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

NCT04172363 | Withdrawn Phase 3

• 1 other identifier: 17-169
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Decubiti; Chronic Wounds; Acute Wounds

Outcome Measures

Primary Outcomes (1)

• Change in bacteria rate

  determination of the relative proportion of isolates to the total flora in the wound

  up to 12 months

Secondary Outcomes (16)

• Incidence of wound related adverse events

  up to 12 months

• Change in Pressure Ulcers: Scale for Healing (PUSH) score

  up to 12 months

• Change in Bates-Jensen Score

  up to 12 months

• Laboratory Parameters - Change in C-reactive protein (CRP)

  up to 12 months

• Laboratory Parameters - Change in Leukocytes

  up to 12 months

Study Arms (2)

Standard Care

NO INTERVENTION

Octenisept will be used as standard care antiseptic for dressing change

Resistance testing

EXPERIMENTAL

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

Interventions

Octenisept and Serasept 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

Resistance testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Decubitus OR secondary healing acute and chronic wounds
• Positively tested wound swab for bacteria (incl. multi-resistant bacteria)
• Patient is capable of understanding the nature, significance and consequence of the clinical trial
• Given written consent
• Women of child bearing potential (WOCBP) who apply appropriate methods of contraception throughout the duration of the study

You may not qualify if:

• Occlusive dressing (e.g. VAC) or Negative Pressure Wound Therapy (NPWT)
• Pregnant or lactating women
• Known allergies against investigational products

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

University Hospital RWTH Aachen

Aachen, North Rhine-Westphalia, 52074, Germany

Location

MeSH Terms

Conditions

Pressure Ulcer

Interventions

octenidine and phenoxyethanol drug combination

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Christian Stoppe, Prof.

  Aachen University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is monocentric, prospective, controlled, open, randomized, 2-armed interventional pilot trial.

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 21, 2019
• Study Start: July 22, 2020
• Primary Completion: May 22, 2021
• Study Completion: May 22, 2021
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)