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Silicone Barrier Spray Versus Zinc Oxide Ointment for Incontinence-Associated Dermatitis

2026年6月9日 更新者:Taoyuan Armed Forces General Hospital

Effectiveness of Structured Skin Care Using Silicone Barrier Spray Compared With Zinc Oxide Ointment for Incontinence-Associated Dermatitis in Long-Term Care Residents: A Randomized Controlled Trial

Incontinence-associated dermatitis (IAD) is a common skin condition among long-term care residents and is caused by prolonged exposure to urine or feces. IAD can lead to skin irritation, discomfort, impaired skin integrity, and an increased risk of secondary complications. Structured skin care, including cleansing and barrier protection, is recommended for the prevention and management of IAD.

This randomized controlled trial evaluated the effectiveness of a silicone barrier spray compared with zinc oxide ointment as part of a structured skin care program for residents with mild IAD in a long-term care facility. Participants were randomly assigned to receive either silicone barrier spray or zinc oxide ointment following routine skin cleansing. Clinical severity of IAD and skin barrier function were assessed at baseline, Day 7, and Day 14 using standardized clinical and biophysical measurements, including IAD severity score, skin hydration, transepidermal water loss, skin pH, and skin temperature. The study aimed to determine whether silicone barrier spray provides comparable or improved outcomes compared with conventional zinc oxide ointment in the management of mild IAD.

調査の概要

詳細な説明

Incontinence-associated dermatitis (IAD) is a common form of moisture-associated skin damage resulting from prolonged exposure of the skin to urine and/or feces. The condition is particularly prevalent among residents of long-term care facilities because of advanced age, reduced mobility, cognitive impairment, chronic illness, and urinary or fecal incontinence. IAD is associated with erythema, discomfort, pain, impaired skin barrier function, and an increased risk of secondary complications, including pressure injuries and skin infections.

Maintenance of skin barrier integrity is a fundamental component of IAD prevention and treatment. Current international guidelines recommend structured skin care programs consisting of routine cleansing, moisturization, and barrier protection. Zinc oxide-based ointments are among the most commonly used barrier products because they provide effective protection against moisture and irritants. However, zinc oxide formulations may be difficult to apply and remove, can leave residue on the skin, and may increase friction during repeated cleansing procedures.

Silicone-based barrier films represent an alternative approach to skin protection. These products form a transparent, breathable, water-resistant layer on the skin surface and may reduce friction while preserving epidermal barrier function. Sprayable silicone barrier formulations may provide additional practical advantages, including rapid application, uniform coverage, reduced physical contact with damaged skin, and improved ease of use for caregivers. Such characteristics may be particularly valuable in long-term care settings where frequent skin care interventions are required.

Despite increasing clinical use of silicone-based barrier products, direct randomized comparisons between sprayable silicone barrier films and traditional zinc oxide ointments remain limited. Furthermore, objective evaluations of skin barrier recovery using biophysical measurements have not been extensively investigated in long-term care populations with IAD.

The purpose of this study was to compare the effectiveness of a silicone barrier spray and zinc oxide ointment when incorporated into a structured skin care program for long-term care residents with mild incontinence-associated dermatitis. In addition to evaluating clinical improvement, the study investigated changes in skin barrier function using objective biophysical assessments. The findings of this study are intended to provide evidence to support clinical decision-making regarding barrier protection strategies and to improve skin care practices for vulnerable older adults residing in long-term care facilities.

研究の種類

介入

入学 (実際)

40

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Taoyuan City
      • Longtan、Taoyuan City、台湾、325
        • Taoyuan Armed Forces General Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 子
  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

Inclusion Criteria:

  • Resident of a long-term care facility.
  • Diagnosis of mild incontinence-associated dermatitis (IAD), classified as GLOBIAD Category 1.
  • Ability to provide informed consent personally or through a legally authorized representative.
  • Willingness to participate in the study and comply with study procedures.

Exclusion Criteria:

  • Incontinence-associated dermatitis (IAD) classified as GLOBIAD Category 2.
  • Presence of skin erosion, skin loss, open wounds, or active skin infection in the assessment area.
  • Known allergy or hypersensitivity to silicone-based barrier products or zinc oxide preparations.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:独身

武器と介入

参加者グループ / アーム
介入・治療
実験的:Silicone Barrier Spray
Participants received a silicone-based barrier spray after structured skin cleansing and moisturizing care throughout the 14-day study period.
A silicone-based skin barrier spray (Brava® Skin Barrier Spray, Coloplast A/S, Denmark) was applied to the perineal skin after each cleansing episode as part of a structured skin care regimen. The spray forms a transparent, breathable, water-resistant protective film designed to reduce moisture-related skin damage and friction while maintaining skin barrier integrity. Participants received the intervention throughout the 14-day study period following routine cleansing and moisturizing care.
アクティブコンパレータ:Zinc Oxide Ointment
Participants received zinc oxide ointment after structured skin cleansing and moisturizing care throughout the 14-day study period.
A traditional zinc oxide-based barrier ointment applied to the perineal skin after routine cleansing and moisturizing care. The ointment forms a protective barrier that helps reduce skin exposure to moisture, irritants, and friction associated with urinary and fecal incontinence. The intervention was administered as part of a structured skin care protocol throughout the 14-day study period.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Change in Incontinence-Associated Dermatitis Severity Score
時間枠:Baseline (Day 1), Day 7, and Day 14
Clinical severity of incontinence-associated dermatitis assessed using the modified Ghent Global Incontinence-Associated Dermatitis Monitoring Tool (GLOBIAD-M). Scores ranged from 0 (normal skin) to 2 (more severe dermatitis), with lower scores indicating improvement in skin condition.
Baseline (Day 1), Day 7, and Day 14

二次結果の測定

結果測定
メジャーの説明
時間枠
Skin Hydration
時間枠:Baseline (Day 1), Day 7, and Day 14
Skin hydration measured using stratum corneum capacitance at affected skin sites.
Baseline (Day 1), Day 7, and Day 14
Transepidermal Water Loss (TEWL)
時間枠:Baseline (Day 1), Day 7, and Day 14
Skin barrier function assessed by measuring transepidermal water loss (g/m²/h) using a closed-chamber evaporimeter.
Baseline (Day 1), Day 7, and Day 14
Skin pH
時間枠:Baseline (Day 1), Day 7, and Day 14
Skin surface pH measured at affected skin sites using a flat-surface electrode device.
Baseline (Day 1), Day 7, and Day 14
Skin Temperature
時間枠:Baseline (Day 1), Day 7, and Day 14
Skin temperature measured at affected skin sites using a skin assessment device.
Baseline (Day 1), Day 7, and Day 14

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Po Jen Hsiao, MD, PhD、Taoyuan Armed Forces General Hospital
  • スタディチェア:Hsieh Chih Tsai, PhD、National Taiwan University of Science and Technology
  • スタディディレクター:Po Chung Chen, MD, MS、Taoyuan Armed Forces General Hospital

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2023年1月1日

一次修了 (実際)

2023年11月30日

研究の完了 (実際)

2023年11月30日

試験登録日

最初に提出

2026年6月4日

QC基準を満たした最初の提出物

2026年6月4日

最初の投稿 (実際)

2026年6月10日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月11日

QC基準を満たした最後の更新が送信されました

2026年6月9日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • TYAFGH-D-112032

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

Individual participant data will not be made publicly available because the informed consent and ethics approval did not include provisions for public data sharing. Data contain potentially identifiable information from residents of a long-term care facility, and sharing is restricted to protect participant privacy and confidentiality.

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