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

Phase 3

Withdrawn

• Conditions: Chronic Wounds; Decubiti; Acute Wounds
• Interventions: Drug: Octenisept and Serasept

• Registration Number: NCT04172363
• Lead Sponsor: RWTH Aachen University

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.

Study Timeline

• Study First Submitted: 2019-11-15
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-21
• Study Start: 2020-07-22
• Primary Completion: 2021-05-22
• Study Completion: 2021-05-22
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resistance testing	Octenisept and Serasept	Patients will be first tested on resistance to Octenisept and Serasept and will receive the appropriate antiseptic after reviewing the results

Primary Outcome Measures

Name	Time	Method
Change in bacteria rate	up to 12 months	determination of the relative proportion of isolates to the total flora in the wound

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital RWTH Aachen; 🇩🇪 Aachen, NRW, Germany