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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR983 |
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Date of registration:
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28/05/2007 |
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Primary sponsor: |
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Public title:
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The effect of triclosan coated sutures in wound healing. A double blind randomized prospective pilot study.
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Scientific title:
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The effect of triclosan coated sutures in wound healing. A double blind randomized prospective pilot study in patients ondergoing a breast reduction. - N/A |
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Date of first enrolment:
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11/7/2006 |
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Target sample size:
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26 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=983 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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R.R.W.J.
Hulst, van der |
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Address:
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P. Debeyelaan 25
6202 AZ
Maastricht
The Netherlands |
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Telephone:
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+ 31 433875624 |
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Email:
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rvh@spch.azm.nl |
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Affiliation:
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Name:
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A.
Deliaert |
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Address:
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Riemsterweg 29
3740
Bilzen
Belgium |
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Telephone:
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+32 476550010 |
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Email:
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andeliaert8@hotmail.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Women between 16 and 65 years of age with bilateral breast size higher than cup DD;
2. Clinical complaints such as intertrigo, head neck and/or shoulder complaints;
3. Undergoing a breast reduction.
Exclusion criteria: 1. Patients with:
a. diabetes;
b. skin diseases;
c. history of keloid formation;
d. use of corticosteroids and other immunosuppressive medication;
e. metabolic and/or degenerative diseases.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Wound healing, Triclosan, Coated sutures, Vicryl Plus
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Intervention(s)
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Standard suture on control site;
triclosan coated suture on study site.
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Primary Outcome(s)
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Wound healing: wound dehiscence and complications are registrated.
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Secondary Outcome(s)
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Scar quality:
Colorimetric measurement 1 month after surgery Measurements are performed under standard conditions at 4 fixed test sites.
Subjective scar assessement by patients and one primary observer using the POSAS scale.
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Secondary ID(s)
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ISRCTN32724539
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N/A
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Source(s) of Monetary Support
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University Hospital Maastricht, Department of Plastic surgery
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