Condition category
Injury, Occupational Diseases, Poisoning
Date applied
16/07/2007
Date assigned
16/07/2007
Last edited
16/07/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr A. Deliaert

ORCID ID

Contact details

Riemsterweg 29
Bilzen
3740
Belgium
+32 (0)4 7655 0010
andeliaert8@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Triclosan coated sutures might have an positive effect on wound healing and thus can improve scar quality.

Ethics approval

Not provided at time of registration

Study design

Randomised, double blinded, active controlled, parallel group, trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Coated sutures, triclosan, vicryl plus, wound healing

Intervention

Standard suture on control site versus triclosan coated suture on study site.

Intervention type

Drug

Phase

Not Specified

Drug names

Triclosan coated sutures

Primary outcome measures

Wound healing:
Wound dehiscence and complications are registered.

Secondary outcome measures

Scar quality:
1. Colorimetric measurement one month after surgery. Measurements are performed under standard conditions at four fixed test sites
2. Subjective scar assessment by patients and one primary observer using the Patient and Observer Scar Assessment Scale (POSAS)

Overall trial start date

11/07/2006

Overall trial end date

11/08/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

26

Participant exclusion criteria

Patients with:
1. Diabetes
2. Skin diseases
3. History of keloid formation
4. Use of corticosteroids and other immunosuppressive medication
5. Metabolic and/or degenerative diseases

Recruitment start date

11/07/2006

Recruitment end date

11/08/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Riemsterweg 29
Bilzen
3740
Belgium

Sponsor information

Organisation

University Hospital Maastricht (The Netherlands)

Sponsor details

Department of Plastic Surgery
Maastricht
6200 MD
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.unimaas.nl/

Funders

Funder type

Hospital/treatment centre

Funder name

University Hospital Maastricht (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes