Clinical Relevance of the Antimicrobial Resistance Testing in the Treatment of Chronic Wounds With Antiseptics

NCT ID: NCT04172363

Last Updated: 2022-10-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-22
• Study Completion Date: 2021-05-22

Brief Summary

The study objective is to improve the current and local standard antiseptic treatment by adjusting the antiseptic agent to the antimicrobial resistance testing result, accordingly. Currently, resistance testing will only be performed for the treatment with antibiotics.

Detailed Description

Complications like bacterial wound colonization and infections in wound treatment are still a serious problem. Several therapy approaches are available to treat these complications, e.g. surgical wound debridement, antimicrobial therapy that can be divided into a local and a systemic antisepsis.

The local antisepsis (the local utilization of antiseptics directly to the wound) is in many ways advantageous to the systemic antisepsis (orally or intravenously administered antibiotics): e. g. the direct contact of the antiseptic to the bacteria at the site of infection whereas antibiotics may not sufficiently reach the wound due to limited blood perfusion of wounds; growing utilization of systemic antisepsis also leads to an increasing number of resistant bacteria worldwide. To the concerns of many specialists, the first pan-resistant bacterial strain which is resistant to all available antibiotics including colistin was recently published.

In future, the role of local antisepsis therefore becomes more important in the antimicrobial treatment. Luckily, resistances of local antiseptics occur slowly due to the chemical and structural characteristics of antiseptics but even resistances of bacteria to antiseptics were reported. Unlike the antimicrobial resistance testing for antibiotics that is done in the clinical routine, such testing is not a standard procedure for antiseptics for no obvious reason. The utilization of antiseptics is determined by the availability of products provided within the institution and preferences of the clinician. Thus, it is unknown whether the chosen antiseptic has any bactericidal effect on the confirmed bacteria.

University Hospital RWTH Aachen Wound Care only uses polyhexanide and octenisept. Iodine-containing preparations are explicitly not desired.Improvement (bacteria reduction, acceleration of wound healing) of the local antiseptic therapy by adapting the antiseptic to the results of antimicrobial resistance testing. Antimicrobial resistance testing has so far only been used to adapt systemic antibiotic therapy.

Conditions

Decubiti; Chronic Wounds; Acute Wounds

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Care

Octenisept will be used as standard care antiseptic for dressing change

Group Type: NO_INTERVENTION

No interventions assigned to this group

Resistance testing

Patients will be first tested on resistance to Octenisept and Serasept and will receive the appropriate antiseptic after reviewing the results

Group Type: EXPERIMENTAL

Octenisept and Serasept

Intervention Type: DRUG

Swab probes of wounds will be taken upon study inclusion and analysed for resistance on Octenisept and Serasept. If the patient indicates resistance on one of the antiseptics, he/she will receive the other antiseptic for wound dressings

Interventions

Octenisept and Serasept

Swab probes of wounds will be taken upon study inclusion and analysed for resistance on Octenisept and Serasept. If the patient indicates resistance on one of the antiseptics, he/she will receive the other antiseptic for wound dressings

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years

2. Decubitus OR secondary healing acute and chronic wounds

3. Positively tested wound swab for bacteria (incl. multi-resistant bacteria)

4. Patient is capable of understanding the nature, significance and consequence of the clinical trial

5. Given written consent

6. Women of child bearing potential (WOCBP) who apply appropriate methods of contraception throughout the duration of the study

Exclusion Criteria

1. Occlusive dressing (e.g. VAC) or Negative Pressure Wound Therapy (NPWT)

2. Pregnant or lactating women

3. Known allergies against investigational products

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RWTH Aachen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian Stoppe, Prof.

Role: PRINCIPAL_INVESTIGATOR

Aachen University Hospital

Locations

University Hospital RWTH Aachen

Aachen, North Rhine-Westphalia, Germany

Countries

Germany

Other Identifiers

17-169

Identifier Type: -

Identifier Source: org_study_id