| - candidate number | 1908 |
| - NTR Number | NTR534 |
| - ISRCTN | ISRCTN56264738 |
| - Date ISRCTN created | 5-jan-2006 |
| - date ISRCTN requested | 3-jan-2006 |
| - Date Registered NTR | 30-dec-2005 |
| - Secondary IDs | IBC15010 |
| - Public Title | Classical vs. Modern Local Wound Care in Surgical Patients: A Randomized Controlled Trial. |
| - Scientific Title | Classical vs. Modern Local Wound Care in Surgical Patients: A Randomized Controlled Trial. |
| - ACRONYM | MOKUM trial |
| - hypothesis | 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. |
| - Healt Condition(s) or Problem(s) studied | Wound care |
| - Inclusion criteria | 1. Adult patients admitted to the departments of surgery with open wounds requiring local wound care. 2. Written informed consent. |
| - 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. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Single |
| - control | Active |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 23-apr-2004 |
| - planned closingdate | 14-sep-2005 |
| - Target number of participants | 285 |
| - Interventions | Occlusive wound dressing materials vs. gauze dressings. |
| - Primary outcome | Time to complete wound healing. |
| - Secondary outcome | 1. Pain during dressing changes,
material and nursing costs of dressing changes; 2. Duration of hospitalisation; 3. Adverse effects of dressings. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | stopped: trial finished |
| - CONTACT FOR PUBLIC QUERIES | Dr. M.J. Lubbers |
| - CONTACT for SCIENTIFIC QUERIES | Dr. D.T. Ubbink |
| - Sponsor/Initiator | Academic Medical Center (AMC), Department of Surgery |
| - Funding (Source(s) of Monetary or Material Support) | Johnson & Johnson, Smith & Nephew, Convatec, 3M |
| - Publications | 1. Wounds 2006;18(10):286-93. 2. Wound Repair Regen. 2007 May-Jun;15(3):302-7. 3. J Clin Nurs. 2007 Jul;16(7):1270-7. 4. J Clin Nurs. 2008 Mar;17(5):593-601. 5. Arch Surg 2008 Oct; in press. |
| - Brief summary | Local wound care is a worldwide challenge. The large variety in dressing materials and the lack of convincing evidence make the choice for the optimum dressing for open wounds cumbersome, which hampers optimum wound care. This randomised trial was conducted to obtain the first high-level evidence on the costs and effectiveness of the occlusive wound care principle as compared to the classical approach using non-occlusive gauze dressings for local wound care. |
| - Main changes (audit trail) | |
| - RECORD | 30-dec-2005 - 11-sep-2008 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl