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

400 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Aquacel for allergic skin reactions?

Aquacel, particularly in its silver-impregnated form (Aquacel Ag), has been shown to be effective in managing partial-thickness burns by promoting healing and reducing pain during dressing changes. While this is not directly related to allergic skin reactions, the ability of Aquacel to create a healing environment and reduce discomfort may suggest potential benefits for other skin conditions. ^{1 2 3 4 5}

Is Aquacel dressing safe for use in humans?

Aquacel dressings, including those with added silver (Aquacel Ag), have been shown to be safe in various studies involving patients with venous leg ulcers and burns. Adverse events were rare, and the dressings were generally well-tolerated, with benefits such as reduced pain and fewer dressing changes. ^{2 3 6 7 8}

How does Aquacel Dressing differ from other treatments for allergic skin reactions?

Aquacel Dressing is unique because it is a silver-impregnated hydrofiber that releases silver for up to two weeks, which helps reduce the frequency of dressing changes and provides a moist environment that promotes healing. This is different from other treatments that may require more frequent changes and do not offer the same sustained release of silver, which can help prevent infection and reduce pain during dressing changes. ^{2 3 4 7 8}

Research Team

Vasili Karas, MD

Principal Investigator

Rush University Medical Center

Eligibility Criteria

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.

Inclusion Criteria

I am over 18 and have had a total hip replacement.

I am over 18 and had a knee replacement surgery.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

A real-life clinical evaluation of a next-generation antimicrobial dressing on acute and chronic wounds. [2014]

2. Germany pubmed.ncbi.nlm.nih.gov

Silver containing hydrofiber dressing promotes wound healing in paediatric patients with partial thickness burns. [2018]

3. Italy pubmed.ncbi.nlm.nih.gov

Aquacel ag® in paediatric burns - a prospective audit. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Evaluation of Aquacel Ag for Autogenous Skin Donor Sites. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of two absorbent silver dressings in a porcine partial-thickness excisional wound model. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Safety and performance evaluation of a next-generation antimicrobial dressing in patients with chronic venous leg ulcers. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Aquacel Ag in the management of partial-thickness burns: results of a clinical trial. [2016]

8. England pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Study of Silver-Based Burns Dressing in a Pediatric Emergency Department. [2018]