Home » Trials » SLCTR/2009/005
Surgical wound dressing vs non dressing
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SLCTR Registration Number
SLCTR/2009/005
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Surgical wound dressing vs non dressing
Public Title of Trial
Surgical wound dressing vs non dressing
Disease or Health Condition(s) Studied
Surgical intervention is studied
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
P13/03/2009 (Ethics Review Committee of the Faculty of Medicine, University of Kelaniya)
What is the research question being addressed?
Whether there is a difference between surgical wound dressing and non dressing after supra pubic transverse incision ?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Supportive care
Study Phase
Not Available
Intervention(s) planned
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
Inclusion criteria
All the patient who gives the consent and does not fall in the exclusion 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
Primary outcome(s)
|
1.
Surgical site complications •Wound disruption •Wound erythema • Wound discharge •Haematoma or seroma formation (To determine the occurrence of surgical site infection ) |
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Secondary outcome(s)
|
1.
Perception of post operative pain, nursing time and cosmetic appearance after 8 weeks. |
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Target number/sample size
254 (127 per group)
Countries of recruitment
Sri Lanka
Anticipated start date
2009-01-07
Anticipated end date
2010-01-01
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2009-04-28
Approval number
P13/03/2009
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. L.L.N.R.Lekamge
Registrar (Obs & Gyn)
76, Alawwa Road, Polgahawela
0777101401/ 0718258487
ravilekamge@gmail.com
Contact Person for Public Queries
Dr SFL Akbar
Consultant Obstetrician and Gynaecologist
Colombo North Teaching Hospital, Ragama
0777899239
sflakbar@gmail.com
Primary study sponsor/organization
Dr. L.L.N.R.Lekamge
76, Alawwa Road, Polgahawela
07771014012
ravilekamge@gmail.com
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
