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The effect of triclosan coated sutures in wound healing. A double blind randomized prospective pilot study.


- candidate number2606
- NTR NumberNTR983
- ISRCTNISRCTN32724539
- Date ISRCTN created16-jul-2007
- date ISRCTN requested9-jul-2007
- Date Registered NTR28-mei-2007
- Secondary IDsN/A 
- Public TitleThe effect of triclosan coated sutures in wound healing. A double blind randomized prospective pilot study.
- Scientific TitleThe effect of triclosan coated sutures in wound healing. A double blind randomized prospective pilot study in patients ondergoing a breast reduction.
- ACRONYMN/A
- hypothesisTriclosan coated sutures might have an positive effect on wound healing and thus can improve scar quality.
- Healt Condition(s) or Problem(s) studiedWound healing, Triclosan, Coated sutures, Vicryl Plus
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 11-jul-2006
- planned closingdate11-aug-2007
- Target number of participants26
- InterventionsStandard suture on control site;
triclosan coated suture on study site.
- Primary outcomeWound healing: wound dehiscence and complications are registrated.
- Secondary outcomeScar 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.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES A. Deliaert
- CONTACT for SCIENTIFIC QUERIESDr R.R.W.J. Hulst, van der
- Sponsor/Initiator University Hospital Maastricht, Department of Plastic surgery
- Funding
(Source(s) of Monetary or Material Support)
University Hospital Maastricht, Department of Plastic surgery
- Publications
- Brief summaryWound infection is a major contributor to postoperative morbidity. One potential cause or co-factor is the use of suture material. A recently introduced subcutaneous suture is coated with triclosan (TC), an antiseptic drug. It is suggested to reduce wound complications and improve scar quality.

Methods:
To investigate the effect of TC on wound healing a double blind prospective study in women undergoing a breast reduction was performed. Each patient was her own control. After randomization the TC coated sutures were used either on the left or right side. The contra lateral side was used as the control. The incidence of dehiscence, postoperative redness and subjective parameters of scar quality were studied.
- Main changes (audit trail)
- RECORD28-mei-2007 - 9-dec-2009


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