Contact information
Type
Scientific
Primary contact
Dr Mehmet Murat Naki
ORCID ID
Contact details
Cihat Saran Sk. Cagdas Apt. No:11/3
Kucukyali Maltepe
Istanbul
34841
Turkey
mmuratnaki@yahoo.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Comparative study of a barbed suture, polyglecaprone and stapler in Pfannenstiel incisions performed for benign gynaecological procedures: a randomised trial
Acronym
Study hypothesis
Are there any differences between three suture materials on post-operative incision pain, patient satisfaction and scar cosmesis?
Please note that as of 11/02/10 this trial has been updated to included participants aged 18-65.
Ethics approval
Ethics Committee of the Dr. Lutfi Kirdar Kartal Research and Training Hospital approved on the 26th March 2009 (ref: 17/28.05.2009)
Study design
Randomised controlled single centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Benign gynaecological diseases/skin incision closure
Intervention
This trial is taking place at the Istanbul Dr. Lutfi Kirdar Kartal Research and Training Hospital, Department of Obstetrics and Gynaecology. Approximately 117 patients will be recruited, 39 patients in each of the following three groups:
1. Skin incision closure with a barbed suture (copolymer of glycolide and e-caprolactone)
2. Skin incision closure with intracutaneous polyglecaprone
3. Skin incision closure with stapler
Patient allocation will be carried out as follows:
A computer based randomisation will be prepared. The skin closure type will be printed on identical sheets of paper, which will be put into identical, consecutively numbered sealed opaque envelopes by a non-participating colleague.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
1. Pain for skin incision (post-operative third day)
Secondary outcome measures
1. Patient satisfaction (post-operative sixth day)
2. Scar cosmesis score (post-operative third month)
Overall trial start date
01/06/2009
Overall trial end date
31/12/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Women between ages of 18 - 45 years
2. Pfannenstiel incisions for benign gynaecological procedures
3. No previous lower abdominal incision
Amended 11/02/10:
1. Women between ages of 18 - 65 years
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Approximately 117
Participant exclusion criteria
1. Previous lower abdominal incision
2. Diabetes mellitus
3. Body mass index more than 35 kg/m^2
4. Chronic alcholism
Recruitment start date
01/06/2009
Recruitment end date
31/12/2009
Locations
Countries of recruitment
Turkey
Trial participating centre
Cihat Saran Sk. Cagdas Apt. No:11/3
Istanbul
34841
Turkey
Funders
Funder type
Hospital/treatment centre
Funder name
Dr. Lutfi Kirdar Kartal Research and Training Hospital (Turkey) - Department of Obstetrics and Gynaecology
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