Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06011603
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2023-08-21
Brief Title:
Prineo Sensitivity Dressing Study
Sponsor:
Rush University Medical Center
Organization:
Rush University Medical Center
Study Overview
Official Title:
Prospective Evaluation of Type IV Hypersensitivity Reactions After Prineo Dressing Application in Partial and Total Joint Arthroplasty Patients
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 andor 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 andor an eczematous skin reaction Recently Mayman et al reported a rate of 1-15 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
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
Detailed Description:
Level I Prospective Cohort Study
Patients will be recruited into the study after completing a standard questionnaire for pre-operative enrollment After meeting inclusion criteria and passing the screening process the patient will be enrolled into the study Variables of interest related to sociodemographic status operative details and postoperative outcomes will be taken from the electronic medical records associated with Midwest Orthopedics at Rush and Rush University Medical Center will be performed This review will comprise patients of multiple providers at Midwest Orthopedics at Rush including Dr Vasili Karas Dr Richard Berger and Dr Brett Levine Relevant variables that will be collected include
Inclusion Criteria
1 Patients older than 18 years that underwent primary total hip arthroplasty THA
2 Patients older than 18 years that underwent primary total or unicompartmental knee arthroplasty TKAUKA
Exclusion Criteria
1 Revision surgery
2 Prior history of allergic contact dermatitis
3 Occupational exposure to glues and surgical dressing
4 Prior operative procedure non-TJA with use of Prineo dressing
Sample Size
A power analysis to determine how many patients need to be enrolled was performed with a rate of ACD in the surgical dressing naïve group and the surgical dressing-exposed group of 1 and 2 respectively A one-tailed z-test of proportions between the two groups with 80 power a 5 level of significance and 11 allocation ratio requires a sample size of 314 157 per group To account for 20 attrition rate amongst both cohorts The study team plan to enroll 400 patients 200 each group
DemographicPatient Specific Data Collected
Age Sex Body Mass Index BMI Allergy History Past Surgical History Prior exposure to gluemesh dressing Either occupational ie healthcare worker or as a patient Number of prior arthroplasty surgeries with Prineo dressing ie 0 1 2 3 Past adverse reaction to Prineo dressing Any Adverse Skin Reactions with any past adhesive exposure
Operative details
Surgical date OperationLaterality THATKAUKA LeftRight Length of incision Patient reported skin check at 1 week via picture from patient if wound issueskin reaction present Size of Rash if present Provider skin Check at 1st post-operative appointment 2-4 weeks post-op Any Wound Complications
Primary Outcome Measure
The primary outcome is the rate of contact allergic dermatitis or adverse skin reaction at 1 week post op and 1st post operative visit 2-3 weeks after surgery The study team will also quantify time from surgery to reaction onset Days The study team will measure the size of the rash at post-operative follow up as well as classify the rash according to the classification system used in prior studies examining Prineo-related ACD9
Classification of 2-Octyl Cyanoacrylate Reactions12
Mild
Erythema infiltration possible papules
Moderate
Erythema infiltration papules and vesicles
Severe
Spreading reaction outside area of application bullous reaction extreme pruritus
Secondary Outcome Measures
Wound complications Any workup for PJI Serologic labs ESRCRP arthrocentesis Any administration of post-operative antibiotics outside of normal protocol Return to Operating Room for debridement manipulation other surgical interventions Surgical Site Infection SSI Confirmed Periprosthetic Joint Infection PJI Stiffness requiring Manipulation Under Anesthesia MUA
Patient Enrollment
Patients will be enrolled from the clinics of the surgeons in the division of Hip and Knee Replacement at Midwest Orthopaedics at Rush These surgeons include Dr Brett Levine Dr Vasili Karas and Dr Richard Berger The clinical research coordinator will screen each surgeonsupcoming surgical schedule two weeks in advance Patients undergoing primary TJA at Rush University Medical Center meeting the inclusion and exclusion criteria will be contacted via telephone or in clinic and will be explained the purposes of this investigation If the patient is willing to participate they will give verbal consent prior to the day of their surgical procedure Informed consent will be obtained by either the clinical research coordinator or physician on the surgical team
Informed Consent
The study staff will review the informed consent document and study requirements with the patient and answer any questions the patient may have over the telephone or in a private clinic area The patient will have the opportunity to review the information packet and do hisher own research on the topic if desired Once all of the patients questions have been answered and if the patient has given verbal consent heshe will be enrolled in the study
Sample Size A power analysis has been completed using allergic reaction as the primary endpoint This analysis was based on an investigation by Mayman et al 9 that demonstrated a wound complication rate of 1 in the TJA setting using Prineo dressings The study team feel an increase in allergic reaction from 1 in Prineo naive patients to 2 in patients with previous Prineo use will be clinically significant Therefore 200 patients per treatment group will provide an overall type 1 error rate alpha of 005 and power of at least 80 Our institution serves as a major referral center in the region for total joint arthroplasty and the study team perform over hundreds of primary total joint replacements annually Therefore the study team believe the required sample size can be achieved in approximately one year
Patients will be recruited into the study after completing a standard questionnaire for pre-operative enrollment After meeting inclusion criteria and passing the screening process the patient will be enrolled into the study Variables of interest related to sociodemographic status operative details and postoperative outcomes will be taken from the electronic medical records associated with Midwest Orthopedics at Rush and Rush University Medical Center will be performed This review will comprise patients of multiple providers at Midwest Orthopedics at Rush including Dr Vasili Karas Dr Richard Berger and Dr Brett Levine Relevant variables that will be collected include
Inclusion Criteria
1 Patients older than 18 years that underwent primary total hip arthroplasty THA
2 Patients older than 18 years that underwent primary total or unicompartmental knee arthroplasty TKAUKA
Exclusion Criteria
1 Revision surgery
2 Prior history of allergic contact dermatitis
3 Occupational exposure to glues and surgical dressing
4 Prior operative procedure non-TJA with use of Prineo dressing
Sample Size
A power analysis to determine how many patients need to be enrolled was performed with a rate of ACD in the surgical dressing naïve group and the surgical dressing-exposed group of 1 and 2 respectively A one-tailed z-test of proportions between the two groups with 80 power a 5 level of significance and 11 allocation ratio requires a sample size of 314 157 per group To account for 20 attrition rate amongst both cohorts The study team plan to enroll 400 patients 200 each group
DemographicPatient Specific Data Collected
Age Sex Body Mass Index BMI Allergy History Past Surgical History Prior exposure to gluemesh dressing Either occupational ie healthcare worker or as a patient Number of prior arthroplasty surgeries with Prineo dressing ie 0 1 2 3 Past adverse reaction to Prineo dressing Any Adverse Skin Reactions with any past adhesive exposure
Operative details
Surgical date OperationLaterality THATKAUKA LeftRight Length of incision Patient reported skin check at 1 week via picture from patient if wound issueskin reaction present Size of Rash if present Provider skin Check at 1st post-operative appointment 2-4 weeks post-op Any Wound Complications
Primary Outcome Measure
The primary outcome is the rate of contact allergic dermatitis or adverse skin reaction at 1 week post op and 1st post operative visit 2-3 weeks after surgery The study team will also quantify time from surgery to reaction onset Days The study team will measure the size of the rash at post-operative follow up as well as classify the rash according to the classification system used in prior studies examining Prineo-related ACD9
Classification of 2-Octyl Cyanoacrylate Reactions12
Mild
Erythema infiltration possible papules
Moderate
Erythema infiltration papules and vesicles
Severe
Spreading reaction outside area of application bullous reaction extreme pruritus
Secondary Outcome Measures
Wound complications Any workup for PJI Serologic labs ESRCRP arthrocentesis Any administration of post-operative antibiotics outside of normal protocol Return to Operating Room for debridement manipulation other surgical interventions Surgical Site Infection SSI Confirmed Periprosthetic Joint Infection PJI Stiffness requiring Manipulation Under Anesthesia MUA
Patient Enrollment
Patients will be enrolled from the clinics of the surgeons in the division of Hip and Knee Replacement at Midwest Orthopaedics at Rush These surgeons include Dr Brett Levine Dr Vasili Karas and Dr Richard Berger The clinical research coordinator will screen each surgeonsupcoming surgical schedule two weeks in advance Patients undergoing primary TJA at Rush University Medical Center meeting the inclusion and exclusion criteria will be contacted via telephone or in clinic and will be explained the purposes of this investigation If the patient is willing to participate they will give verbal consent prior to the day of their surgical procedure Informed consent will be obtained by either the clinical research coordinator or physician on the surgical team
Informed Consent
The study staff will review the informed consent document and study requirements with the patient and answer any questions the patient may have over the telephone or in a private clinic area The patient will have the opportunity to review the information packet and do hisher own research on the topic if desired Once all of the patients questions have been answered and if the patient has given verbal consent heshe will be enrolled in the study
Sample Size A power analysis has been completed using allergic reaction as the primary endpoint This analysis was based on an investigation by Mayman et al 9 that demonstrated a wound complication rate of 1 in the TJA setting using Prineo dressings The study team feel an increase in allergic reaction from 1 in Prineo naive patients to 2 in patients with previous Prineo use will be clinically significant Therefore 200 patients per treatment group will provide an overall type 1 error rate alpha of 005 and power of at least 80 Our institution serves as a major referral center in the region for total joint arthroplasty and the study team perform over hundreds of primary total joint replacements annually Therefore the study team believe the required sample size can be achieved in approximately one year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None