe?

P152. Is lipomodelling after breast cancer safe?

Complication prevalence following use of tutoplast-derived human acellular dermal matrix in prosthetic breast reconstruction: A retrospective review of 203 patients

Use of human acellular dermal matrix (ADM) during prosthetic breast reconstruction has increased. Several ADM products are available produced by differing manufacturing techniques. It is not known if outcomes vary with different products. This study reports the complication prevalence following use of a tutoplast-derived ADM (T-ADM) in prosthetic breast reconstruction. We performed a retrospective chart review of 203 patients (mean follow-up times 12.2 months) who underwent mastectomy and immediate prosthetic breast reconstruction utilizing T-ADM, recording demographic data, surgical indications and complication (infection, seroma, hematoma, wound healing exceeding three weeks and reconstruction failure). During a four-year period, 348 breast reconstructions were performed Complications occurred in 16.4% of reconstructed breasts. Infection occurred in 6.6% of breast reconstructions (3.7% - major infection, requiring intravenous antibiotics and 2.9% minor infection, requiring oral antibiotics only). Seromas occurred in 3.4% and reconstruction failure occurred in 0.6% of breast reconstructions. Analysis suggested that complication prevalence was significantly higher in patients with a BMI >30 (p=0.03). The complication profile following T-ADM use is this series is comparable to that reported for with other ADM products. T-ADM appears to be a safe and acceptable option for use in ADM-assisted breast reconstruction.

Sterile Acellular Dermal Collagen as a Treatment for Rippling Deformity of Breast

Prosthetic implants are frequently used for breast augmentation and breast reconstruction following mastectomy. Unfortunately, long-term aesthetic results of prosthetic breast restoration may be hindered by complications such as rippling, capsular contracture, and implant malposition. The advent of use of acellular dermal matrices has greatly improved the outcomes of prosthetic breast reconstruction. We describe a case of rippling deformity of breast that was treated using an acellular dermal matrix product, AlloMax. The patient presented with visible rippling of bilateral prosthetic breast implants as well as significant asymmetry of the breasts after multiple excisional biopsies for right breast ductal carcinoma in situ. A 6 × 10 cm piece of AlloMax was placed on the medial aspect of each breast between the implant and the skin flap. Follow-up was performed at 1 week, 3 months, and 1 year following the procedure. The patient recovered well from the surgery and there were no complications. At her first postoperative follow-up the patient was extremely satisfied with the result. At her 3-month and 1-year follow-up she had no recurrence of her previous deformity and no new deformity.

Evaluation of AlloMax Acellular Dermal Matrix for Objective Collagen Deposition

Acellular dermal matrix products are popular in various aspects of surgical reconstruction including hernia repairs and breast reconstructions. The goal of this study was to determine quantitative collagen weights of AlloMax (C. R. Bard, Inc. [Davol], Warwick, RI) and of contralateral dermis for composition comparison. A rehydrated sample of AlloMax was subcutaneously implanted on the dorsum of 18 male Wistar rats. Rats were randomly assigned to groups on the basis of in vivo implant time: 1, 3, and 6 weeks. At the end of the implant time, the AlloMax was removed and a section of contralateral dermis was excised as a control. Hydroxyproline, rat Collagen I and Collagen III, and neoangiogenesis were determined in the sections. The results are reported as mean ± standard error of the mean. Analysis of variance was used to evaluate the between-group differences. A p value of 0.05 or less was considered significant. Hydroxyproline was significantly increased in the 6-week AlloMax implant (26.19 ± 1.05 vs. 15.03 ± 3.29). Collagen I and Collagen III were significantly increased following 3 weeks in vivo (612.5% ± 98.0 vs. 312.9% ± 82.7, p < 0.05 Collagen I). Neoangiogenesis was significantly increased at 3 and 6 weeks in vivo (2.3 ± 0.3 and 1.9 ± 0.3). Acellular AlloMax was rapidly incorporated into the rat dorsum. The measurement parameters were greater than or equivalent to contralateral dermis in this study.

The Role of Acellular Dermal Matrices in Capsular Contracture

Despite advances in breast implant surgery, capsular contracture remains a challenging sequela of reconstructive and cosmetic breast implant surgery. Although there are established modalities for treatment, most recently, acellular dermal matrix products have been suggested to have a role in preventing or diminishing the pathologic process of capsular contracture. In this article, the author presents a review of the literature to highlight the level of evidence on the role of acellular dermal matrices in the treatment of capsular contracture.

Cost Analysis of Implant-Based Breast Reconstruction With Acellular Dermal Matrix

A comparative cost analysis of breast reconstruction using acellular dermal matrix (ADM) and traditional tissue expander-/implant-based techniques was carried out. Medicare reimbursement costs were calculated for tissue expander/implant alone (TE/I), TE/I with ADM (TE/I + ADM), and single-stage implant (SSI) with ADM (SSI + ADM). The most expensive procedure at baseline was TE/I + ADM ($11,255.78), followed by TE/I alone ($10,934.18), and SSI + ADM ($5,423.02). Incorporating the probability of complications as derived from the published literature into the cost analysis resulted in an increase in the excess cost of ADM-based procedures (TE/I + ADM, $11,829.02; TE/I, $11,238.60; SSI + ADM, $5,909.83). Although SSI + ADM have the lowest cost, not all patients are suitable candidates for this type of procedure. With increasing focus on healthcare expenditure, it is important that plastic surgeons are aware of the cost implications of using ADM products.

Complications of Acellular Dermal Matrices in Abdominal Wall Reconstruction

Acellular dermal matrices have been increasingly used in abdominal wall reconstruction. Unique characteristics of these grafts have allowed surgeons to reconstruct increasingly complex abdominal wall defects. This has resulted in a myriad of complications related to the acellular dermal matrix with unique management strategies as compared with synthetic mesh. A review of the literature was performed to identify studies evaluating the use and efficacy of acellular dermal matrices in abdominal wall reconstruction. Complication profiles were identified and are compared. Differences between porcine and human derivatives were identified. Hernia recurrence, infection, skin necrosis, and fluid collections were among the most common complications following abdominal wall reconstruction identified in the literature. Differences among various acellular dermal matrix products make certain types more suitable for abdominal wall reconstruction. Complications are frequent in abdominal wall reconstruction. Many acellular dermal matrices have properties that allow for conservative management and maintenance of reconstruction when complications occur. With traditional synthetic mesh reconstruction, complications likely result in mesh explantation and prolonged morbidity. With acellular dermal matrix reconstruction, however, more conservative treatment strategies will allow for mesh salvage.

Veritas® bovine pericardium for immediate breast reconstruction: a xenograft alternative to acellular dermal matrix products.

BackgroundThe technical advantages in utilizing human acellular dermal matrix (ADM) products as pectoral extenders in immediate breast reconstruction with tissue expanders or implants are well documented in the medical literature. In this study, the authors examine a commonly used biologic xenograft product that has not yet been described in the medical literature for use in immediate breast reconstruction to determine whether a lower overall complication rate is identified compared to published data on ADM products.MethodsA retrospective multicenter medical record review of data on 54 subjects in 93 tissue expander/implant-based, consecutive, immediate breast reconstructions from three surgeons at different institutions was performed in which Veritas® bovine pericardium was used as the biologic graft material for the pectoral extender.ResultsOver a 24-month period with an average of 11-month follow-up, complication rates using Veritas® in breast reconstruction for seroma formation (7.5 %), marginal skin flap necrosis (5.4 %) infection (6.5 %), and capsular contracture (0 %) were found to compare equally or favorably with statistically significant lower overall complications relative to one comparison study and lower rates of marginal skin flap necrosis relative to two comparison studies based upon previously published data from multisurgeon studies using ADM products.ConclusionsOverall complications were found to be lower with Veritas® than ADM products in comparable multisurgeon studies, though this was found to be statistically significant in only one comparison study.Level of Evidence: Level II, theraputic study.