24-Month results of the BRAVO study: A prospective, multi-center study evaluating the clinical outcomes of a ventral hernia cohort treated with OviTex® 1S permanent reinforced tissue matrix.

Background: This study evaluated the performance of OviTex® 1S (TELA Bio Inc., Malvern, PA, USA) over 24 months when used for ventral hernia repair. Methods: This was a prospective, single-arm, multi-center clinical trial (ClinicalTrials.gov/NCT03074474). A ninety-two patient cohort with ventral hernias were enrolled. The surgical approach (open, laparoscopic, or robotic) and plane of placement (retrorectus, intraperitoneal, or pre-peritoneal) were at the discretion of the surgeon. Patients were characterized as high risk for a surgical site occurrence (SSO) based on the following comorbidities: BMI between 30 and 40, active smoker, chronic obstructive pulmonary disease (COPD), diabetes mellitus, coronary artery disease, advanced age ( ≥ 75 years). Subjects underwent physical examinations to evaluate safety events and completed quality of life surveys at 1 months, 3 months, 12 months, and 24 months post-surgery. Results: Sixty-five of the 92 enrolled patients (70.7%) completed 24-month follow-up. The Kaplan Meier estimate for risk of recurrence at day 730 (24 months) was 2.6%; among subjects who completed their 24-month visit or had a previous recurrence, the unadjusted rate of recurrence was 4.5% (3/66). SSOs were observed in 38.0% of patients (35/92). The most prevalent SSO was surgical site infection occurring in 20.7% (19/92) of patients, followed by seroma formation, which occurred in 13.0% of patients; however, only 3.3% required intervention. HerQLes and EQ-5D assessments showed improvement from baseline as soon as 3 months post-surgery. Continued improvement was observed through 24 months. Conclusions: Overall the BRAVO study demonstrates that use of the ovine reinforced tissue matrix OviTex 1S is a viable option for use in ventral hernia repair. Additional studies with longer term follow-up data are needed to draw definitive conclusions on the use of OviTex 1S.

A Prospective, Single Arm, Multi-Center Study Evaluating the Clinical Outcomes of Ventral Hernias Treated with OviTex® 1S Permanent Reinforced Tissue Matrix: The BRAVO Study 12-Month Analysis.

BACKGROUND: Conflicting results from previous studies have led to dissent over whether surgical mesh is safe and effective in ventral hernia repair. A newer class of mesh known as a reinforced tissue matrix, combining a biologic scaffold and minimal polymer reinforcement, offers promise in reducing inflammatory response and increasing abdominal wall support. This study sought to assess the clinical utility of a reinforced tissue matrix (OviTex) in ventral hernia repair 12 months after implantation. METHODS: This is a prospective, single-arm, multi-center study to evaluate the clinical performance of OviTex® 1S Permanent (OviTex) in the repair of primary or recurrent ventral hernias (VH) in consecutive patients (ClinicalTrials.gov/NCT03074474). The rate of surgical site occurrences (SSOs) was evaluated 90 days post-surgery as the primary endpoint. Hernia recurrence and the incidence of postoperative events were evaluated between three and 12 months as secondary endpoints. The incidence of other complications and patient-reported outcomes were also recorded. RESULTS: Ninety-two (92) patients were enrolled in the study, of whom seventy-six (76) reached the 12-month follow-up. All patients were at least 18 years of age with a BMI of <40 kg/m2. Hernia defects were <20 × 20 cm, classified as class I-III according to the CDC wound classification system. Of the 76 patients who reached 12-month follow-up, twenty-six (34%) had previous VH repairs and thirteen (17%) had previous surgical infection. Sixty (79%) had factors known to increase the risk of recurrence. Twenty patients (26%) experienced SSOs, with ten (13%) requiring procedural intervention. Two of the 75 patients (2.7%) experienced a recurrence. CONCLUSIONS: The low rate of hernia recurrence and SSOs requiring intervention illustrates the potential that reinforced tissue matrices, and OviTex 1S, in particular, have to improve outcomes in VH repairs. Follow-up to 24 months is ongoing.

Evaluating the role of postoperative prophylactic antibiotics in primary and secondary breast augmentation: a retrospective review.

BACKGROUND: The use of postoperative prophylactic antibiotics following augmentation mammaplasty remains a controversial topic, with many surgeons opting for extended prophylaxis. OBJECTIVES: The authors evaluate the role of postoperative prophylactic antibiotics in both primary and secondary cosmetic breast augmentation. METHODS: A five-year retrospective chart review was performed on all patients undergoing cosmetic breast augmentation at a single institution from January 2005 to December 2009. The four attending physicians in this study utilized similar perioperative protocol and implant materials. Patients were divided into two cohorts: those who had received three days of postoperative antibiotics (primarily cephalosporins) and those who had not. End points of particular interest included infection, capsular contracture (CC), and local wound complications. The mean follow-up time was 3.8 years. RESULTS: A total of 605 implants were included over the five-year study period. The overall infection rate was 0.66%. For primary augmentation, 493 implants were studied, with 52% of those patients having received postoperative antibiotics. There was no statistically significant reduction in infection, CC, or total complication rate for those receiving postoperative antibiotics. Similarly, 112 implants were studied for secondary augmentation, and again, postoperative antibiotics were not associated with a reduction in complications. CONCLUSIONS: The data suggest that there was no reduction in the overall rate of total complications, infection, or CC with postoperative prophylactic antibiotics for either primary or secondary cosmetic breast augmentation. This study provides Level 3 evidence in support of discontinuing prophylactic postoperative antibiotics following cosmetic breast augmentation.

Reconstruction of complex posterior cervical spine wounds using the paraspinous muscle flap.

BACKGROUND: The paraspinous muscle flap is often overlooked for use in cervical wounds, as surgeons cite the decreased size and mobility of the muscles in the cervical region. The purpose of this article is to introduce the paraspinous muscle flap technique for reconstruction of cervical spine wounds. METHODS: An 11-year, single-institution, retrospective chart review was performed on 14 consecutive patients from 1996 to 2007. All patients underwent paraspinous muscle flap surgery to provide soft-tissue coverage of the cervical spine following wound healing complications resulting in exposed hardware or bone. Variables of interest included demographics, comorbidities, and postreconstruction wound healing complications. RESULTS: The overall complication rate after paraspinous muscle flap surgery was low [two of 14 (14 percent)] and consisted of two minor wound infections. There was no postreconstruction seroma, a well-known complication of the trapezius muscle flap, which is often thought of as the first-line option for posterior cervical soft-tissue reconstruction. CONCLUSION: The paraspinous muscle flap is an expeditious and reliable solution to complex cervical spine wounds. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.(Figure is included in full-text article.).

The use of Permacol® for chest wall reconstruction in a case of desmoid tumour resection.

Desmoid tumour resection is a known, albeit rare, cause for chest wall reconstruction. Traditionally, musculocutaneous flaps and synthetic mesh materials have been employed for coverage over these potentially large thoracic defects. More recently, biologic mesh materials have become increasingly more prevalent in a multitude of surgical reconstructions. To date, the current literature describes the usage of select biologic materials, such as human cadaveric acellular dermal matrix, in chest wall reconstruction. One variation of the biologic materials, Permacol(®), has not been well described in the literature for chest wall reconstruction. Permacol(®) is a porcine lyophilised acellular dermal collagen. We report the successful use of Permacol(®) in a complex chest wall reconstruction following the resection of a large desmoid tumour.

Paraspinous muscle flap reconstruction of complex midline back wounds: Risk factors and postreconstruction complications.

With increasingly complex spine surgeries now being performed on a more comorbid patient population, the reconstruction of midline back wounds from these procedures is becoming a frequent dilemma encountered by plastic surgery. The purpose of this study is to examine the effect of various preoperative risk factors on postoperative wound healing complications after paraspinous muscle flap reconstruction of midline back defects. An Institutional Review Board-approved, 11-year, retrospective, office and hospital chart review was conducted. All adult patients who underwent paraspinous muscle flap reconstruction during the study period were included. There were 92 patients in the study, representing the largest reported series to-date for the paraspinous muscle flap procedure. Mean follow-up was 120 days. Several wound-healing risk factors were present in this patient population: 72% were malnourished, 41% had hypertension, 37% were obese, 34% had a history of smoking, 32% had diabetes, 16% were on chronic steroids, 14% had a history of more than 2 previous spine surgeries, and 9% had a history of radiation to the wound area. Factors significantly (P < 0.05) associated with postreconstruction wound complications included history of traumatic spine injury, prereconstruction hardware removal, a history of more than 2 spine surgeries, hypertension, and lumbar wound location. This patient population possesses multiple comorbidities making complex wound healing difficult. Several specific risk factors are associated with an increased rate of postreconstruction wound complications after paraspinous muscle flaps. The paraspinous muscle flap remains an important tool for spinal wound reconstruction in the reconstructive surgeon's armamentarium.

Synthetic and biological mesh in component separation: a 10-year single institution review.

Definitive repair of recurrent ventral hernias using abdominal wall reconstruction techniques is an essential tool in the armentarium for general and plastic surgeons. Despite the great morbidity associated with incisional hernia, no consensus exists on the best means for treatment (Korenkov et al, Langenbecks Arch Surg. 2001;386:65-73). Ramirez et al (Plast Reconstr Surg. 1990;83:519-526) describes the "component separation" technique to mobilize the rectus-abdominus internal oblique and external oblique flap to correct the defect. This retrospective institutional study reviewed 10 years of myofascial flap reconstruction from 1996 to 2006 at Thomas Jefferson University Hospital and revealed an 18.3% recurrence rate in 545 component separations. We identified obesity (body mass index >30 kg/m2), age >65 years old, male gender, postoperative seroma, and preoperative infection as risk factors for hernia recurrence.

Technical changes in paraspinous muscle flap surgery have increased salvage rates of infected spinal wounds.

OBJECTIVES: The objective of this study is to introduce modifications in paraspinous muscle flap surgery and compare this new variation's ability to salvage infected hardware with the classic technique. Infected posterior spine wounds are a difficult problem for reconstructive surgeons. As per experience, hardware retention in infected wounds maintains spinal stability, decreases length of stay, and decreases the wound healing complication rate. METHODS: An 11-year retrospective office and hospital chart review was conducted between July 1996 and August 2007. All patients who underwent paraspinous muscle flap reconstruction for postspine surgery wound infections during this time period were included. There were 51 patients in the study representing the largest reported series, to date, for this procedure. Twenty-two patients underwent treatment using the modified technique and 29 patients were treated using the classic technique. RESULTS: There was no statistical difference between the 2 groups in demographics, medical history, or reason for initial spine surgery. The hardware salvage rate associated with the modified technique was greater than the rate associated with the classic technique (95.4% vs 75.8%; P = .03). There were fewer postreconstruction wound healing complications requiring hospital readmission in the modified technique group than the classic group (13.6% vs 44.8%; P = .04). Patients in the modified technique group demonstrated a shorter mean length of stay than the patients in the classic group (23.7 days vs 29.7; P = .25). CONCLUSIONS: The modified paraspinous muscle flap technique is an excellent option for spinal wound reconstruction, preservation of spinal hardware, and local infection control.

Pregnancy following homologous prepubertal ovarian transplantation in the dog.

In several canine models of hereditary human disease the homozygote dogs die prior to puberty, or have substantially reduced fertility. To create a clinically healthy animal that can be bred, but can also transmit the gene of interest, a model of homologous ovarian transplantation in prepubertal dogs was developed. Six dog leukocyte antigen (DLA) identical littermates underwent transplantation of ovarian cortical strips (n = 2) or the entire ovary (n = 4). Immunosuppression was maintained with cyclosporine and MMF in the immediate post-operative period and cyclosporine alone thereafter. All 6 dogs entered puberty and normal semiannual estrus cycles as demonstrated by both physical changes and increasing serum progesterone. Four dogs were bred to a proven stud male, and one became pregnant. Three viable fetuses with observable heart-beats were detected on ultrasound examination. Although the dog eventually aborted the litter, this work represents the first pregnancy achieved following a prepubertal ovarian transplant in the dog.