Aquacel Dressing for Allergic Skin Reactions

Overseen By Conor Jones, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Rush University Medical Center

Disqualifiers: Revision surgery, Contact dermatitis, Silver allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special type of bandage called Aquacel, which contains silver, to determine if it causes allergic skin reactions in individuals who have undergone hip or knee replacement surgery. The researchers aim to compare individuals who have never had joint replacement surgery before with those who have and have previously used this bandage. They seek participants who have recently had their first hip or knee replacement surgery and do not have a history of skin allergies to these types of dressings. As a Phase 4 trial, this research helps to understand how the already FDA-approved and effective bandage benefits more patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What is the safety track record for the Aquacel dressing?

Research has shown that Aquacel dressings can sometimes cause skin reactions. Some individuals have reported redness and rashes after using these dressings. In a few instances, the skin where the dressing was applied turned a deep red. These reactions can include redness and blistering after the dressing is removed.

Another study found that certain ingredients in dressings, such as hydrocolloids (a type of gel used for wound care), might cause allergies. People with sensitive skin might experience irritation when using these products.

Overall, while many people use Aquacel without problems, some do experience skin reactions. It's important to consider this if there is a history of skin allergies. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Aquacel is unique because it offers a different approach to managing allergic skin reactions compared to standard dressings like cotton gauze or non-woven fabric. This dressing uses Hydrofiber technology, which absorbs wound exudate and transforms into a gel, maintaining a moist environment that promotes healing while reducing the risk of infection. Researchers are excited about Aquacel because it may provide a more comfortable and effective option for patients, particularly those who have had joint replacement surgeries or exposure to other dressings. Unlike traditional dressings, Aquacel could potentially speed up healing and offer better protection against allergens, making it a promising alternative.

What evidence suggests that Aquacel dressing is effective for allergic skin reactions?

Research has shown that Aquacel dressings can improve skin conditions. One study found that 76.2% of patients experienced improvement in their skin ulcers, with ulcers reducing in size by 54.5%. However, some individuals developed skin allergies after using Aquacel, necessitating a switch to a different dressing. This trial will evaluate Aquacel dressings in two groups: the arthroplasty-naïve Aquacel group and the prior Aquacel group. Aquacel effectively keeps wounds moist, aiding in healing, but some individuals might experience allergic reactions. Overall, while Aquacel can be effective, its success may depend on skin sensitivity. ^{1 3 6 7 8}

Who Is on the Research Team?

Vasili Karas, MD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have had a first-time hip or knee replacement surgery. It's not for people with past allergic skin reactions, those exposed to surgical dressings at work, anyone with silver allergies, or patients having revision surgeries.

Exclusion Criteria

You have had allergic skin reactions in the past.

You work with surgical dressings as part of your job.

I am scheduled for or have had a revision surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Application of AQUACEL Ag dressing post-surgery and monitoring for allergic contact dermatitis

3 weeks

1 visit (in-person) at 1 week, 1 visit (in-person) at 2-3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of wound complications and adverse skin reactions

4 weeks

1 visit (in-person) at 4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Aquacel

Trial Overview The study is looking at the rate of skin allergies after using Aquacel Ag dressing in new hip and knee joint replacement patients compared to those who've had replacements before and used the same dressing.

How Is the Trial Designed?

Group I: Prior Aquacel group Experimental Treatment 1 Intervention

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.

Group II: Arthroplasty-naïve Aquacel group Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Published Research Related to This Trial

AQUACEL™ Ag+ dressing demonstrated an acceptable safety profile in treating chronic venous leg ulcers, with only one patient discontinuing due to a non-treatment-related adverse event during the 8-week study involving 42 patients.

After 8 weeks of treatment, 76.2% of patients showed improvement in their ulcers, with a significant average reduction in ulcer size of 54.5%, indicating its efficacy in managing wounds potentially affected by biofilm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and performance evaluation of a next-generation antimicrobial dressing in patients with chronic venous leg ulcers. Harding, KG., Szczepkowski, M., Mikosiński, J., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5558629/

AQUACEL® Ag Surgical Dressing Reduces ... Five patients had skin allergies after application of AQUACEL Ag Surgical dressing and were switched to standard dressing. Three patients in the control ...

2. withpower.com withpower.com/trial/phase-4-dermatitis-atopic-7-2023-ea9cf

Aquacel Dressing for Allergic Skin Reactions After 8 weeks of treatment, 76.2% of patients showed improvement in their ulcers, with a significant average reduction in ulcer size of 54.5%, indicating its ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06011629/aquacel-hypersensitivity-dressing-in-tjas

Aquacel Hypersensitivity Dressing in TJAs Primary Outcome Measure: The primary outcome is the rate of contact allergic dermatitis or adverse skin reaction at 1 week post op and 1st ...

4. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6908631&pc=FRO

MAUDE Adverse Event Report:; AQUACEL SURGICAL ... Based on review of the photographs provided, the patient appeared to have a clear deep red reaction to the entire skin surface that encountered the hydrocolloid ...

5. trial.medpath.com trial.medpath.com/clinical-trial/b509b72fbb49ed0c/nct06011629-prospective-evaluation-hypersensitivity-reactions-aquacel-dressing-joint-arthroplasty

Aquacel Hypersensitivity Dressing in TJAs | MedPath 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) ...

6. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6877601&pc=FRO

MAUDE Adverse Event Report:; AQUACEL AG SURGICAL The end user began developing areas of red rash solid in color on her trunk, arms, legs and back (24 hours) after the dressing was removed and went to urgent ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11896758/

Allergic Contact Dermatitis Induced by Modern Wound ... The study found that hydrocolloids and hydrogels are more likely to cause allergies due to substances like, colophony and propyleneglycol respectively.

8. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5377865&pc=FRO

MAUDE Adverse Event Report: CONVATEC, INC. AQUACEL ... Upon removal, the patient's skin showed signs of an "allergic reaction/contact dermatitis" with redness and blistering under the adhesive portion of the ...