DecubitiPhase 3AntiSepticNCT04172363
Clinical Relevance of the Antimicrobial Resistance Testing in the Treatment of Chronic Wounds With Antiseptics
A Phase 3 study testing Octenisept and Serasept in people with Decubiti and Chronic Wounds, run by RWTH Aachen University at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decubiti, Chronic Wounds, Acute Wounds
- What is being tested?
- Octenisept and Serasept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 22 Jul 2020to 22 May 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Occlusive dressing (e.g. VAC) or Negative Pressure Wound Therapy (NPWT)
- Pregnant or lactating women
- Known allergies against investigational products
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
About this study
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.
Read the 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.
- Conditions
- Decubiti, Chronic Wounds, Acute Wounds
- Being tested
- Octenisept and Serasept
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octenisept and SeraseptDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Octenisept and Serasept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bacteria rate
determination of the relative proportion of isolates to the total flora in the wound
Measured: up to 12 months
Secondary outcomes (16)
Incidence of wound related adverse events
review of medical charts
Measured: up to 12 months
Change in Pressure Ulcers: Scale for Healing (PUSH) score
score 0-17; 17=big and severe wound
Measured: up to 12 months
Change in Bates-Jensen Score
Score 13-65; 13-20=minimal severity class; 41-65 extreme severity class
Measured: up to 12 months
Laboratory Parameters - Change in C-reactive protein (CRP)
mg/L
Measured: up to 12 months
Laboratory Parameters - Change in Leukocytes
10⁹/L or /nL
Measured: up to 12 months
Laboratory Parameters - Change in hemoglobin
g/dl
Measured: up to 12 months
Laboratory Parameters - Change in hematokrit
Measured: up to 12 months
Laboratory Parameters - Change in creatinine
µmol/L or mg/dl
Measured: up to 12 months
Laboratory Parameters - Change in glomerular filtration rate (GFR)
ml/min/1,73m^2
Measured: up to 12 months
Laboratory Parameters - Change in Uric acid
mg/dl
Measured: up to 12 months
Laboratory Parameters - Change in glutamic-pyruvic transaminase (GPT)
IU/L
Measured: up to 12 months
Laboratory Parameters - Change in Glutamat-Oxalacetat- Transaminase (GOT)
IU/L
Measured: up to 12 months
Laboratory Parameters - Change in Glucose
mmil/L or mg/dl
Measured: up to 12 months
Hospital length of stay
from study inclusion until hospital discharge
Measured: up to 12 months
Rate of antibiotics used
chart review
Measured: up to 12 months
Length of bed confinement
chart review
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start22 Jul 2020 (estimated)
- Primary completion22 May 2021 (estimated)
- Study completion22 May 2021 (estimated)
Why it stopped: PI left site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DecubitiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is monocentric, prospective, controlled, open, randomized, 2-armed interventional pilot trial.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Stoppe, Prof., Principal investigator, Aachen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172363
- Sponsor's protocol ID
- 17-169
- Acronym
- AntiSeptic
- Status last verified
- Oct 2022
- First submitted
- 15 Nov 2019
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Relevance of the Antimicrobial Resistance Testing in the Treatment of Chronic Wounds With Antiseptics
- ClinicalTrials.gov ID
- NCT04172363
- Acronym / sponsor ID
- AntiSeptic / 17-169
- Conditions
- Decubiti, Chronic Wounds, Acute Wounds
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left site
- Enrolment
- 0 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 22 Jul 2020 (estimated)
- Primary completion
- 22 May 2021 (estimated)
- Study completion
- 22 May 2021 (estimated)
- First posted
- 21 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is monocentric, prospective, controlled, open, randomized, 2-armed interventional pilot trial.
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Octenisept will be used as standard care antiseptic for dressing change |
| Resistance testing | Experimental | Drug: Octenisept and SeraseptPatients will be first tested on resistance to Octenisept and Serasept and will receive the appropriate antiseptic after reviewing the results |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Occlusive dressing (e.g. VAC) or Negative Pressure Wound Therapy (NPWT)
- Pregnant or lactating women
- Known allergies against investigational products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Octenisept and SeraseptSwab 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 | Drug | Resistance testing |
Primary outcome
Change in bacteria rate
Time frame: up to 12 months
determination of the relative proportion of isolates to the total flora in the wound
16 secondary outcomes
Incidence of wound related adverse events
Time frame: up to 12 months
Change in Pressure Ulcers: Scale for Healing (PUSH) score
Time frame: up to 12 months
Change in Bates-Jensen Score
Time frame: up to 12 months
Laboratory Parameters - Change in C-reactive protein (CRP)
Time frame: up to 12 months
Laboratory Parameters - Change in Leukocytes
Time frame: up to 12 months
Laboratory Parameters - Change in hemoglobin
Time frame: up to 12 months
Laboratory Parameters - Change in hematokrit
Time frame: up to 12 months
Laboratory Parameters - Change in creatinine
Time frame: up to 12 months
Laboratory Parameters - Change in glomerular filtration rate (GFR)
Time frame: up to 12 months
Laboratory Parameters - Change in Uric acid
Time frame: up to 12 months
Laboratory Parameters - Change in glutamic-pyruvic transaminase (GPT)
Time frame: up to 12 months
Laboratory Parameters - Change in Glutamat-Oxalacetat- Transaminase (GOT)
Time frame: up to 12 months
Laboratory Parameters - Change in Glucose
Time frame: up to 12 months
Hospital length of stay
Time frame: up to 12 months
Rate of antibiotics used
Time frame: up to 12 months
Length of bed confinement
Time frame: up to 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Stoppe, Prof. principal investigator
Aachen University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Octenisept and Serasept in people with Decubiti and Chronic Wounds, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in bacteria rate (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022; AzTrials last refreshed its copy on 8 Nov 2026.