Skin Protectant Textile for Moisture-Associated Skin Damage

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medline Industries

Must not be taking: Antibiotics, Antifungals, Ointments, others

Disqualifiers: Allergy to SPT, others

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

Compensation: Varies

Number of Visits: 4

Duration: 5 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of the DriGo skin protectant textile in healing and managing issues like redness, skin peeling, and irritation in skin folds. Participants will apply this fabric to affected areas, and both doctors and participants will provide feedback on changes over several days. Individuals with ongoing skin issues such as pain, itching, or moisture in their skin folds, who can participate for six days, might be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance skin care solutions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if your skin conditions are being treated with certain topical treatments like antibiotics or antifungals.

What prior data suggests that the DriGo skin protectant textile is safe for managing skin fold conditions?

Research has shown that the DriGo Skin Protectant Textile (SPT) is generally safe for use. This material pulls moisture away from the skin, keeping it dry. By doing so, it helps prevent bacterial growth and reduces odor, which benefits individuals with skin fold conditions. The textile's antibacterial properties protect the skin, though information on side effects remains limited. Studies with similar materials indicate that reactions are rare and usually mild, such as slight skin irritation. As this study is in the early stages, detailed safety information is not yet available. However, its design for skin protection suggests it is well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The DriGo Skin Protectant Textile is unique because it offers a physical barrier to protect against moisture-associated skin damage, which is different from the creams and ointments typically used for this condition. Unlike these traditional treatments, which often involve the application of topical agents to manage moisture and irritation, DriGo is a textile that can be applied directly to the skin folds, providing continuous protection throughout the day. Researchers are excited about this approach because it could lead to more consistent and long-lasting protection while reducing the need for frequent reapplication of creams or ointments.

What evidence suggests that the DriGo skin protectant textile is effective for skin fold conditions?

Research has shown that the DriGo Skin Protectant Textile (SPT) helps with skin fold issues by keeping the skin dry and comfortable. Lab tests revealed the fabric's antibacterial qualities, which can reduce odors and irritation. It also controls moisture, often a cause of skin problems like redness and soreness. Early results suggest that this fabric may ease symptoms such as pain, itching, and burning in affected areas. Its ability to keep the skin dry and act as a protective layer makes it a promising choice for those with skin fold conditions. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with skin fold conditions like redness, moisture damage, and lesions. They must be able to have their condition assessed for up to six days. People with allergies to the SPT's ingredients or those using certain topical treatments can't participate.

Inclusion Criteria

You have skin conditions such as redness, moisture, odor, or discomfort in certain areas.

People whose skin can be checked for up to six days as part of their treatment plan.

Exclusion Criteria

You are allergic to the materials used in the skin prick test or the tape used to secure it.

You are using topical treatments like antibiotics, antifungals, or ointments in the area being studied.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive the DriGo skin protectant textile (SPT) applied to their skin fold conditions. Assessments are conducted on Day 0, and on Days 1, 3, and 5.

5 days

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DriGo Skin Protectant Textile

Trial Overview The study tests DriGo Skin Protectant Textile on managing symptoms associated with skin folds such as erythema, lesions, and discomfort. Healthcare providers apply it and monitor changes over five days through photographs and patient feedback.

How Is the Trial Designed?

Group I: DriGo SPT Experimental Treatment 1 Intervention

All participants will have the DriGo skin protectant textile applied to their skin fold condition.

Who Is Running the Clinical Trial?

Medline Industries

Lead Sponsor

Trials

46

Recruited

23,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05742347

NCT05742347 | Skin Protectant Textile Efficacy Study for ... This study will evaluate the efficacy of the DriGo skin protectant textile (SPT) to manage erythema, maceration, denudation, satellite lesions, pain, ...

2. medline.com medline.com/media/assets/pdf/OTH_DriGo%20HP_White%20Paper.pdf

DriGo-HP™: Laboratory Testing for Antibacterial Properties Medline DriGo-HP is a soft, thin, smooth polyester fabric that helps with management of moisture, and provides comfort and odor control. DriGo-HP manages ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05742347?term=AREA%5BInterventionSearch%5D(Protective%20Agents)%20AND%20SEARCH%5BLocation%5D(AREA%5BLocationCountry%5DUnited%20States)&rank=2

Skin Protectant Textile Efficacy Study for Managing ... There are three types of violations: Failure to submit required clinical trial information; Submission of false or misleading clinical trial information ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5657465/

Management of Moisture-Associated Skin Damage The authors propose key interventions to protect and prevent MASD including the use of barrier ointments, liquid polymers, and cyanoacrylates.

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06178289/effectiveness-of-3m-cavilon-advanced-skin-protectant-in-the-treatment-of-moisture-associated-skin-damage-in-hospitals

Effectiveness of 3M Cavilon Advanced Skin Protectant in ... Objectives: The aim of this study is to evaluate the effectiveness of 3M™ Cavilon™ Advanced Skin Protectant in the treatment of ...

6. withpower.com withpower.com/trial/phase-erythema-6-2022-8659b

Skin Protectant Textile for Moisture-Associated Skin Damage Trial Overview The study tests DriGo Skin Protectant Textile on managing symptoms associated with skin folds such as erythema, lesions, and discomfort.

7. clwk.ca clwk.ca/get-resource/drigo-hp/

DriGo-HP Preventing bacterial growth also limits odour. • Designed to wick moisture away from the skin fold, into the fabric and towards the end of the fabric that ...

8. medline.com medline.com/skin-health/remedy-drigo/

Remedy ® DriGo-HP™ Antibacterial Wicking Sheets This ultra soft, long-lasting antibacterial wicking sheet makes it easier to protect at-risk skin and keep patients safe.