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

NCT07391748 | Not Yet Recruiting Early Phase 1 DMC

• 1 other identifier: 20250929
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Pressure ulcers; biofilms; primary prevention; antimicrobial agents

Outcome Measures

Primary Outcomes (1)

• Change from baseline in RESVECH 2.0 score at four weeks in patients with category II and III pressure ulcers treated with polyhexanide-biguanide gel alone or combined with alginate dressing with or without silver, compared with standard care.

  From enrollment to the end of treatment at 4 weeks

Study Arms (2)

Gel polihexanida- biguanida Factor

ACTIVE COMPARATOR

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

Hydrofiber of hydrocolloid with silver (Ag)

ACTIVE COMPARATOR

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

Interventions

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 COMBINATION_PRODUCT

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.

Gel polihexanida- biguanida Factor; Hydrofiber of hydrocolloid with silver (Ag)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Bedridden patients, patients with bed-to-chair mobility, or those in a wheelchair.
• Presenting one or more category II-III pressure ulcers.
• Aged over 65 years.
• Patients with laboratory results within normal metabolic values (HbA1c \< 7%).
• Patients who, in item 6 "infection/suspected biofilm" of the RESVECH 2.0 index, do not have tissue compatible with biofilm, hypergranulation, or purulent exudate, and never score more than 4 in the other items.
• During follow-up, cases that develop signs and symptoms of local infection according to TILI and/or the RESVECH 2.0 index will be considered therapeutic failures, allowing for clinical rescue, but the patient will remain in the intention-to-treat (ITT) analysis.

You may not qualify if:

• Patients who, despite the above, present a deteriorated health status that could influence the outcome, such as terminally ill patients, oncology patients, or those with inflammatory diseases.
• Patients in a state of malnutrition according to the Mini Nutritional Assessment (MNA®) scale who are not receiving nutritional supplements, and/or at risk of malnutrition with nutritional deficits.
• Patients with pressure ulcers in the perineal area and urinary incontinence (except those with a urinary catheter) and/or fecal incontinence.

Sponsors & Collaborators

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

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Biguanides; Single Person; Alginates; Silver

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors; Polysaccharides; Carbohydrates; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Alma Balaguer Menchero

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: February 6, 2026
• Study Start: January 30, 2026
• Primary Completion: April 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02