Acute Wounds, Chronic Wounds, Decubiti
Conditions
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.
Interventions
DRUGOctenisept 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
Sponsors
RWTH Aachen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is monocentric, prospective, controlled, open, randomized, 2-armed interventional pilot trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in bacteria rate | up to 12 months | determination of the relative proportion of isolates to the total flora in the wound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Incidence of wound related adverse events | up to 12 months | review of medical charts |
| 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 |
| Laboratory Parameters - Change in glomerular filtration rate (GFR) | up to 12 months | ml/min/1,73m\^2 |
Countries
Germany
Outcome results
None listed