Faster wound healing with topical negative pressure therapy in difficult to heal wounds
| ISRCTN | ISRCTN36051617 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36051617 |
| Secondary identifying numbers | 2003-263 CMO |
- Submission date
- 31/05/2009
- Registration date
- 24/07/2009
- Last edited
- 24/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Erik de Laat
Scientific
Scientific
Radboud University Nijmegen Medical Centre
926 Plastic Surgery
PO Box 9101
Nijmegen
6500 HB
Netherlands
| Phone | +31 (0)6 533 55 278 |
|---|---|
| e.delaat@plchir.umcn.nl |
Study information
| Study design | Prospective stratified randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Faster wound healing with topical negative pressure therapy in difficult to heal wounds: a prospective randomised controlled trial |
| Study objectives | 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(s) | Committee on Research Involving Human Subjects, Arnhem Nijmegen approved on the 24th January 2003 (ref: 2003-263 CMO) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/03/2003 |
| Completion date | 01/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 24 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2003 |
| Date of final enrolment | 01/03/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Radboud University Nijmegen Medical Centre
Nijmegen
6500 HB
Netherlands
6500 HB
Netherlands
Sponsor information
Radboud University Nijmegen Medical Centre (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
690 Department of Surgery
PO Box 9101
Nijmegen
6500 HB
Netherlands
| Phone | +31 (0)2 436 16 421 |
|---|---|
| H.vanGoor@CHIR.umcn.nl | |
| Website | http://www.umcn.nl/scientist/afdelingen/heelkunde?actieve_tab=scientist |
"ROR" |
https://ror.org/05wg1m734 |
Funders
Funder type
Hospital/treatment centre
Radboud University Nijmegen Medical Centre (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
