Allograft vs Xenograft Bioprosthetic Mesh in Tissue Expander Breast Reconstruction: A Blinded Prospective Randomized Controlled Trial

2021 ◽  
Author(s):  
Malke Asaad ◽  
Jesse C Selber ◽  
David M Adelman ◽  
Donald P Baumann ◽  
Victor J Hassid ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Breast Reconstruction ◽  
Controlled Trial ◽  
Tissue Expander ◽  
Final Analysis ◽  
Immediate Breast Reconstruction ◽  
Complication Rates ◽  
Level Of Evidence ◽  
Dermal Matrix ◽  
Randomized Controlled

Abstract Background With the increased use of acellular dermal matrix (ADM) in breast reconstruction, the number of available materials has increased. There is a relative paucity of high-quality outcomes data for use of different ADMs. Objectives The goal of this study was to compare the outcomes between a human (HADM) and a bovine ADM (BADM) in implant-based breast reconstruction. Methods A prospective, single-blinded, randomized controlled trial was conducted to evaluate differences in outcomes between HADM and BADM for patients undergoing immediate tissue expander breast reconstruction. Patients with prior radiation to the index breast were excluded. Patient and surgical characteristics were collected and analyzed. Results From April 2011 to June 2016, a total of 90 patients were randomized to a mesh group, with 68 patients (HADM, 36 patients/55 breasts; BADM, 32 patients/48 breasts) included in the final analysis. Baseline characteristics were similar between the 2 groups. No significant differences in overall complication rates were identified between HADM (n = 14, 25%) and BADM (n = 13, 27%) (P = 0.85). Similar trends were identified for major complications and complications requiring reoperation. Tissue expander loss was identified in 7% of HADM patients (n = 4) and 17% of BADM patients (n = 8) (P = 0.14). Conclusions Similar complication and implant loss rates were found among patients undergoing immediate tissue expander breast reconstruction with HADM or BADM. Regardless of what material is used, careful patient selection and counseling, and cost consideration, help to improve outcomes and sustainability in immediate breast reconstruction. Level of Evidence: 2

Post-Mastectomy Surgical Pocket Irrigation With Triple Antibiotic Solution vs Chlorhexidine Gluconate: A Randomized Controlled Trial Assessing Surgical Site Infections in Immediate Tissue Expander Breast Reconstruction

2021 ◽  
Author(s):  
Lyly Nguyen ◽  
Ashkan Afshari ◽  
Japjit Green ◽  
Jeremy Joseph ◽  
Jun Yao ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Breast Reconstruction ◽  
Controlled Trial ◽  
Tissue Expander ◽  
Surgical Site Infections ◽  
Chlorhexidine Gluconate ◽  
Bilateral Mastectomy ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Antibiotic Solution

Abstract Background Post-mastectomy pocket irrigation solution choice is debated and primarily surgeon dependent. We compare triple antibiotic solution (TAS) to 0.05% chlorhexidine gluconate (CHG). Objectives The purpose of this study was to determine surgical site infection (SSI) rates after using TAS vs CHG for breast pocket irrigation in immediate tissue expander breast reconstruction. Methods A prospective, blinded, randomized controlled trial was performed in patients (18-81 years old) undergoing bilateral mastectomy with tissue expander (TE) reconstruction. In each patient, one mastectomy pocket was randomized to TAS and the other to CHG. Both the TE and the pocket were irrigated in the respective solution. The primary outcome was the incidence of surgical site infections (SSI). Secondary outcomes were rates of mastectomy flap necrosis, hematoma, and seroma. Results Eighty-eight patients undergoing bilateral immediate breast reconstruction were enrolled. Demographic and operative characteristics were equivalent as each patient served as their own control. Between the TAS and CHG groups, there was no difference in the incidence of SSI (5 [4.5%] vs 7 [8.0%], p = 0.35), including minor infections (2 [2.3%] vs 1 [1.1%], p = 0.56), major infections (2 [2.3%] vs 6 [6.8%], p = 0.15), and those resulting in explantation (2 [2.3%] vs 5 [4.5%], p = 0.25). There was also no difference in necrosis, hematoma, or seroma formation. No patients who developed SSI had radiation. Conclusions This study does not demonstrate a statistically significant difference in SSI between TAS and CHG irrigation, though TAS approached statistical significance for lower rates of infectious complications.

scholarly journals Safety and Efficacy of Smooth Surface Tissue Expander Breast Reconstruction

2018 ◽  
Vol 40 (1) ◽  
pp. 53-62
Author(s):  
Berry Fairchild ◽  
Warren Ellsworth ◽  
Jesse C Selber ◽  
David P Bogue ◽  
Dmitry Zavlin ◽  
...  
Keyword(s):  
Breast Reconstruction ◽  
Smooth Surface ◽  
Skin Flap ◽  
Tissue Expander ◽  
Immediate Breast Reconstruction ◽  
Textured Surface ◽  
Complication Rates ◽  
Level Of Evidence ◽  
Safety And Efficacy ◽  
Early Results

Abstract Background Traditional 2-stage breast reconstruction involves placement of a textured-surface tissue expander (TTE). Recent studies have demonstrated textured surface devices have higher propensity for bacterial contamination and biofilm formation. Objectives The purpose of this study was to evaluate the safety and efficacy of smooth surface tissue expanders (STE) in immediate breast reconstruction. Methods The authors retrospectively reviewed consecutive women who underwent STE breast reconstruction from 2016 to 2017 at 3 institutions. Indications and outcomes were evaluated. Results A total 112 patients underwent STE reconstruction (75 subpectoral, 37 prepectoral placement), receiving 173 devices and monitored for a mean follow-up of 14.1 months. Demographics of patients included average age of 53 years and average BMI of 27.2 kg/m2, and 18.6% received postmastectomy radiation therapy. Overall complication rates were 15.6% and included mastectomy skin flap necrosis (10.4%), seroma (5.2%), expander malposition (2.9%), and infection requiring intravenous antibiotic therapy (3.5%). Six (3.5%) unplanned reoperations with explantation were reported for 3 infections and 3 patients requesting change of plan with no reconstruction. Conclusions STEs represent a safe and efficacious alternative to TTE breast reconstruction with at least equitable outcomes. Technique modification including tab fixation, strict pocket control, postoperative bra support, and suture choice may contribute to observed favorable outcomes and are reviewed. Early results for infection control and explantation rate are encouraging and warrant comparative evaluation for potential superiority over TTEs in a prospective randomized trial. Level of Evidence: 4

The Effect of Lavender Oil on Perioperative Pain, Anxiety, Depression, and Sleep after Microvascular Breast Reconstruction: A Prospective, Single-Blinded, Randomized, Controlled Trial

2021 ◽  
Author(s):  
Ronnie L. Shammas ◽  
Caitlin E. Marks ◽  
Gloria Broadwater ◽  
Elliot Le ◽  
Adam D. Glener ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Breast Reconstruction ◽  
Controlled Trial ◽  
Depression Scale ◽  
Control Group ◽  
Lavender Oil ◽  
Entire Cohort ◽  
Randomized Controlled ◽  
Anxiety Depression

Abstract Background Psychosocial distress, depression, or anxiety can occur in up to 50% of women after a breast cancer diagnosis and mastectomy. The purpose of this study was to assess the potential benefit of lavender oil as a perioperative adjunct to improve anxiety, depression, pain, and sleep in women undergoing microvascular breast reconstruction. Methods This was a prospective, single-blinded, randomized, controlled trial of 49 patients undergoing microvascular breast reconstruction. Patients were randomized to receive lavender oil or placebo (coconut oil) throughout their hospitalization. The effect of lavender oil on perioperative stress, anxiety, depression, sleep, and pain was measured using the hospital anxiety and depression scale, Richards–Campbell Sleep Questionnaire, and the visual analogue scale. Results Twenty-seven patients were assigned to the lavender group and 22 patients were assigned to the control group. No significant differences were seen in the perioperative setting between the groups with regard to anxiety (p = 0.82), depression (p = 0.21), sleep (p = 0.86), or pain (p = 0.30) scores. No adverse events (i.e., allergic reaction) were captured, and no significant differences in surgery-related complications were observed. When evaluating the entire cohort, postoperative anxiety scores were significantly lower than preoperative scores (p < 0.001), while depression scores were significantly higher postoperatively as compared with preoperatively (p = 0.005). Conclusion In the setting of microvascular breast reconstruction, lavender oil and aromatherapy had no significant adverse events or complications; however, there were no measurable advantages pertaining to metrics of depression, anxiety, sleep, or pain as compared with the control group.

scholarly journals Long-term outcomes of two-stage, immediate and delayed breast reconstruction with polyurethane-covered versus textured implants: protocol of a prospective, multicentre randomised controlled trial (TIPI trial)

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e044219
Author(s):  
J X Harmeling ◽  
Kevin Peter Cinca ◽  
Eleni-Rosalina Andrinopoulou ◽  
Eveline M L Corten ◽  
M A Mureau
Keyword(s):  
Randomised Controlled Trial ◽  
Breast Reconstruction ◽  
Controlled Trial ◽  
Capsular Contracture ◽  
Tissue Expander ◽  
Complication Rates ◽  
Two Stage ◽  
Randomised Controlled

IntroductionTwo-stage implant-based breast reconstruction is the most commonly performed postmastectomy reconstructive technique. During the first stage, a tissue expander creates a sufficiently large pocket for the definite breast implant placed in the second stage. Capsular contracture is a common long-term complication associated with implant-based breast reconstruction, causing functional complaints and often requiring reoperation. The exact aetiology is still unknown, but a relationship between the outer surface of the implant and the probability of developing capsular contracture has been suggested. The purpose of this study is to determine whether polyurethane-covered implants result in a different capsular contracture rate than textured implants.Methods and analysisThe Textured Implants versus Polyurethane-covered Implants (TIPI) trial is a multicentre randomised controlled trial with a 1:1 allocation rate and a follow-up of 10 years. A total of 321 breasts of female adults undergoing a two-stage breast reconstruction will be enrolled. The primary outcome is capsular contracture at 10-year follow-up which is graded with the modified Baker classification. It is analysed with survival analysis using a frailty model for clustered interval-censored data, with both an intention-to-treat and per-protocol approach. Secondary outcomes are other complication rates, surgical revision rate, patient satisfaction and quality of life and user-friendliness. Outcomes are measured 2 weeks, 6 months, 1, 2, 3, 5 and 10 years postoperatively. Interim analysis is performed when 1-year, 3-year and 5-year follow-up is completed.Ethics and disseminationThe trial has been reviewed and approved by the Medical Research Ethics Committee of the Erasmus MC, University Medical Centre Rotterdam (MEC-2018-126) and locally by each participating centre. Written informed consent will be obtained from each study participant. The results will be disseminated by publication in peer-reviewed journals.Trial registrationNTR7265.

scholarly journals Combined Hip Abductor and External Rotator Strengthening and Hip Internal Rotator Stretching Improves Pain and Function in Patients With Patellofemoral Pain Syndrome: A Randomized Controlled Trial With Crossover Design

2021 ◽  
Vol 9 (4) ◽  
pp. 232596712198972
Author(s):  
Anis Jellad ◽  
Amine Kalai ◽  
Mohamed Guedria ◽  
Mahbouba Jguirim ◽  
Sana Elmhamdi ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Pain Syndrome ◽  
Patellofemoral Pain Syndrome ◽  
Patellofemoral Pain ◽  
Level Of Evidence ◽  
Randomized Controlled ◽  
Group Standard ◽  
Hip Muscle ◽  
And Function

Background: Active rehabilitation has an important role in the management of patellofemoral pain syndrome (PFPS). Although some studies have shown the benefit of hip-muscle strengthening, the effect of combining hip-muscle stretching with strengthening has not yet been defined. Purpose: To evaluate the effect of combined strengthening of the hip external rotators and abductors and stretching of the hip internal rotators on pain and function in patients with PFPS. Study Design: Randomized controlled trial; Level of evidence, 2. Methods: A total of 109 patients with PFPS (75 female and 34 male; mean age, 31.6 ± 10.8 years) were first randomly assigned to protocol A (n = 67) of the A-B arm (AB group; standard rehabilitation) or protocol B (n = 42) of the B-A arm (BA group; standard rehabilitation with strengthening of the hip external rotators and abductors and stretching of the hip internal rotators). Each protocol consisted of 3 sessions a week for 4 weeks. After a washout period, corresponding to a symptom-free period, rehabilitation programs were crossed over. A visual analog scale (VAS) evaluating perceived pain, the Functional Index Questionnaire (FIQ), and the Kujala score were administered at baseline, the end of each rehabilitation protocol, and 12 weeks after the completion of the second protocol for each group. Results: Until the final follow-up, VAS, FIQ, and Kujala scores were significantly improved in both the A-B and B-A arms ( P < .05 for all). Compared with protocol A, protocol B provided significant improvement in terms of pain and function in both the BA (VAS and Kujala; P < .001) and AB (VAS and Kujala; P < .001) groups. Conclusion: Combined strengthening of the hip abductors and external rotators with stretching of the hip internal rotators provided better outcomes, which were maintained for at least 12 weeks, in terms of pain and function in patients with PFPS.

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