|
Main
|
|
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. |
|
Register:
|
SLCTR |
|
Last refreshed on:
|
27 May 2013 |
|
Main ID: |
SLCTR/2009/005 |
|
Date of registration:
|
17/07/2009 |
|
Primary sponsor: |
|
|
Public title:
|
Surgical wound dressing vs non dressing
|
|
Scientific title:
|
Surgical wound dressing vs non dressing |
|
Date of first enrolment:
|
7/1/2009 |
|
Target sample size:
|
127 patients in each group(254) |
|
Recruitment status: |
Completed |
|
URL:
|
http://www.slctr.lk/trial_details.asp?reg_id={00DF7D11-4CA9-475D-830A-3C99BEBAA69A} |
|
Study type:
|
Interventional |
|
Study design:
|
Randomized controlled clinical trial
|
|
|
Countries of recruitment
|
|
Sri Lanka
| | | | | | | |
|
Contacts
|
|
Name:
|
Dr. L.L.N.R.Lekamge
|
|
Address:
|
76, Alawwa Road, Polgahawela
|
|
Telephone:
|
0777101401/0718258487 |
|
Email:
|
ravilekamge@gmail.com |
|
Affiliation:
|
Registrar (Obs and Gyn) |
|
|
Name:
|
Dr SFL Akbar
|
|
Address:
|
Colombo North Teaching Hospital, Ragama
|
|
Telephone:
|
0777899239 |
|
Email:
|
sflakbar@gmail.com |
|
Affiliation:
|
Consultant Obstetrician and Gynaecologist |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: All the patient who gives the concent and does not fall in the exclusoin criteria
Exclusion criteria: *Patients who do not give their consent to participate
*Known infection or fever at the time of surgery
*Dribbling for > 24 hours
*Previous hypertrophic scar or a keloid
*Patients currently on antibiotics or steroids
*Patient and or the surgeon preference of either method
*Immune suppressed patients or any medical condition in need of addition of antibiotics
*Emergency surgeries where there is not enough time to obtain informed consent
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
|
Surgical intervention is studied
|
|
Intervention(s)
|
|
In the group where a dressing is applied, a dressing consists of a non adherent bandage will be applied over the incision that will be covered by a bulky absorbent layer and a stretchable adhesive. (elastoplaster) and the other group will not have a dressing
|
|
Primary Outcome(s)
|
Surgical site complications
(• Wound disruption
• Wound erythema
• Wound discharge
• Haematoma or seroma formation
To determine the occurrence of surgical site infection )
|
|
Secondary Outcome(s)
|
|
Perception of post operative pain, nursing time and cosmetic appearance after 8 weeks.
|
|
Source(s) of Monetary Support
|
|
Self
|
|