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Breast (Edinburgh, Scotland) Feb 2021The impact of neoadjuvant chemotherapy (NACT) on surgical outcomes following immediate breast reconstruction (IBR) remains unclear. While it is generally considered safe... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The impact of neoadjuvant chemotherapy (NACT) on surgical outcomes following immediate breast reconstruction (IBR) remains unclear. While it is generally considered safe practice to perform an IBR post NACT, reported complication rates in published data are highly variable with the majority of studies including fewer than 50 patients in the NACT and IBR arm. To evaluate this further, we conducted a systematic review and meta-analysis on the effect of NACT on autologous and implant based immediate breast reconstructions. We aimed to assess for differences in the post-operative course following IBR between patients who received NACT with those who did not.
METHODS
PubMed, EMBASE, and Cochrane Library were searched from 1995 to Sept 2, 2020 to identify articles that assessed the impact of NACT on IBR. All included studies assessed outcomes following IBR. Only studies comparing reconstructed patients receiving NACT to a control group of women who did not receive NACT were included. Unadjusted relative risk of outcomes between patients who received or did not receive NACT were synthesized using a fixed-effect meta-analysis. The evidence was assessed using the Newcastle Ottawa Scale scores and GRADE. Primary effect measures were risk ratios (RRs) with 95% confidence intervals.
RESULTS
A total 17 studies comprising 3249 patients were included in the meta-analyses. Overall, NACT did not increase the risk of complications after immediate breast reconstructions (risk ratio [RR]: 0.91, 95% CI 0.74 to 1.11, p = 0.34). There was a moderate, but not significant, increase in flap loss following NACT compared with controls (RR: 1.23, 95% CI 0.70 to 2.18, p = 0.47; I = 0%). Most notably, there was a statistically significant increase in implant/expander loss after NACT (RR: 1.54, 95% CI 1.04 to 2.29, p = 0.03; I = 34%). NACT was not shown to significantly increase the incidence of hematomas, seromas or wound complications, or result in a significant delay to commencing adjuvant therapy (RR: 1.59, 95% CI 0.66 to 3.87, p = 0.30).
CONCLUSION
Immediate breast reconstruction after NACT is a safe procedure with an acceptable post-operative complication profile. It may result in a slight increase in implant loss rates, but it does not delay commencing adjuvant therapy.
Topics: Breast Neoplasms; Chemotherapy, Adjuvant; Combined Modality Therapy; Female; Humans; Mammaplasty; Neoadjuvant Therapy; Postoperative Complications
PubMed: 33341706
DOI: 10.1016/j.breast.2020.11.023 -
Journal of Biomaterials Applications Feb 2020Medical devices made of polydioxanone (a synthetic biodegradable polymer) have been available since the early 1980s. However, no review regarding their performance and...
BACKGROUND
Medical devices made of polydioxanone (a synthetic biodegradable polymer) have been available since the early 1980s. However, no review regarding their performance and safety has been published.
OBJECTIVE
This systematic review intends to review and assess commercially available polydioxanone implants and their safety and performance in patients.
METHODS
We searched for approved polydioxanone implants in several Food and Drug Administration databases. Then, we performed a literature search for publications and clinical trials where polydioxanone devices were implanted in patients. This search was performed on MEDLINE, Embase, Scopus and other databases. Safety and performance of polydioxanone implants in patients were assessed and compared with the implantation of non-polydioxanone devices, when possible, based on scoring systems developed by the authors that analyse surgical site infection rates, inflammatory reaction rates, foreign body response, postoperative pain and fever.
RESULTS
Food and Drug Administration databases search revealed that 48 implants have been approved since 1981, with 1294 adverse reactions or product malfunction in the last decade and 16 recalls. A total of 49 clinical trials and 104 scientific publications were found. Polydioxanone sutures and meshes/plates had low rates of surgical site infection, inflammatory reaction, foreign body response and postoperative fever. Polydioxanone clips/staples reported high rates of surgical site infection, postoperative fever and pain, with sub-optimal clinical performance and poor safety rates. The remaining implants identified showed high levels of safety and performance. Safety scores of polydioxanone implants and non-polydioxanone alternatives are similar. Polydioxanone monofilament sutures perform better than non-polydioxanone alternatives but performance did not differ with remaining polydioxanone implant types.
CONCLUSIONS
Although polydioxanone clips/staples should be implanted with caution and monitored carefully, in general, safety and performance scores of other polydioxanone implants did not differ from non-polydioxanone alternatives. This review will be a useful reference for researchers and industries developing new polydioxanone medical devices.
Topics: Absorbable Implants; Biocompatible Materials; Device Approval; Humans; Inflammation; Medical Device Recalls; Polydioxanone
PubMed: 31771403
DOI: 10.1177/0885328219888841 -
International Journal of Antimicrobial... Jan 2024Adjunctive rifampicin for implant-associated infections is controversial. This study investigated the clinical outcomes of rifampicin combination therapy compared with... (Meta-Analysis)
Meta-Analysis
OBJECTIVES
Adjunctive rifampicin for implant-associated infections is controversial. This study investigated the clinical outcomes of rifampicin combination therapy compared with monotherapy in treating prosthetic joint infection (PJI) or prosthetic valve endocarditis (PVE) due to staphylococci and streptococci.
METHODS
A systematic search was performed from inception to 13 June 2022 in Embase, MEDLINE, Cochrane and Web of Science to investigate the clinical outcomes of rifampicin combination therapy compared with monotherapy in treating staphylococcal and streptococcal PJI or PVE. Randomised controlled trials (RCTs) and observational studies were included in the systematic review and meta-analysis.
RESULTS
Fourteen studies were included. A moderate quality of evidence was found in favour of rifampicin in patients with staphylococcal PJI who underwent a debridement, antibiotics and implant retention (DAIR) procedure [odds ratio = 2.49, 95% confidence interval (CI) 1.93-3.23]. Including the two RCTs only, adding rifampicin to the antibiotic regimen after DAIR was also in favour of rifampicin, but this was not statistically significant (risk ratio = 1.27, 95% CI 0.79-2.04; n = 126). Pooling data for patients with staphylococcal PJI who underwent a two-stage procedure showed that adding rifampicin was not associated with therapeutic success. Limited evidence was found for the use of rifampicin for PVE caused by staphylococci.
CONCLUSIONS
Adding rifampicin in the treatment of staphylococcal PJI treated by DAIR clearly increased the likelihood for therapeutic success. The clinical benefit of adjunctive rifampicin in the treatment of other staphylococci and streptococci implant-associated infections is still unclear.
Topics: Humans; Anti-Bacterial Agents; Arthritis, Infectious; Debridement; Prosthesis-Related Infections; Retrospective Studies; Rifampin; Staphylococcus; Streptococcus; Treatment Outcome
PubMed: 37875179
DOI: 10.1016/j.ijantimicag.2023.107015 -
Journal of Dentistry (Shiraz, Iran) Sep 2022Bone morphogenetic protein (BMP), a potential osteoinductive agent, was systematically reviewed for merits and demerits when used as a bone additive that was intervened...
STATEMENT OF THE PROBLEM
Bone morphogenetic protein (BMP), a potential osteoinductive agent, was systematically reviewed for merits and demerits when used as a bone additive that was intervened during the surgical phase of dental implant placement; and suitable drug carriers that could withstand the functional load and deliver BMP at its lowest concentration.
PURPOSE
To identify the carriers and concentration of BMP acceptable during surgical phase of implant placement and evaluate its efficacy in bone gain and osseointegration.
MATERIALS AND METHOD
The study design was systematic review. Literature search as per PICO format was carried out within a time range from 2000 to July 2021. The review fol-lowed PRISMA guidelines and registered with the PROSPERO (CRD42020171667). The focus question included the population with an intra-oral implant placed in both animal and human models that were intervened with BMP-2 as an external additive biomaterial during the surgical phase. 2631 articles selected from the initial search were systematically filtered and yielded 16 articles that were qualitatively analysed.
RESULTS
The inter-rater reliability and level of agreement were 93.71%, κ(Kappa)>0.81 re-spectively. Results revealed the collagen carrier was commonly used for BMP delivery but lacked the property to withstand functional load and sustained release. BMP concentration varied in the range of 0.215μg to 0.8mg and the study revealed significantly indifferent out-come with low dose compared to the highest dose. BMP supplement showed better osseointe-gration in comparison with non-supplemented sites during the early period (within 6 months).
CONCLUSION
BMP at lower concentrations and with appropriate carriers, collagen sponge, hydroxyapatite/tricalcium phosphate (HA/TCP) with a bio ceramic bulking agent, and poly (D, L-lactide-co-glycolic acid) (PLGA) reinforced with gelatin/HA/TCP accelerated bone growth during the initial stages of healing. Further long-term clinical trials for dental implant, analysing the sustained release of BMP with biodegradable and load-bearing carriers should be considered.
PubMed: 36588970
DOI: 10.30476/DENTJODS.2021.90931.1536 -
Clinical Oral Investigations Oct 2022Bioactive glass and hydroxyapatite are biocompatible materials used as an adjunct to various dental materials. The present study aimed to evaluate the occlusion effects... (Review)
Review
OBJECTIVE
Bioactive glass and hydroxyapatite are biocompatible materials used as an adjunct to various dental materials. The present study aimed to evaluate the occlusion effects of bioactive glasses and hydroxyapatite on dental tubules.
MATERIALS AND METHODS
We searched the PubMed/Medline, Embase, and Web of Science databases for the relevant records. The methodological quality of the studies was assessed by an accepted quality assessment tool.
RESULTS
From the electronic databases, 372 articles were retrieved. After evaluating the records, 35 in vitro studies were included. The studies revealed a low risk of bias. The primary outcomes from bioactive glass studies demonstrated the potential efficacy of both bioactive glass and hydroxyapatite in dentin tubule occlusion compared to the control.
CONCLUSION
The current systematic review showed that bioactive glass and hydroxyapatite could effectively occlude the dentinal tubules. Thus, desensitizing agents containing bioactive glass and hydroxyapatite can be used to manage dentin hypersensitivity (DH). However, long-term follow-up clinical trials are required in the future before definitive recommendations can be made.
CLINICAL RELEVANCE
This work achieved a satisfactorily systematic review for assessing desensitizing agents containing bioactive glass and hydroxyapatite in dentine hypersensitivity treatments recommended for clinical practice and research.
Topics: Biocompatible Materials; Dental Materials; Dentin; Dentin Desensitizing Agents; Dentin Sensitivity; Durapatite; Glass; Humans; Microscopy, Electron, Scanning
PubMed: 35871701
DOI: 10.1007/s00784-022-04639-y -
Frontiers in Cellular and Infection... 2023Peri-implant diseases are pathological conditions that affect the survival of dental implants. Etiological studies are limited, accepting a prevalence of 20% at the... (Meta-Analysis)
Meta-Analysis Review
Peri-implant diseases are pathological conditions that affect the survival of dental implants. Etiological studies are limited, accepting a prevalence of 20% at the implant level and 24% at the patient level. The benefits of adjuvant metronidazole are controversial. A systematic review and meta-analysis of RCTs according to PRISMA and PICOS was performed with an electronic search over the last 10 years in MEDLINE (PubMed), WOS, Embase, and Cochrane Library. The risk of bias was measured using the Cochrane Risk of Bias tool and the methodological quality using the Jadad scale. Meta-analysis was performed with RevMan version 5.4.1, based on mean difference and standard deviation, with 95% confidence intervals; the random-effects model was selected, and the threshold for statistical significance was defined as < 0.05. A total of 38 studies were collected and five were selected. Finally, one of the studies was eliminated because of unanalyzable results. All studies reached a high methodological quality. A total of 289 patients were studied with follow-up periods from 2 weeks to 1 year. Statistical significance was only found, with respect to the use of adjunctive metronidazole, in the pooled analysis of the studies ( = 0.02) and in the analysis of the radiographic values reported on peri-implant marginal bone levels, in the studies with a 3-month follow-up ( = 0.03). Discrepancies in the use of systemic metronidazole require long-term randomized clinical trials (RCTs) to determine the role of antibiotics in the treatment of peri-implantitis.
Topics: Humans; Peri-Implantitis; Metronidazole; Anti-Bacterial Agents; Combined Modality Therapy; Bias
PubMed: 37287463
DOI: 10.3389/fcimb.2023.1149055 -
Frontiers in Pharmacology 2022To compare the efficacy and safety of advanced intravitreal therapeutic regimens, including a dexamethasone implant at 350 and 700 μg; a fluocinolone acetonide (FA)...
To compare the efficacy and safety of advanced intravitreal therapeutic regimens, including a dexamethasone implant at 350 and 700 μg; a fluocinolone acetonide (FA) implant, 0.2 µg/day, 0.59 and 2.1 mg; intravitreal bevacizumab, 1.25 mg; intravitreal ranibizumab, 0.5 mg; intravitreal triamcinolone acetonide (IVTA), 2 and 4 mg; and standard of care (SOC, systemic therapy) for noninfectious uveitis. We searched the Cochrane Library database, EMBASE, Medline, clinicaltrials.gov until April 2021 with 13 RCTs (1806 participants) identified and conducted a pairwise and Bayesian network meta-analysis with random effects. No specific regimen showed a statistically significant advantage or disadvantage to another treatment regimen with regard to efficacy. However, the FA implant, 0.59 mg was associated with a higher risk of cataract (RR 4.41, 95% CI 1.51-13.13) and raise in intraocular pressure (IOP) (RR 2.53 95% CI 1.14-6.25) compared with SOC at 24 months. IVTA, 4 mg at 6 months was associated with lower risk of IOP rising compared with FA implant, 0.2 µg/day at 36 months (RR 3.43 95% CI 1.12-11.35). No intravitreal therapeutic regimens showed a significant advantage or disadvantage with regard to efficacy. However, SOC was associated with lower risk of side effects compared with FA implants. IVTA, 4 mg, might be the best choice with lowest risk of IOP rising. clinicaltrials.gov, identifier CRD42020172953.
PubMed: 35450045
DOI: 10.3389/fphar.2022.749312 -
Journal of Plastic, Reconstructive &... Dec 2023The impact of neoadjuvant chemotherapy (NACT) on the complication rate after implant-based and autologous breast reconstruction remains unclear. The aim of this study... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The impact of neoadjuvant chemotherapy (NACT) on the complication rate after implant-based and autologous breast reconstruction remains unclear. The aim of this study was to systematically review and perform a meta-analysis of previously published studies on immediate breast reconstruction (IBR) in breast cancer patients treated with NACT compared with controls.
METHODS
PubMed and EMBASE were searched to identify studies assessing the impact of NACT on major and minor complications after IBR. The primary effect measures were relative risk (RR), 95% confidence interval (95% CI), and p-value.
RESULTS
Eight studies comprising 51,731 patients were included in the meta-analysis. Of these, 5161 patients received NACT and 46,570 patients did not receive NACT. In regard to major complications, NACT did not statistically significant increase the rate of reconstructive failure (RR = 1.35, 95% CI = 0.96-1.91, p = 0.09), the rate of mastectomy skin-flap necrosis (RR = 1.39, 95% CI = 0.61-3.17, p = 0.44), or the rate of reoperation (RR = 1.09, 95% CI = 0.87-1.37, p = 0.45). Regarding minor complications, NACT did not significantly increase the rate of wound complications (RR = 1.05, 95% CI = 0.87-1.28, p = 0.62). In a subgroup analysis of implant-based breast reconstruction following NACT, single-stage direct-to-implant (DTI) had a significantly lower implant failure rate compared with two-staged tissue expander/implant (TE/I) (RR = 0.43, 95% CI = 0.26-0.71, p = 0.0011).
CONCLUSION
NACT did not increase the major or minor complication rate after IBR with either autologous tissue or implants. Thus, NACT and IBR should be considered safe procedures. The review of studies describing patients undergoing implant-based breast reconstruction following NACT could indicate that single-stage DTI was a safer procedure than two-staged TE/I. However, the association requires further evaluation.
Topics: Humans; Female; Mastectomy; Neoadjuvant Therapy; Breast Neoplasms; Mammaplasty; Postoperative Complications; Treatment Outcome; Breast Implants; Retrospective Studies
PubMed: 37804643
DOI: 10.1016/j.bjps.2023.09.048 -
Lasers in Medical Science Oct 2022Antimicrobial photodynamic therapy (aPDT) has been proposed as an adjunctive treatment strategy for peri-implant diseases. This systematic review aimed to determine... (Meta-Analysis)
Meta-Analysis Review
Antimicrobial photodynamic therapy (aPDT) has been proposed as an adjunctive treatment strategy for peri-implant diseases. This systematic review aimed to determine whether aPDT as an adjunct to mechanical debridement has an additional benefit for smokers with peri-implant diseases. Randomized controlled trials (RCTs), which evaluated the clinical outcomes of mechanical debridement alone versus mechanical debridement + aPDT among smokers, were considered eligible to be included. The primary outcome was bleeding on probing (BOP) and secondary outcomes included probing depth (PD), plaque index (PI), and crestal bone loss (CBL). Meta-analyses using a random-effects model were conducted to calculate the mean difference (MD) with a 95% confidence interval (CI). The quality of evidence was assessed according to Grading of Recommendations Assessment, Development and Evaluation (GRADE). A total of four RCTs (188 participants) were included. The aPDT group showed significantly improved PD (MD = - 1.26, 95% CI = - 2.19 to - 0.32, p = 0.008) and PI (MD = - 10.6%, 95% CI = - 14.46 to - 6.74%, p = 0.0001) compared with mechanical debridement group at 3-month follow-up. No significant difference in bleeding on probing (BOP) was observed at 3-month follow-up (MD = - 0.60%, 95% CI = - 2.36 to 1.16%, p = 0.50). The subgroup analyses on photosensitizers demonstrated significant differences between the two groups on PD (MD = - 1.23, 95% CI = - 2.41 to - 0.05, p = 0.04) and PI (MD = - 12.33, 95% CI = - 14.74 to - 9.92, p < 0.00001) by the use of methylene blue (MB). Within the limitation of this study, compared with mechanical debridement alone, combined use of aPDT was more effective in reducing PD and PI in smokers at 3-month follow-up. MB was a predictable photosensitizer for aPDT. However, the findings should be interpreted with caution due to the limited number of included studies, methodological deficiencies, and heterogeneity between studies.
Topics: Anti-Bacterial Agents; Anti-Infective Agents; Combined Modality Therapy; Debridement; Humans; Methylene Blue; Peri-Implantitis; Photochemotherapy; Photosensitizing Agents; Smokers
PubMed: 35896900
DOI: 10.1007/s10103-022-03592-2 -
Journal of Plastic, Reconstructive &... Jul 2023The impact of chemotherapy on complications following breast reconstruction surgery (BRS) is currently inconclusive. This meta-analysis investigates the impact of... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The impact of chemotherapy on complications following breast reconstruction surgery (BRS) is currently inconclusive. This meta-analysis investigates the impact of chemotherapy on complication rates in BRS.
METHODS
Preferred Reporting in Systematic Review and Meta-Analysis (PRISMA) guidelines was used to search relevant studies published from January 2006 to March 2022. The complication rates of neoadjuvant systemic therapy (NST) and adjuvant systemic therapy (AST) were analyzed via RevMan software 5.4, and a P value of< 0.05 was considered significant. The quality of selected studies was performed using the Newcastle-Ottawa scale for quality assessment.
RESULTS
A total of 18 studies comprising 49,217 patients were included. There was no significant difference in the total complications rate, major complications, or minor complications between NST and BRS or control. The rate of wound dehiscence was higher in the NST group compared with the BRS only group [RR= 1.54, 95% CI, (1.08, 2.18), P = 0.02], and the rate of infection was lower in the NST group compared with the BRS only group, [RR= 0.75, 95% CI, (0.61, 0.94), P = 0.01]. No significant difference in the rates of hematoma, seroma, skin necrosis, and implant loss was detected between NST and AST, or NST with BRS only. No statistically significant differences in total complication rates were observed between flap and implant BRS types (P = 0.88).
CONCLUSION
No significant differences between AST and NST were detected for complications. Significantly, NST had more wound dehiscence and less infection rates compared with BRS only groups, possibly reflecting selection bias or issues in the design of reported studies.
LEVEL OF EVIDENCE
I.
Topics: Humans; Female; Postoperative Complications; Mammaplasty; Surgical Flaps; Combined Modality Therapy; Neoadjuvant Therapy; Breast Neoplasms
PubMed: 37182249
DOI: 10.1016/j.bjps.2023.04.007