Contact information
Type
Scientific
Primary contact
Dr Erik de Laat
ORCID ID
Contact details
Radboud University Nijmegen Medical Centre
926 Plastic Surgery
PO Box 9101
Nijmegen
6500 HB
Netherlands
+31 (0)6 533 55 278
e.delaat@plchir.umcn.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2003-263 CMO
Study information
Scientific title
Faster wound healing with topical negative pressure therapy in difficult to heal wounds: a prospective randomised controlled trial
Acronym
Study hypothesis
This study aimed to investigate the effectiveness and safety of topical negative pressure therapy, compared with conventional dressing therapy in patients with difficult to heal wounds of various aetiologies and particularly in spinal cord injury (SCI) patients with pressure ulcers.
Ethics approval
Committee on Research Involving Human Subjects, Arnhem Nijmegen approved on the 24th January 2003 (ref: 2003-263 CMO)
Study design
Prospective stratified randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Difficult to heal wounds of various aetiologies
Intervention
Patients randomly assigned to topical negative pressure therapy received a treatment with the VAC-system™ (Vacuum-Assisted Closure; KCI USA, San Antonio, TX, USA). According to manufacturer's instructions for use, the foam dressings and the TRAC Pad® were changed three times a week (Monday morning, Wednesday and Friday in the afternoon). The fluid connection system was changed at least once a week. Patients randomly assigned to the control group received treatment with a sodium hypochlorite 0.25% solution. This wet-to-moist dressing was changed two to three times a day, depending on the wound debris.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Time to 50% wound volume reduction, with a maximum follow-up time of six weeks. This point was determined by measuring the difference between the weekly measured wound volume and the initial wound volume before treatment.
Secondary outcome measures
1. Wound healing failure rates, defined as any deterioration of the wound that necessitated changing the treatment protocol to which patient was assigned
2. Any adverse event, defined as any unfavourable and unintended diagnosis, symptom, sign, syndrome, or disease that either arose during the study, or seemed to deteriorate, if present at baseline
Wound healing failure and adverse events were only diagnosed as such after confirmation by an independent physician.
Overall trial start date
01/03/2003
Overall trial end date
01/03/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged greater than or equal to 18 years, either sex
2. Difficult to heal surgical wounds (i.e. dehisced abdominal wounds, complex pilonidal sinus, infected wounds and pressure ulcers)
3. Paraplegic and tetraplegic patients with pressure ulcers grade IV according to the European Pressure Ulcer Advisory Panel grading system
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
24
Participant exclusion criteria
1. Untreated osteomyelitis
2. A life expectation less than one year
3. Radiation or chemical exposure
4. Pregnant or lactating females
5. Not able to comply to one of the interventions
6. Treated with one of the study treatments in the past 30 days
Recruitment start date
01/03/2003
Recruitment end date
01/03/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Radboud University Nijmegen Medical Centre
Nijmegen
6500 HB
Netherlands
Sponsor information
Organisation
Radboud University Nijmegen Medical Centre (Netherlands)
Sponsor details
690 Department of Surgery
PO Box 9101
Nijmegen
6500 HB
Netherlands
+31 (0)2 436 16 421
H.vanGoor@CHIR.umcn.nl
Sponsor type
Hospital/treatment centre
Website
http://www.umcn.nl/scientist/afdelingen/heelkunde?actieve_tab=scientist
Funders
Funder type
Hospital/treatment centre
Funder name
Radboud University Nijmegen Medical Centre (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary