Clinical Research Directory

Prineo Sensitivity Dressing Study

Wound complications can be devastating following total joint arthroplasty, resulting in an increased practice burden in the form of more frequent follow ups, increased clinic visits potential for wound dehiscence, superficial infection and deep infection with possible return to the operating room and revision surgery. Several dressing options are currently on the market designed to minimize wound complications in addition to traditional dressings, including negative pressure dressing, antimicrobial dressing, occlusive dressings, and/or skin adhesives. Prineo dressing (2-octyl cyanoacrylate adhesive (Dermabond) and n-butyl-2-cyanoacrylate adhesive) has increased in popularity as a dressing option used by joint arthroplasty surgeons. There is a well-documented adverse allergic response with these dressings resulting in peri-incisional erythema, urticaria, and/or an eczematous skin reaction. Recently, Mayman et al reported a rate of 1-1.5%, suggesting a possible rising incidence of ACD attributable to increased utilization of the specific dressing and sensitization. To our knowledge, no prospective trial has compared the rates of adverse allergic reactions in Prineo naive patients to patients who have undergone previous total joint arthroplasty (TJA) and received Prineo dressings in the past. The study team will utilize a prospective controlled study design to assess the rate of adverse allergic reactions in patients naive to Prineo versus those with previous exposure. The study team will assess rates of allergic reactions at one week post-op and at their first post-op clinic visit, 2 to 3 weeks post-op, tracking rates of allergic reactions as well as severity, the use of post-operative antibiotics, work up for prosthetic joint infection, return to the operating room, surgical site infection, confirmed prosthetic joint infection and stiffness requiring manipulation under anesthesia.

Nickel Sensitivity

The purpose of this study is to compare clinical outcomes of patients with self reported nickel sensitivity undergoing primary total knee arthroplasty (TKA) with conventional, standard-of-care vs nickel-free implants. The hypothesis is that patients with a self-reported nickel sensitivity will have similar patient reported outcome scores compared to those patients without reported nickel sensitivity. Therefor the anticipation is for there to be no differences in other clinical outcome measures or functional outcome scores between the two cohorts.

Human Seminal Plasma Allergy: Quality of Life

Human Seminal Plasma Allergy (HSPA) is a rare allergy with localized and/or generalized manifestations following exposure during unprotected sex. Its cause remains undetermined and is certainly underdiagnosed. It is an under-recognized cause of acute or chronic pain related to penetration and vaginal inflammation affecting sexually active women. To date, no quality-of-life questionnaire specific to this condition exists to demonstrate its impact on the physical, mental, and sexual health of patients. To try to highlight the suffering of these patients, non-specific sexual quality-of-life questionnaires exist and could be used, such as the "Female Sexual Function Index" (including questions on desire, arousal, and the ability to reach orgasm), but these do not address the sexual impact of psychological distress related to any pathology and do not assess the impact of HSPA-specific symptoms on sexuality. The symptoms of endometriosis can be compared to those of patients with HSPA due to chronic abdominopelvic pain that worsens during sexual intercourse, the psychological impact, and the potential effect on fertility. A specific questionnaire exists for patients with endometriosis that documents these commonalities: the EHP-30. It is recognized as a specific and sensitive tool for measuring the quality of life of women with endometriosis in routine clinical practice. However, the EHP-30 questionnaire focuses on symptoms that are often chronic and persistent, even outside of sexual intercourse, whereas HSPA is characterized by acute episodes, sometimes spaced out and dependent on exposure to seminal fluid, making the tool less relevant for assessing the quality of life of patients with HSPA. This study aims to evaluate and compare the measurement of quality of life in patients with HSPA using these different tools and a specific general question in order to describe quality of life in this population. This will also provide evidence to question the value of creating a questionnaire specific to the pathology.

Quercus Ilex and Quercus Robur Allergen Extracts Standardisation

The objective of this study is to determine the biological activity of Quercus illex and Quercus robur allergen extracts in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).