NCT07391748

Efficacy of a Polyhexanide Biguanide-Based Gel in the Prevention of Biofilm Formation in Pressure Ulcers

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

INTRODUCTION: Pressure ulcers (PU) are one of the main challenges for nursing in our country. Wound bed preparation and the TIME algorithm provide essential tools for adequately treating these lesions. However, these wounds tend to become chronic due to the bacterial load in their bed. It is now known that bacteria can form complex and diverse structures, named as biofilm, which are difficult to diagnose and much more resistant to antimicrobial action. Controlling these biofilms is crucial to create the optimal conditions for wound healing. Currently, it is believed that biofilms are present in 60-100% of chronic wounds. Therefore, more studies are needed to evaluate the efficacy of different antimicrobial agents on these structures. OBJECTIVE: To determine the efficacy of a gel containing polyhexanide and biguanide, alone or in combination with alginate with or without silver, in preventing biofilm in PU, in terms of healing at 4 weeks. METHODOLOGY: Multicenter clinical trial with a 2x2 factorial design, conducted with patients from Alcoy with category II and III PUs that meet the inclusion and exclusion criteria. A sample of 140 participants is estimated, distributed into four groups of 35 patients. The interventions that will be carried out will be: application of Prontosan gel® and Aquacel Ag+®; Aquacel Ag+®; control group; Prontosan gel®. Data on wound evolution will be collected using RESVECH 2.0. Descriptive statistical analysis and hypothesis testing will be performed.

Conditions

• Pressure Ulcers
• Pressure Ulcers Stage III
• Pressure Ulcer Prevention
• Pressure Ulcer ( Stage 2-3)
• Biofilm Formation
• Biofilm
• Biofilm Removal

Interventions

Type	Name	Description
COMBINATION_PRODUCT	To determine the efficacy of a gel containing polyhexanide and biguanide, alone or in combination with alginate with or without silver, in preventing biofilm in PU, in terms of healing at 4 weeks	The intervention consists of the topical application of a gel containing polyhexanide and biguanide (Prontosan®), either alone or in combination with a silver-containing alginate dressing (Aquacel Ag+®), specifically for category II and III pressure ulcers. Its efficacy in preventing bacterial biofilm formation in the wound bed and its impact on healing over a four-week period are being evaluated, following the TIME algorithm for wound bed preparation. The study employs a 2×2 factorial design, with four treatment groups (gel alone, silver dressing alone, combination of both, and control), and uses standardised assessment tool RESVECH 2.0 to monitor wound progression.

Timeline

• Start date: 2026-01-30
• Primary completion: 2026-04-30
• Completion: 2026-09-30
• First posted: 2026-02-06
• Last updated: 2026-02-10