DermACELL Acellular Dermal Matrix in Oncologic Breast Reconstruction: A Cohort Study and Systematic Review.
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ABSTRACT: Methods
We conducted a retrospective cohort study to compare outcomes between DermACELL and AlloDerm ADM, and a systematic review of the literature with a meta-analysis to evaluate clinical outcomes with DermACELL.Results
Seventy-four patients (128 breasts) undergoing immediate reconstruction were evaluated retrospectively. Chi-square analysis revealed no significant difference in postoperative outcomes between the two groups. Our systematic review of the literature yielded 12 total studies reporting DermACELL use for breast reconstruction encompassing 518 patients and 608 total breasts. A pooled analysis of the published data did not reveal a significant change in the rate of explantation when either chemotherapy or radiation was used. Meta-analysis did not show a significant difference in the rate of any of the complications evaluated.Conclusion
DermACELL is safe to use with a relatively consistent complication profile as compared with AlloDerm.
SUBMITTER: Swisher AR
PROVIDER: S-EPMC9208874 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundSingle-stage reconstruction is used widely after mastectomy. Prepectoral implant placement is a relatively new technique. This multicentre audit examined surgical outcomes following prepectoral reconstruction using acellular dermal matrix (ADM).MethodsAll patients who had a mastectomy with prepectoral breast reconstruction and ADM in the participating centres between January 2015 and December 2017 were included. Demographic and treatment details, and short- and long-term operative outcomes were recorded. Factors affecting complications and implant loss were analysed: age, BMI, smoking status, diabetes, vascular disease, laterality of surgery, previous ipsilateral breast surgery or radiotherapy, indication for surgery (invasive versus in situ carcinoma, or risk reduction), type of mastectomy, axillary clearance, breast volume, implant volume, and neoadjuvant and adjuvant chemotherapy.ResultsA total of 406 reconstructions were performed across 18 centres. Median follow-up was 9·65?months. Median hospital stay was 1?day. The 90-day unplanned readmission rate was 15·7 per cent, and the return-to-theatre rate 16·7 per cent. Some 15·3 per cent of patients had a major complication, with a 90-day implant loss rate of 4·9 per cent. A further six patients had delayed implant loss. In multivariable analysis, no factor was significantly associated with complications or implant loss.ConclusionPrepectoral breast reconstruction with ADM has satisfactory surgical outcomes. The duration of follow-up needs to be extended to examine outcomes in patients who received adjuvant radiotherapy.
| S-EPMC6996627 | biostudies-literature
Project description:BackgroundThe use of acellular dermal matrix (ADM) in one-stage immediate implant-based breast reconstruction (BR) may offer advantages over the two-stage expander-to-implant technique, but literature shows conflicting results. The aim of the present study was to compare these two techniques for immediate implant-based BR regarding postoperative complications, aesthetic correction procedures and aesthetic outcome.MethodsThe study was designed as an observational cohort study with 44 participants admitted for immediate implant-based BR at Department of Plastic Surgery, Aarhus University Hospital, Denmark. 21 patients underwent BR with a one-stage direct-to-implant technique using ADM and 23 patients underwent BR with a two-stage expander-to-implant technique. Follow-up time was 2 years.ResultsThe risk of implant loss was equal between groups; one-stage group 16% and two-stage group 17% whereas the risk of implant exchange (but not loss of BR) was 13% in the one-stage group compared to 7% in the two-stage group. The risk of at least one major complication were equal between groups; 28% and 24% but the risk of at least one minor complication was significantly higher in the two-stage group (41%) compared to the one-stage group (3%). Number of aesthetic corrections were equally frequent in the two treatment groups (one-stage group 1.8, two-stage group 1.5). Patient and investigator assessed aesthetic outcome was very high in both groups as well as the degree of symmetry between breasts. No capsular contracture Baker grade 3 or 4 was observed.ConclusionsThe present study design sets limitations for drawing wide conclusions. This study did not reveal any significant differences between the two breast reconstructive techniques besides a higher risk of minor complications in the two-stage group, that did, however, not lead to a higher risk of implant loss. With equally high satisfaction with the aesthetic result and no significant difference in number of aesthetic corrections between the two groups we suggest, that the one-stage approach using ADM may be feasible and allows the patient to achieve an implant-based BR with a minimum of surgeries and outpatient visits. The study was registered in ClinicalTrials.gov (NCT04209010).
| S-EPMC7882334 | biostudies-literature
Project description:BackgroundThe widespread implementation of acellular dermal matrix (ADM) has broadened the reconstructive repertoire for alloplastic breast reconstruction. ADM's role in the context of postoperative radiation therapy remains unclear. The present review will evaluate whether ADM reduces complication rates in patients undergoing post-mastectomy radiation therapy (PMRT).MethodsA healthcare librarian assisted in performing a search strategy of electronic databases MEDLINE (via Ovid), EMBASE, and CENTRAL. A combination of the keywords and Medical Subject Headings (MESH) to describe the various commercially available ADMs and terms for radiation therapy will be used. The search strategy will identify patients undergoing postoperative radiation following implant-based breast reconstruction and compare outcomes between those with and without ADM. Extracted data will include patient demographics, intraoperative data, and postoperative complications. Data on patient satisfaction and resource utilization will also be extracted if available. The references of selected works will be reviewed for additional studies meeting study criteria. Only peer-reviewed papers written in English will be included. The study data will be assessed for risk of bias and heterogeneity. Providing that sufficient studies can be identified, a meta-analysis will be performed. This review has been registered with PROSPERO (CRD42017056495).ConclusionsTo date, the short- and long-term performance of ADM in the context of postoperative radiation remains unclear. The objective of the present review will be to critically evaluate the literature with the intention of improving postoperative outcomes in the context of mastectomy and radiation.
| S-EPMC6383242 | biostudies-literature
Project description:PurposeWe systematically reviewed the literature to compare the clinical and radiologic outcomes and retear rates of superior capsular reconstruction (SCR) using fascia lata autograft (FLA) versus human dermal allograft (HDA) in cases of massive irreparable rotator cuff tears.MethodsSearches of Pub Med and Cochrane Library identified clinical studies addressing SCR using FLA and HDA. Two reviewers independently screened the titles, abstracts and full texts to extract data from eligible studies. Reported outcome measures were descriptively analyzed.ResultsA total of 6 studies with 2 study groups satisfied the inclusion criteria. The number of shoulders in the HDA group was 155, and in the FLA group, the number was 140 shoulders. The mean age at time of surgery for the HDA group and the FLA group was 60.49 years and 65.8 years, respectively, and the mean follow-up was 15.2 months and 44.6 months, respectively. Active elevation improved from of 121°-130° to 158°-160° in the HDA group and from 74.8°-133° to 130.4°-146° in the FLA group. Active external rotation improved from 36°-45° in the HDA group and from 13°-28° to 30°-43° in the FLA group. The Visual Analog Scale for pain improved from 4-6.25 to 0.38-1.7 points in the HDA group, whereas in the FLA group, it improved from 6-2.5 points. In the HDA group, American Shoulder and Elbow Surgeons scores improved from 42-52 to 77.5-86.5, whereas in the FLA group scores improved from 35-54.4 to 73.7-94.3. The acromiohumeral distance improved in both groups. The retear rate was 3.4%-55% in the HDA group and 4.5%-29% % in the FLA group.ConclusionsArthroscopic SCR for massive, irreparable rotator cuff tears using both fascia lata allograft and human dermal allograft leads to improvement in clinical outcomes and radiologic outcomes. There is a lower retear rate in fascia lata allografts. The current literature is heterogeneous and has low levels of evidence.Level of evidenceLevel IV, systematic review of level IV studies.
| S-EPMC7451904 | biostudies-literature
Project description:BACKGROUND: The 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. METHODS: A 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. RESULTS: Over 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. CONCLUSIONS: Overall 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.
| S-EPMC3443340 | biostudies-literature
Project description:BackgroundHuman-derived acellular dermal matrix (ADM) has been widely used as an effective alternative to autologous grafts in tympanoplasty. However, evidence of ADM as an alternative to autologous grafts in the repair of tympanic membrane (TM) perforation still lacks adequate empirical evidence.ObjectivesTo determine the clinical safety and efficacy of human-derived ADM as TM graft material for tympanoplasty.Data sourcesThe PubMed, EMBASE, Cochrane Library, EBSCO, Ovid, Scopus, and Web of Science databases and reference lists of the retrieved articles were searched, with no language restriction.Selection criteriaAll randomized controlled trials and retrospective cohort studies that compared the use of human-derived ADM and autologous grafts in tympanoplasty for TM perforation were included.Data collection and analysisTwo review authors independently assessed risk of bias in the included studies and extracted data. The pooled results for continuous data were reported as a mean difference (MD) and 95% confidence intervals (CI). For dichotomous data, odds risk (OR) with 95% CI was used. ChI2 statistic and Galbraith plots were used to assess the heterogeneity. Publication bias was assessed with a funnel plot and Egger's test.Main resultsFive retrospective cohort studies and four randomized controlled studies with a total of 610 participants were included in the meta-analysis. No significant differences in graft success (OR: 0.71 [0.39, 1.29], p = 0.26), air-bone gap (ABG) reduction (MD: - 0.59 [- 3.81, 1.19], p = 0.51), or complications (OR: 1.23 [0.07, 20.64], p = 0.89) were found between the ADM group and autologous graft group. The use of ADM significantly shortened tympanoplasty surgery time (MD: - 16.14 [- 21.22, - 11.07], p < 0.00001) and reduced postoperative pain (MD: - 2.57 [- 3.57, - 1.58], p < 0.00001) compared with the autologous graft group.ConclusionHuman-derived ADM might be an effective alternative to autologous grafts for tympanoplasty. However, some of the studies that were included in the present meta-analysis had rather low methodological quality, and more adequately designed clinical trials should be performed in the future.
| S-EPMC8261972 | biostudies-literature
Project description:Background:The aim of this systematic review was to evaluate whether patients with gingival recession would benefit from an acellular dermal matrix graft (ADMG) in ways that are comparable to the gold standard of the subepithelial connective tissue graft (SCTG). Materials and Methods:A systematic review and meta-analysis comparing ADMG to SCTG for the treatment of Miller Class I and II recession defects was conducted according to PRISMA guidelines. PubMed, Excerpta Medica Database, and Cochrane Central Register of Controlled Trials databases were searched up to March 2016 for controlled trials with minimum 6 months duration. The primary outcome was root coverage; secondary outcomes included attachment level change, keratinized tissue (KT) change, and patient-based outcomes. Both authors independently assessed the quality of each included trial and extracted the relevant data. Results:From 158 potential titles, 17 controlled trials were included in the meta-analysis. There were no differences between ADMG and SCTG for mean root coverage, percent root coverage, and clinical attachment level gain. ADMG was statistically better than SCTG for gain in width of KT (-0.43 mm; 95% confidence interval: -0.72, -0.15). Only one study compared patient-based outcomes. Conclusion:This review found that an ADMG would be a suitable root coverage substitute for an SCTG when avoidance of the second surgical site is preferred.
| S-EPMC5846239 | biostudies-literature
Project description:The two-stage tissue expander/implant (TE/I) reconstruction is currently the gold standard method of implant-based immediate breast reconstruction in North America. Recently, however, there have been numerous case series describing the use of one-stage direct to implant reconstruction with the aid of acellular dermal matrix (ADM). In order to rigorously investigate the novel application of ADM in one-stage implant reconstruction, we are currently conducting a multicentre randomized controlled trial (RCT) designed to evaluate the impact on patient satisfaction and quality of life (QOL) compared to the two-stage TE/I technique.The MCCAT study is a multicenter Canadian ADM trial designed as a two-arm parallel superiority trial that will compare ADM-facilitated one-stage implant reconstruction compared to two-stage TE/I reconstruction following skin-sparing mastectomy (SSM) or nipple-sparing mastectomy (NSM) at 2 weeks, 6 months, and 12 months. The source population will be members of the mastectomy cohort with stage T0 to TII disease, proficient in English, over the age of 18 years, and planning to undergo SSM or NSM with immediate implant breast reconstruction. Stratified randomization will maintain a balanced distribution of important prognostic factors (study site and unilateral versus bilateral procedures). The primary outcome is patient satisfaction and QOL as measured by the validated and procedure-specific BREAST-Q. Secondary outcomes include short- and long-term complications, long-term aesthetic outcomes using five standardized photographs graded by three independent blinded observers, and a cost effectiveness analysis.There is tremendous interest in using ADM in implant breast reconstruction, particularly in the setting of one-stage direct to implant reconstruction where it was previously not possible without the intermediary use of a temporary tissue expander (TE). This unique advantage has led many patients and surgeons alike to believe that one-stage ADM-assisted implant reconstruction should be the procedure of choice and should be offered to patients as the first-line treatment. We argue that it is crucial that this technique be scientifically evaluated in terms of patient selection, surgical technique, complications, aesthetic outcomes, cost-effectiveness, and most importantly patient-reported outcomes before it is promoted as the new gold standard in implant-based breast reconstruction.ClinicalTrials.gov: NCT00956384.
| S-EPMC3842809 | biostudies-literature
Project description:Atraumatic instability of the hip has become an increasingly studied occurrence in recent years. There are several established surgical techniques that help restore stability of the native hip joint. In some cases, these procedures are not an option. As the phenomenon has become recognized more frequently, a greater number of revision surgeries are warranted in patients with ligamentous laxity. A durable solution for irreparable microinstability needs to be formulated to address this vulnerable patient demographic. We describe the surgical technique for capsular reconstruction with acellular dermal extracellular matrix.
| S-EPMC5124028 | biostudies-literature
Project description:BACKGROUND:In the multicentre randomized trial BRIOS (Breast Reconstruction In One Stage), direct-to-implant (DTI) breast reconstruction with an acellular dermal matrix (ADM) was associated with a markedly higher postoperative complication rate compared with two-stage tissue expander/implant breast reconstruction. This study aimed to identify factors that contribute to the occurrence of complications after DTI ADM-assisted breast reconstruction. METHODS:Data were obtained from the BRIOS study, including all patients treated with DTI ADM-assisted breast reconstruction. Logistic regression analyses were performed to identify factors predictive of postoperative complications. RESULTS:Fifty-nine patients (91 breasts) were included, of whom 27 (35 breasts) developed a surgical complication. Reoperations were performed in 29 breasts (32 per cent), with prosthesis removal in 22 (24 per cent). In multivariable analyses, mastectomy weight was associated with complications (odds ratio (OR) 1·94, 95 per cent c.i. 1·33 to 2·83), reoperations (OR 1·70, 1·12 to 2·59) and removal of the implant (OR 1·55, 1·11 to 2·17). Younger patients (OR 1·07, 1·01 to 1·13) and those who received adjuvant chemotherapy (OR 4·83, 1·15 to 20·24) more frequently required reoperation. In univariable analyses, adjuvant radiotherapy showed a trend towards more complications (OR 7·23, 0·75 to 69·95) and removal of the implant (OR 5·12, 0·76 to 34·44), without reaching statistical significance. CONCLUSION:Breast size appeared to be the most significant predictor of complications in DTI ADM-assisted breast reconstruction. The technique should preferably be performed in patients with small to moderate sized breasts. Registration number: NTR5446 ( http://www.trialregister.nl).
| S-EPMC6099293 | biostudies-literature