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

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Wounds; Decubiti; Acute Wounds
• Intervention / Treatment: Drug: Octenisept and Serasept

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.

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Aachen, NRW, Germany, 52074
      • University Hospital RWTH Aachen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Care; Octenisept will be used as standard care antiseptic for dressing change
Experimental: Resistance testing; Patients will be first tested on resistance to Octenisept and Serasept and will receive the appropriate antiseptic after reviewing the results	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in bacteria rate	determination of the relative proportion of isolates to the total flora in the wound	up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of wound related adverse events	review of medical charts	up to 12 months
Change in Pressure Ulcers: Scale for Healing (PUSH) score	score 0-17; 17=big and severe wound	up to 12 months
Change in Bates-Jensen Score	Score 13-65; 13-20=minimal severity class; 41-65 extreme severity class	up to 12 months
Laboratory Parameters - Change in C-reactive protein (CRP)	mg/L	up to 12 months
Laboratory Parameters - Change in Leukocytes	10⁹/L or /nL	up to 12 months
Laboratory Parameters - Change in hemoglobin	g/dl	up to 12 months
Laboratory Parameters - Change in hematokrit		up to 12 months
Laboratory Parameters - Change in creatinine	µmol/L or mg/dl	up to 12 months
Laboratory Parameters - Change in glomerular filtration rate (GFR)	ml/min/1,73m^2	up to 12 months
Laboratory Parameters - Change in Uric acid	mg/dl	up to 12 months
Laboratory Parameters - Change in glutamic-pyruvic transaminase (GPT)	IU/L	up to 12 months
Laboratory Parameters - Change in Glutamat-Oxalacetat- Transaminase (GOT)	IU/L	up to 12 months
Laboratory Parameters - Change in Glucose	mmil/L or mg/dl	up to 12 months
Hospital length of stay	from study inclusion until hospital discharge	up to 12 months
Rate of antibiotics used	chart review	up to 12 months
Length of bed confinement	chart review	up to 12 months

Collaborators and Investigators

• Sponsor: RWTH Aachen University
• Investigators: Principal Investigator: Christian Stoppe, Prof., Aachen University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 22, 2020
• Primary Completion (Anticipated): May 22, 2021
• Study Completion (Anticipated): May 22, 2021

Study Registration Dates

• First Submitted: November 15, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Anti-Infective Agents, Local; Anti-Infective Agents; Octenidine
• Other Study ID Numbers: 17-169

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No