Acellular Dermal Matrix Sterility: Does It Affect Microbial and Clinical Outcomes Following Implantation?

The use of acellular dermal matrices (ADMs) in breast reconstruction is a controversial topic. Recent literature has investigated the effects of ADM sterilization on infectious complications, although with varying conclusions. Previous work by our group showed no difference between aseptic and sterilized products immediately out of the package. In this study, we investigate the microbiologic profiles of these agents after implantation. METHODS: In this prospective study, we cultured samples of ADM previously implanted during the first stage of tissue expander-based immediate breast reconstruction. A 1 cm2 sample was excised during the stage II expander-implant exchange procedure, and samples were incubated for 48 hours in tryptic soy broth. Samples with growth were further cultured on tryptic soy broth and blood agar plates. Patient records were also analyzed, to determine if ADM sterilization and microbial growth were correlated with infectious complications. RESULTS: In total, 51 samples of ADM were collected from 32 patients. Six samples were from aseptic ADM (AlloDerm), 27 samples were from ADM sterilized to 10-3 (AlloDerm Ready-to-Use), and 18 samples were from products sterilized to 10-6 (AlloMax). No samples demonstrated bacterial growth. Only 5 patients experienced postoperative complications, of whom only 1 patient was infectious in nature. We failed to demonstrate a statistically significant correlation between sterility and postoperative complications. CONCLUSIONS: Our findings showed no difference in microbial presence and clinical outcomes when comparing ADM sterility. Furthermore, no samples demonstrated growth in culture. Our study brings into question the necessity for terminal sterilization in these products.

Are Prophylactic Postoperative Antibiotics Necessary for Immediate Breast Reconstruction? Results of a Prospective Randomized Clinical Trial.

BACKGROUND: Closed-suction drains, implants, and acellular dermal matrix (ADM) are routinely used in tissue expander-based immediate breast reconstruction (TE-IBR). Each of these factors is thought to increase the potential for surgical site infection (SSI). Although CDC guidelines recommend only 24 hours of antibiotic prophylaxis after TE-IBR, current clinical practices vary significantly. This study evaluated the difference in SSI between 2 different prophylactic antibiotic durations. STUDY DESIGN: A noninferiority randomized controlled trial was designed in which TE-IBR patients received antibiotics either 24 hours postoperatively or until drain removal. The primary outcome was SSI, as defined by CDC criteria. Operative and postoperative protocols were standardized. Secondary endpoints included clinical outcomes up to 1 year and all implant loss, or reoperation. RESULTS: There were 112 TE-IBR patients (180 breasts) using ADM who were randomized into 2 study arms, with 62 patients in the 24-hour group and 50 in the extended group. Surgical site infection was diagnosed in 12 patients in the 24-hour group and 11 in the extended group (19.4% vs 22.0%, p = 0.82). The extended group had 7 patients who required IV antibiotics and an overall implant loss in 7 patients (14.0%). The 24-hour group had 4 patients who required IV antibiotics, with 3 requiring removal (4.8%). Patients with diabetes, postoperative seroma, or wound dehiscence were all more likely to develop SSI (p < 0.02). CONCLUSIONS: In a randomized controlled noninferiority trial, 24 hours of antibiotics is equivalent to extended oral antibiotics for SSI in TE-IBR patients. Additional multicenter trials will further assess this important aspect of TE-IBR postoperative care.

Creation of gastric conduit free-graft with intraoperative perfusion imaging during pancreaticoduodenectomy in a patient post esophagectomy.

As surgery becomes more successful for complicated malignancies, patients survive longer and can unfortunately develop subsequent malignancies. Surgical resection in these settings can be treacherous and manipulations of the patient's anatomy need to be closely considered before embarking on major operations. We report a case of a patient who survived esophageal resection for locally advanced esophageal cancer only to develop a new pancreatic head malignancy. Careful upfront planning allowed for a successful resection with an uncomplicated recovery. She underwent open pancreaticoduodenectomy, and to maintain perfusion to the gastric conduit a microvascular anastomosis of the gastroepiploic pedicle was performed to the middle colic vessels. Intraoperative fluorescent imaging was used to evaluate the anastomosis as well as gastric and duodenal perfusion during the case.

Resource cost comparison of implant-based breast reconstruction versus TRAM flap breast reconstruction.

Relatively little has been published to date comparing the resource costs of transverse rectus abdominis musculocutaneous (TRAM) flap and prosthetic breast reconstruction. The data that have been published reflect the experience at just one medical center with a previously known clear preference for autologous breast reconstruction. The goal of this study was to compare the resource costs of TRAM flap and prosthetic reconstruction in an institution where both procedures continue to be performed using modern techniques and at a relatively equivalent frequency. All available medical records were reviewed for patients who had completed their breast reconstruction between 1987 and 1997. Records of patients who had undergone TRAM flap or prosthetic reconstruction were reviewed to compare resource costs, including hospital stay, operating room time, anesthesia time, prosthetic devices, and physician's fees. Of 835 patients reviewed who had completed breast reconstruction, a total of 140 suitable patients were identified who had all the necessary financial information available. The patient population comprised 64 patients who received TRAM flaps and 76 patients who had undergone prosthetic reconstruction. The length of stay for the TRAM flap group, including all subsequent admissions for each patient, ranged from 2 to 24 days (mean, 6.25 days), and that for the prosthetic reconstruction group ranged from 0 to 20 days (mean, 4.36 days). Operating room time for the complete multistage reconstructive process for a TRAM flap ranged from 5 hours, 20 minutes to 12 hours, 25 minutes (mean, 7 hours, 34 minutes); with implant-based reconstruction, operating time ranged from 1 hour, 45 minutes to 8 hours, 56 minutes (mean, 4 hours, 6 minutes). With prostheses costing from $600 to $1200, a surgeon's fee of $160/hour, and an assistant's fee of $45/hour, the average cost of TRAM flap reconstructions was $19,607 (range, $11,948 to $49,402), compared with $15,497 for prosthetic reconstructions (range, $6422 to $40,015). The results were statistically significant (p < 0.001). Several factors weigh into the decision as to which reconstructive operation best suits the patient's needs. These factors include surgical risk, potential morbidity, and aesthetic results. On the basis of this review of autologous and prosthetic breast reconstruction in an institution where both are performed frequently, during a 10-year period with a mean time elapsed since reconstruction of 7.45 years, prosthetic reconstruction was significantly less expensive.

Vascularized rib for facial reconstruction.

The reconstruction of maxillectomy defects is a complex problem encountered in plastic surgery. Defects can range in size and complexity from small defects requiring only soft tissue to complete maxillectomies requiring large tissue bulk, bone, and one or more skin paddles. The most difficult defects involve the skull base and orbit. The reconstructive surgeon is faced with the challenge of isolating the nasopharynx from the dura and globe while simultaneously restoring the bony framework of the maxilla and orbit to support the soft tissue of the cheek. The authors present a series of six reconstructions using a rectus abdominis muscle flap with associated vascularized rib for reconstruction of complex maxillectomy defects. This flap provides large soft-tissue bulk as well as bony support and a long vascular pedicle. A skin island can be taken with the flap, and the donor-site morbidity is comparable to that seen with a vertical rectus abdominis myocutaneous flap. Six flaps were used in five patients over a 20-month period. All patients had stable support of the orbit at follow-up with adequate soft-tissue coverage, and there were no incidences of visual changes.

The correction of capsular contracture by conversion to "dual-plane" positioning: technique and outcomes.

Little has been published regarding the treatment of patients with long-established capsular contracture after previous submuscular or subglandular breast augmentation. This study reviews 7 years of experience in treating established capsular contracture after augmentation mammaplasty by relocating implants to the "dual-plane" or partly subpectoral position. A retrospective chart review was performed on all patients who were treated for capsular contracture using this technique between 1993 and 1999. Data collected included the date of the original augmentation, the original implant location, date of revision and type of implant used, length of follow-up, outcome, and any ensuing complications. Different surgical techniques were used, depending on whether the prior implant was located in a subglandular or submuscular plane. All patients had revisions such that their implants were relocated to a dual plane, with the superior two thirds or so of the implant located beneath the pectoralis major muscle and the inferior one third located subglandularly. Of 85 patients reviewed, 54 had their original implants in a submuscular position and 31 had their initial augmentation in a subglandular position. Of the 54 patients whose implants were initially submuscular, 23 patients (43 percent) had silicone gel implants, 15 patients (28 percent) had double-lumen implants, and the remaining 16 patients (30 percent) had saline implants. Of the 31 patients whose implants were initially subglandular, 20 patients (65 percent) had silicone gel implants, three patients (10 percent) had double-lumen implants, and the remaining eight patients (26 percent) had saline implants. Fifty-one patients (60 percent) had replacement with saline implants (37 smooth saline, 14 textured saline), whereas 34 (40 percent) had silicone gel implants (seven smooth gel, 27 textured gel). The average time from previous augmentation to revision was 9 years 9 months. The average follow-up time after conversion to the dual-plane position was 11.5 months. Only three of 85 patients required reoperation for complications, all of which involved some degree of implant malposition. Of patients converted to the dual plane, 98 percent were free of capsular contracture and were Baker class I at follow-up, whereas 2 percent were judged as Baker class II. There were no Baker level III or IV contractures at follow-up. The dual-plane method of breast augmentation has proved to be an effective technique for correcting established capsular contracture after previous augmentation mammaplasty. This technique appears to be effective when performed with either silicone or saline-filled implants.

Comparing quantitative values of two generations of laser-assisted indocyanine green dye angiography systems: can we predict necrosis?

OBJECTIVE: Several devices exist today to assist the intraoperative determination of skin flap perfusion. Laser-Assisted Indocyanine Green Dye Angiography (LAICGA) has been shown to accurately predict mastectomy skin flap necrosis using quantitative perfusion values. The laser properties of the latest LAICGA device (SPY Elite) differ significantly from its predecessor system (SPY 2001), preventing direct translation of previous published data. The purpose of this study was to establish a mathematical relationship of perfusion values between these 2 devices. METHODS: Breast reconstruction patients were prospectively enrolled into a clinical trial where skin flap evaluation and excision was based on quantitative SPY Q values previously established in the literature. Initial study patients underwent mastectomy skin flap evaluation using both SPY systems simultaneously. Absolute perfusion unit (APU) values at identical locations on the breast were then compared graphically. RESULTS: 210 data points were identified on the same patients (n = 4) using both SPY systems. A linear relationship (y = 2.9883x + 12.726) was identified with a high level or correlation (R(2) = 0.744). Previously published values using SPY 2001 (APU 3.7) provided a value of 23.8 APU on the SPY Elite. In addition, postoperative necrosis in these patients correlated to regions of skin identified with the SPY Elite with APU less than 23.8. CONCLUSION: Intraoperative comparison of LAICGA systems has provided direct correlation of perfusion values predictive of necrosis that were previously established in the literature. An APU value of 3.7 from the SPY 2001 correlates to a SPY Elite APU value of 23.8.

Intraoperative perfusion techniques can accurately predict mastectomy skin flap necrosis in breast reconstruction: results of a prospective trial.

BACKGROUND: Intraoperative vascular imaging can assist assessment of mastectomy skin flap perfusion to predict areas of necrosis. No head-to-head study has compared modalities such as laser-assisted indocyanine green dye angiography and fluorescein dye angiography with clinical assessment. METHODS: The authors conducted a prospective clinical trial of tissue expander-implant breast reconstruction with intraoperative evaluation of mastectomy skin flaps by clinical assessment, laser-assisted indocyanine green dye angiography, and fluorescein dye angiography. Intraoperatively predicted regions of necrosis were photographically documented, and clinical assessment guided excision. Postoperative necrosis was directly compared with each prediction. The primary outcome was all-inclusive skin necrosis. RESULTS: Fifty-one tissue expander-implant breast reconstructions (32 patients) were completed, with 21 cases of all-inclusive necrosis (41.2 percent). Laser-assisted indocyanine green dye angiography and fluorescein dye angiography correctly predicted necrosis in 19 of 21 of cases where clinical judgment had failed. Only six of 21 cases were full-thickness necrosis, and five of 21 required an intervention (9.8 percent). Risk factors such as smoking, obesity, and breast weight greater than 1000 g were statistically significant. Laser-assisted indocyanine green dye angiography and fluorescein dye angiography overpredicted areas of necrosis by 72 percent and 88 percent (p = 0.002). Quantitative analysis for laser-assisted indocyanine green dye angiography in necrotic regions showed absolute perfusion units less than 3.7, with 90 percent sensitivity and 100 percent specificity. CONCLUSIONS: Laser-assisted indocyanine green dye angiography is a better predictor of mastectomy skin flap necrosis than fluorescein dye angiography and clinical judgment. Both methods overpredict without quantitative analysis. Laser-assisted indocyanine green dye angiography is more specific and correlates better with the criterion standard diagnosis of necrosis. CLINICAL QUESTION/LEVEL OF EVIDENCE: Diagnostic, I.

The correction of capsular contracture by conversion to "dual-plane" positioning: technique and outcomes.

Little has been published regarding the treatment of patients with long-established capsular contracture after previous submuscular or subglandular breast augmentation. This study reviews 7 years of experience in treating established capsular contracture after augmentation mammaplasty by relocating implants to the "dual-plane" or partly subpectoral position. A retrospective chart review was performed on all patients who were treated for capsular contracture using this technique between 1993 and 1999. Data collected included the date of the original augmentation, the original implant location, date of revision and type of implant used, length of follow-up, outcome, and any ensuing complications. Different surgical techniques were used, depending on whether the prior implant was located in a subglandular or submuscular plane. All patients had revisions such that their implants were relocated to a dual plane, with the superior two thirds or so of the implant located beneath the pectoralis major muscle and the inferior one third located subglandularly. Of 85 patients reviewed, 54 had their original implants in a submuscular position and 31 had their initial augmentation in a subglandular position. Of the 54 patients whose implants were initially submuscular, 23 patients (43 percent) had silicone gel implants, 15 patients (28 percent) had double-lumen implants, and the remaining 16 patients (30 percent) had saline implants. Of the 31 patients whose implants were initially subglandular, 20 patients (65 percent) had silicone gel implants, three patients (10 percent) had double-lumen implants, and the remaining eight patients (26 percent) had saline implants. Fifty-one patients (60 percent) had replacement with saline implants (37 smooth saline, 14 textured saline), whereas 34 (40 percent) had silicone gel implants (seven smooth gel, 27 textured gel). The average time from previous augmentation to revision was 9 years 9 months. The average follow-up time after conversion to the dual-plane position was 11.5 months. Only three of 85 patients required reoperation for complications, all of which involved some degree of implant malposition. Of patients converted to the dual plane, 98 percent were free of capsular contracture and were Baker class I at follow-up, whereas 2 percent were judged as Baker class II. There were no Baker level III or IV contractures at follow-up. The dual-plane method of breast augmentation has proved to be an effective technique for correcting established capsular contracture after previous augmentation mammaplasty. This technique appears to be effective when performed with either silicone or saline-filled implants.

TRAM flap breast reconstruction after abdominal liposuction.

The transverse rectus abdominis musculocutaneous (TRAM) flap has become the gold standard of autologous breast reconstruction. It is typically a low-risk procedure with few surgical contraindications. A relative contraindication, however, is prior liposuction of the abdomen. The contention has been that the trauma of the liposuction procedure can damage or destroy the musculocutaneous perforators that supply circulation to the TRAM flap skin paddle. The authors present 2 patients who previously underwent suction-assisted abdominal lipectomy and, after mastectomies, successfully underwent unilateral breast reconstruction using single-pedicle TRAM flaps. They also examine the literature that supports the feasibility of this procedure.