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Classical vs. Modern Local Wound Care in Surgical Patients: A Randomized Controlled Trial.


- candidate number1908
- NTR NumberNTR534
- ISRCTNISRCTN56264738
- Date ISRCTN created5-jan-2006
- date ISRCTN requested3-jan-2006
- Date Registered NTR30-dec-2005
- Secondary IDsIBC15010 
- Public TitleClassical vs. Modern Local Wound Care in Surgical Patients: A Randomized Controlled Trial.
- Scientific TitleClassical vs. Modern Local Wound Care in Surgical Patients: A Randomized Controlled Trial.
- ACRONYMMOKUM trial
- hypothesisOcclusive, 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) studiedWound care
- Inclusion criteria1. Adult patients admitted to the departments of surgery with open wounds requiring local wound care.
2. Written informed consent.
- Exclusion criteria1. 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 23-apr-2004
- planned closingdate14-sep-2005
- Target number of participants285
- InterventionsOcclusive wound dressing materials vs. gauze dressings.
- Primary outcomeTime to complete wound healing.
- Secondary outcome1. Pain during dressing changes, material and nursing costs of dressing changes;
2. Duration of hospitalisation;
3. Adverse effects of dressings.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. M.J. Lubbers
- CONTACT for SCIENTIFIC QUERIESDr. 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
- Publications1. 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 summaryLocal 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)
- RECORD30-dec-2005 - 11-sep-2008


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