Classical versus Modern Local Wound Care in Surgical Patients: A Randomized Controlled Trial
| ISRCTN | ISRCTN56264738 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN56264738 |
| Protocol serial number | IBC15010, NL492, NTR534 |
| Sponsor | Academic Medical Center (AMC), Department of Surgery (The Netherlands) |
| Funder | M, Smith&Nephew, Johnson & Johnson, Convatec |
- Submission date
- 04/01/2006
- Registration date
- 05/01/2006
- Last edited
- 11/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M.J. Lubbers
Scientific
Scientific
Academic Medical Center (AMC), Department of Surgery
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 5662470 |
|---|---|
| m.j.lubbers@amc.uva.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Classical versus Modern Local Wound Care in Surgical Patients: A Randomized Controlled Trial |
| Study acronym | MOKUM trial |
| Study objectives | Occlusive, non-gauze based wound dressings are more effective (as to time to complete wound healing, pain during dressing changes, and costs) than non-occlusive, gauze-based dressings for local wound care. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Wound Care |
| Intervention | Occlusive wound dressing materials versus gauze dressings |
| Intervention type | Other |
| Primary outcome measure(s) |
Time to complete wound healing |
| Key secondary outcome measure(s) |
1. Pain during dressing changes |
| Completion date | 14/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 285 |
| Total final enrolment | 285 |
| Key inclusion criteria | 1. Adult patients admitted to the departments of surgery with open wounds requiring local wound care 2. Written informed consent |
| Key exclusion criteria | 1. Burn and malignant wounds 2. Surgically closed wounds 3. Wounds treated with vacuum assisted closure (VAC) devices 4. Ostomies or drain openings 5. Pin holes from external fixation materials 6. Patients receiving chemotherapy or local irradiation therapy 7. Patients with a life expectancy <6 months |
| Date of first enrolment | 23/04/2004 |
| Date of final enrolment | 14/09/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center (AMC), Department of Surgery
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2008 | 11/01/2021 | Yes | No |
Editorial Notes
11/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.
