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Aquacel Hypersensitivity Dressing in TJAs

Primary Purpose

Contact Allergic Dermatitis, Adverse Skin Reaction

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Aquacel dressing
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Contact Allergic Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients older than 18 years that underwent primary total hip arthroplasty (THA) Patients older than 18 years that underwent primary total or unicompartmental knee arthroplasty (TKA/UKA) Exclusion Criteria: Revision surgery Prior history of allergic contact dermatitis Prior history of non-TJA or UKA surgery with AQUACEL Ag dressing post-op Occupational exposure to surgical dressings Documented history of silver allergy

Sites / Locations

  • Rush University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Arthroplasty-naïve Aquacel group

Prior Aquacel group

Arm Description

All subject's receive the same dressing, this group is comprised of patients consented to the study and will receive the Aquacel dressing but have not had previous joint replacement surgery. Therefore, we consider them the arthroplasty-naïve Aquacel group.

All subject's receive the Aquacel dressing, this group is comprised of patients who have undergone previous joint replacement surgery (hip or knee) and have had a Aquacel dressing. This also includes patients who have had prior exposure to glue/mesh dressing either as a patient or healthcare worker.

Outcomes

Primary Outcome Measures

Rate of contact allergic dermatitis or adverse skin reaction at 1 week post surgery
Using a classification of skin reactions from mild, moderate to severe
Rate of contact allergic dermatitis or adverse skin reaction at 2-3 weeks post surgery
Using a classification of skin reactions from mild, moderate to severe

Secondary Outcome Measures

Wound complications (if applicable)
If patients present with wound complications, require possible work up for infection, require antibiotics outside of normal protocol due to concerns of infection, return to the operating room, confirmed periprosthetic joint infection or stiffness that requires a manipulation under anesthesia
Wound complications (if applicable)
If patients present with wound complications, require possible work up for infection, require antibiotics outside of normal protocol due to concerns of infection, return to the operating room, confirmed periprosthetic joint infection or stiffness that requires a manipulation under anesthesia

Full Information

First Posted
August 21, 2023
Last Updated
August 21, 2023
Sponsor
Rush University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT06011629
Brief Title
Aquacel Hypersensitivity Dressing in TJAs
Official Title
Prospective Evaluation of Type IV Hypersensitivity Reactions After Aquacel Dressing Application in Partial and Total Joint Arthroplasty Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 18, 2023 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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. Relevant variables that will be collected include: Inclusion Criteria: Patients older than 18 years that underwent primary total hip arthroplasty (THA) Patients older than 18 years that underwent primary total or unicompartmental knee arthroplasty (TKA/UKA) Exclusion Criteria: Revision surgery Prior history of allergic contact dermatitis Prior history of non-TJA or UKA surgery with AQUACEL Ag dressing post-op Occupational exposure to surgical dressings Documented history of silver allergy 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 1:1 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). Demographic/Patient Specific Data Collected: Age, Sex, Body Mass Index (BMI), Allergy History, Past Surgical History, Prior exposure to surgical dressing (Either occupational (i.e. healthcare worker) or as a patient), Number of prior arthroplasty surgeries with AQUACEL Ag dressing (i.e. 0, 1, 2, 3), Past adverse reaction to AQUACEL Ag dressing, Any Adverse Skin Reactions with any past adhesive exposure Operative details: Surgical date, Operation/Laterality (THA/TKA/UKA, Left/Right), Length of incision, Patient reported skin check at 1 week (via picture from patient if wound issue/skin 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 Wound complications Any workup for PJI (Serologic labs (ESR/CRP), 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contact Allergic Dermatitis, Adverse Skin Reaction

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arthroplasty-naïve Aquacel group
Arm Type
Other
Arm Description
All subject's receive the same dressing, this group is comprised of patients consented to the study and will receive the Aquacel dressing but have not had previous joint replacement surgery. Therefore, we consider them the arthroplasty-naïve Aquacel group.
Arm Title
Prior Aquacel group
Arm Type
Other
Arm Description
All subject's receive the Aquacel dressing, this group is comprised of patients who have undergone previous joint replacement surgery (hip or knee) and have had a Aquacel dressing. This also includes patients who have had prior exposure to glue/mesh dressing either as a patient or healthcare worker.
Intervention Type
Device
Intervention Name(s)
Aquacel dressing
Intervention Description
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. Arthroplasty-naïve patients will be compared to prior total joint arthroplasty patients who received a Aquacel dressing postoperatively.
Primary Outcome Measure Information:
Title
Rate of contact allergic dermatitis or adverse skin reaction at 1 week post surgery
Description
Using a classification of skin reactions from mild, moderate to severe
Time Frame
7 days post surgery
Title
Rate of contact allergic dermatitis or adverse skin reaction at 2-3 weeks post surgery
Description
Using a classification of skin reactions from mild, moderate to severe
Time Frame
2-3 weeks following surgery
Secondary Outcome Measure Information:
Title
Wound complications (if applicable)
Description
If patients present with wound complications, require possible work up for infection, require antibiotics outside of normal protocol due to concerns of infection, return to the operating room, confirmed periprosthetic joint infection or stiffness that requires a manipulation under anesthesia
Time Frame
1 week post surgery
Title
Wound complications (if applicable)
Description
If patients present with wound complications, require possible work up for infection, require antibiotics outside of normal protocol due to concerns of infection, return to the operating room, confirmed periprosthetic joint infection or stiffness that requires a manipulation under anesthesia
Time Frame
2-3 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients older than 18 years that underwent primary total hip arthroplasty (THA) Patients older than 18 years that underwent primary total or unicompartmental knee arthroplasty (TKA/UKA) Exclusion Criteria: Revision surgery Prior history of allergic contact dermatitis Prior history of non-TJA or UKA surgery with AQUACEL Ag dressing post-op Occupational exposure to surgical dressings Documented history of silver allergy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne DeBenedetti, MSc
Phone
3124322468
Email
anne.debenedetti@rushortho.com
First Name & Middle Initial & Last Name or Official Title & Degree
Conor Jones, MD
Phone
3124322468
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne DeBenedetti, MSc
Phone
312-432-2468
First Name & Middle Initial & Last Name & Degree
Conor Jones, MD
Phone
3124322468
First Name & Middle Initial & Last Name & Degree
Vasili Karas, MD
First Name & Middle Initial & Last Name & Degree
Craig Della Valle, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Once complete, we will share the summary of the data along with study protocol and SAP
IPD Sharing Time Frame
Once the study is fully enrolled

Learn more about this trial

Aquacel Hypersensitivity Dressing in TJAs

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