Evaluation of safety and efficacy of polyglactin 910 suture in surgical incision closure: clinical study protocol for a randomized controlled trial

Background: Surgical site infection (SSI) occurs in a considerable portion of patients after closure of surgical incision. The newer synthetic absorbable sutures consistently display proven advantages for wound healing over naturally derived suture. The study is planned to evaluate the safety and efficacy of MITSU™ Polyglactin 910 Suture with Coated Vicryl® Polyglactin 910 Suture in a closure of surgical incision.Methods: This is a prospective, multicentric, post-marketing, randomized, controlled, single-blinded, comparative study in a closure of surgical incision where general soft tissue approximation and/or ligation is required during an elective surgery. Patients are randomized to 1:1 ratio in the test (MITSU Polyglactin 910 Suture) and reference (Coated Vicryl Polyglactin 910 Suture) groups. Patients are monitored for safety and efficacy outcomes, viz. the rate of SSI, hospital length of stay, overall wound dehiscence and any adverse events/serious adverse events at post-procedural, 14 days, 30 days and 6 months of surgery. The rate of SSI for each group will be analyzed using one sided T-test. The effect of type of suture on SSI and overall wound dehiscence will be evaluated with chi-square test. Length of stay in hospital will be evaluated with student’s t-test.Conclusions: The study has been designed to compare the safety and efficacy of MITSU Polyglactin 910 Suture versus Coated Vicryl Polyglactin 910 Suture in a closure of surgical incision. Trial registration: The trial protocol has been registered with the clinical trial registry of India (CTRI/2017/01/007717; registered on 17/01/2017).

Gelfoam Embolization - A Preoperative Requisite in Patients with Juvenile Nasopharyngeal Angiofibroma: Report of Three Patients.

We present a case series of three patients who were admitted in the ENT department with the complaints of nasal congestion, nasal bleeding and vertigo. Evaluation of these patients revealed juvenile nasopharyngeal angiofibroma. Patients were advised to undergo excision surgery. We performed preoperative gelfoam embolization in each of these patients to reduce the complications of intraoperative bleeding. All surgeries went well and the blood supply to the area was found to be reinitiated within 5–6 days postoperatively. Here, we highlight the importance of preoperative gelfoam embolization for uneventful surgical excision of juvenile nasopharyngeal angiofibroma.

Interventional Management of High-risk Patients with Takayasu’s Arteritis.

Takayasu’s arteritis is a chronic vasculitis affecting aorta and its branches. We report a case series of Takayasu’s disease. Percutaneous intervention with stent implantation is better choice for stenosis and occlusion of coronary and carotid arteries as well as peripheral lesions, and is increasingly used for the management of Takayasu’s arteritis.

Cardiac Dysfunction in Patients with Sepsis, Severe Sepsis and Septic Shock.

Aims: Patients with severe sepsis and septic shock often exhibit significant cardiovascular dysfunction. We designed the study with an aim to determine the severity of cardiac dysfunction in the different group of sepsis patients. Study Design: Single-center, cross-sectional study Place and Duration of Study: The study was carried out at Department of Cardiology, Kasturba Medical College and Hospital, Manipal from June 2011 to December 2012. Methodology: A total of 74 patients who were diagnosed with sepsis were enrolled in the study. All patients were subjected to routine analysis, laboratory test and echocardiogrphic assessment. Results: The patients were divided into 3 groups: sepsis group (n = 11), severe sepsis group (n =37) and septic shock group (n = 26). The mitral E/A value is significantly higher in patients with septic shock than that of the patients with sepsis (P = 0.04). The indices of right ventricular dysfunction did not show any significant difference in the patients with septic shock and that of sepsis. Conclusion: Left ventricular dysfunction may be considered prevalent in sepsis as per the significant E/A values. However, the other echocardiographic parameter should also be considered. This may even infer that cardiac dysfunction may not correlate with the severity of sepsis.

Endovascular Y-stent Graft Repair of Chronic Contained Ruptured Abdominal Aortic Aneurysm in High-Surgical Risk Patient.

Abdominal aortic aneurysm is a common condition and many a times asymptomatic. The mortality rate is high when it presents with rupture. However, a chronic contained rupture may remain undiagnosed for several weeks to months due to highly variable clinical presentation. Delay in the diagnosis and thereby delay in the treatment lead to worse clinical outcomes in patient experienced chronic contained rupture. We are here presenting a case of an adult patient who experienced rupture of infrarenal aortic aneurysm along with retroperitoneal hematoma. The abdominal aortic aneurysm was diagnosed after several months of rupture as the rupture occurred into the retroperitoneal cavity and remained confined in the retroperitoneal cavity. We successfully treated the patient by deploying a stent percutaneously.