Condition category
Surgery
Date applied
08/06/2009
Date assigned
09/07/2009
Last edited
11/02/2010
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 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

Sponsor information

Organisation

Dr. Lutfi Kirdar Kartal Research and Training Hospital (Turkey)

Sponsor details

c/o Dr Mehmet Murat Naki
Cihat Saran Sk. Cagdas Apt. No:11/3
Kucukyali Maltepe
Istanbul
34841
Turkey

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes