Clinical trial NCT04172363: Clinical Relevance of the Antimicrobial Resistance Testing in the Treatment of Chronic Wounds With Antiseptics
Official title: Clinical Relevance of the Antimicrobial Resistance Testing in the Treatment of Chronic Wounds With Antiseptics
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Decubiti
Chronic Wounds
Acute Wounds
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is monocentric, prospective, controlled, open, randomized, 2-armed interventional pilot trial.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in bacteria rate
timeFrame: up to 12 months
Secondary outcomes:
measure: Incidence of wound related adverse events
timeFrame: up to 12 months
measure: Change in Pressure Ulcers: Scale for Healing (PUSH) score
timeFrame: up to 12 months
measure: Change in Bates-Jensen Score
timeFrame: up to 12 months
measure: Laboratory Parameters - Change in C-reactive protein (CRP)
timeFrame: up to 12 months
measure: Laboratory Parameters - Change in Leukocytes
timeFrame: up to 12 months
measure: Laboratory Parameters - Change in hemoglobin
timeFrame: up to 12 months
measure: Laboratory Parameters - Change in hematokrit
timeFrame: up to 12 months
measure: Laboratory Parameters - Change in creatinine
timeFrame: up to 12 months
measure: Laboratory Parameters - Change in glomerular filtration rate (GFR)
timeFrame: up to 12 months
measure: Laboratory Parameters - Change in Uric acid
timeFrame: up to 12 months
measure: Laboratory Parameters - Change in glutamic-pyruvic transaminase (GPT)
timeFrame: up to 12 months
measure: Laboratory Parameters - Change in Glutamat-Oxalacetat- Transaminase (GOT)
timeFrame: up to 12 months
measure: Laboratory Parameters - Change in Glucose
timeFrame: up to 12 months
measure: Hospital length of stay
timeFrame: up to 12 months
measure: Rate of antibiotics used
timeFrame: up to 12 months
measure: Length of bed confinement
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital RWTH Aachen
state: NRW
Study officials:
affiliation: Aachen University Hospital
name: Christian Stoppe, Prof.
role: PRINCIPAL_INVESTIGATOR
References: