An ostomy baseplate with a skin-protection technology reduces peristomal skin complications: a randomized controlled trial (the ATTRACT study)
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View abstract on PubMed
Summary
This summary is machine-generated.A new ostomy baseplate with skin-protection technology significantly reduced peristomal skin complications (PSCs) and improved quality of life for stoma patients. This innovative product was preferred by participants, offering a potential solution for leakage-induced PSCs.
Area Of Science
- Medical Devices
- Wound Care
- Stoma Therapy
Background
- Peristomal skin complications (PSCs) are common issues for individuals with stomas, negatively impacting their quality of life and increasing healthcare costs.
- Effective strategies are needed to prevent or reduce PSCs, highlighting the demand for innovative ostomy care products.
Purpose Of The Study
- To evaluate the performance of a novel ostomy baseplate featuring skin-protection technology.
- To assess the efficacy of the investigational product in managing PSCs and improving health-related quality of life (HRQoL) in stoma patients with liquid effluent.
Main Methods
- A randomized, controlled, open-labelled, cross-over trial involving 79 adult participants across five countries.
- Participants used both the investigational ostomy baseplate and a comparator product (SenSura® Mio).
- Peristomal skin condition was assessed using the Ostomy Skin Tool 2.0, and HRQoL was measured via the Dermatology Life Quality Index (DLQI).
Main Results
- The investigational ostomy baseplate demonstrated a significant reduction in PSCs (P = 0.015) compared to the comparator.
- A significant improvement in HRQoL was observed with the investigational product (P = 0.035).
- A significantly higher proportion of participants preferred the investigational product over the comparator (P = 0.017).
Conclusions
- The ostomy baseplate with skin-protection technology effectively reduces PSCs and enhances HRQoL in individuals with stomas and liquid faecal effluent.
- The investigational product was preferred by participants, suggesting it as a promising new solution for managing leakage-induced PSCs in clinical practice.
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