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

NCT07391748 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-02-10

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-30
Primary Completion
2026-04-30
Completion
2026-09-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07391748 on ClinicalTrials.gov