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

Chronic Wounds Clinical Trial

— AntiSeptic  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04172363
• Other study ID #: 17-169
• Status: Withdrawn
• Phase: Phase 3
• Start date: July 22, 2020
• Est. completion date: May 22, 2021

Study information

• Verified date: October 2022
• Source: RWTH Aachen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 22, 2021
• Est. primary completion date: May 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Wounds
• Chronic Wounds
• Decubiti
• Wounds and Injuries

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Germany	University Hospital RWTH Aachen	Aachen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bacteria rate	determination of the relative proportion of isolates to the total flora in the wound	up to 12 months
Secondary	Incidence of wound related adverse events	review of medical charts	up to 12 months
Secondary	Change in Pressure Ulcers: Scale for Healing (PUSH) score	score 0-17; 17=big and severe wound	up to 12 months
Secondary	Change in Bates-Jensen Score	Score 13-65; 13-20=minimal severity class; 41-65 extreme severity class	up to 12 months
Secondary	Laboratory Parameters - Change in C-reactive protein (CRP)	mg/L	up to 12 months
Secondary	Laboratory Parameters - Change in Leukocytes	10?/L or /nL	up to 12 months
Secondary	Laboratory Parameters - Change in hemoglobin	g/dl	up to 12 months
Secondary	Laboratory Parameters - Change in hematokrit		up to 12 months
Secondary	Laboratory Parameters - Change in creatinine	µmol/L or mg/dl	up to 12 months
Secondary	Laboratory Parameters - Change in glomerular filtration rate (GFR)	ml/min/1,73m^2	up to 12 months
Secondary	Laboratory Parameters - Change in Uric acid	mg/dl	up to 12 months
Secondary	Laboratory Parameters - Change in glutamic-pyruvic transaminase (GPT)	IU/L	up to 12 months
Secondary	Laboratory Parameters - Change in Glutamat-Oxalacetat- Transaminase (GOT)	IU/L	up to 12 months
Secondary	Laboratory Parameters - Change in Glucose	mmil/L or mg/dl	up to 12 months
Secondary	Hospital length of stay	from study inclusion until hospital discharge	up to 12 months
Secondary	Rate of antibiotics used	chart review	up to 12 months
Secondary	Length of bed confinement	chart review	up to 12 months