Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06011629
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2023-08-21
Brief Title:
Aquacel Hypersensitivity Dressing in TJAs
Sponsor:
Rush University Medical Center
Organization:
Rush University Medical Center
Study Overview
Official Title:
Prospective Evaluation of Type IV Hypersensitivity Reactions After Aquacel 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:
The aim of this multi-surgeon single institution study is to prospectively evaluate the incidence of allergic contact dermatitis ACD following application of AQUACEL Ag a silver-containing hydrofiber dressing in total hip and knee arthroplasty patients Arthroplasty-naïve patients will be compared to prior total joint arthroplasty patients who received a Aquacel dressing postoperatively
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
Sample Size
A power analysis to determine how many patients need to be enrolled was performed with a rate of ACD in the AQUACEL Ag naïve group and the AQAUCEL Ag-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 we 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 surgical dressing Either occupational ie healthcare worker or as a patient Number of prior arthroplasty surgeries with AQUACEL Ag dressing ie 0 1 2 3 Past adverse reaction to AQUACEL Ag 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 We will also quantify time from surgery to reaction onset Days We 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 ACD
Secondary Outcome Measures
1 Wound complications
2 Any workup for PJI Serologic labs ESRCRP arthrocentesis
3 Any administration of post-operative antibiotics outside of normal protocol
4 Return to Operating Room for debridement manipulation other surgical interventions
5 Surgical Site Infection SSI
6 Confirmed Periprosthetic Joint Infection PJI
7 Stiffness requiring Manipulation Under Anesthesia MUA
Sample Size
A power analysis to determine how many patients need to be enrolled was performed with a rate of ACD in the AQUACEL Ag naïve group and the AQAUCEL Ag-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 we 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 surgical dressing Either occupational ie healthcare worker or as a patient Number of prior arthroplasty surgeries with AQUACEL Ag dressing ie 0 1 2 3 Past adverse reaction to AQUACEL Ag 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 We will also quantify time from surgery to reaction onset Days We 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 ACD
Secondary Outcome Measures
1 Wound complications
2 Any workup for PJI Serologic labs ESRCRP arthrocentesis
3 Any administration of post-operative antibiotics outside of normal protocol
4 Return to Operating Room for debridement manipulation other surgical interventions
5 Surgical Site Infection SSI
6 Confirmed Periprosthetic Joint Infection PJI
7 Stiffness requiring Manipulation Under Anesthesia MUA
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