Home » Trials » SLCTR/2014/035
Randomized, double blind, controlled study on efficacy and overall impact on wound healing of acetic acid and ascorbic acid as antiseptics in chronic diabetic wounds
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SLCTR Registration Number
SLCTR/2014/035
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Randomized, double blind, controlled study on efficacy and overall impact on wound healing of acetic acid and ascorbic acid as antiseptics in chronic diabetic wounds
Public Title of Trial
Efficacy and overall impact on wound healing of acetic acid and ascorbic acid as antiseptics in chronic diabetic wounds
Disease or Health Condition(s) Studied
Chronic diabetic wounds
Scientific Acronym
None
Public Acronym
None
Brief title
Role of antiseptics in chronic wound management
Universal Trial Number
U1111-1159-7983
Any other number(s) assigned to the trial and issuing authority
39/14 (University of Sri Jayawardenepura)
What is the research question being addressed?
Is ascorbic acid a better antiseptic than conventionally used acetic acid or normal saline in the management of chronic diabetic wounds?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Applicable
Intervention(s) planned
Participants will be recruited from in-ward patients as well as patients attending the wound clinics of the Colombo South Teaching Hospital. Consenting participants will be randomized into three arms. either 0.5% acetic acid (arm A), 0.5% ascorbic acid (arm B) or 0.9% saline (arm C).
Following initial assessment, cleaning, and swabbing the relevant antiseptic solution will be applied in a amount adequate to soak the wound. The wound will be managed according to standard protocols, with the same antiseptic solution being applied every other day for 1 week.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Wound healing according to PEDIS score (Perfusion, Extent/size, Depth/tissue loss, Infection, and Sensation) and an objective wound assessment questionnaire |
[ At baseline, at the end of one week and at the end of 1 month ] |
Secondary outcome(s)
|
1.
|
[ Both secondary outcomes will be assessed at the following time points. Day 1: Pre swab (prior to antiseptic instillation), 10 minutes after instillation, 1 hour after instillation, 4 hours after instillation Day 3: Pre swab (prior to antiseptic instillation), 10 minutes after instillation, 1 hour after instillation, 4 hours after instillation At the end of one month ] |
Target number/sample size
174 (58 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2015-01-01
Anticipated end date
2015-12-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2014-07-17
Approval number
39/14
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura |
| Institutional Address: | Gangodawila, Nugegoda Sri Lanka |
| Telephone: | +94-112758000 (Extension: 4075) |
| Email: | erc.fms.usjp@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Thilina Samarasinghe
Department of Surgery, Faculty of Medical Sciences, University of Sri Jayewardenepura.
Tel: +94 -011- 2858660
Mob: +94-773-817660
Fax: +94 -11-2810480
thilinasam@gmail.com
Contact Person for Public Queries
Prof. Aloka Pathirana
Professor in Surgery
Department of Surgery, Faculty of Medical Sciences, University of Sri Jayewardenepura.
Tel: +94 -011- 2858660
Mob: +94-77-7393003
Fax: +94 -11-2810480
aloka@sltnet.lk
Primary study sponsor/organization
Department of Surgery
Faculty of Medical Sciences,
University of Sri Jayewardenepura,
Sri Lanka
Tel: +94 -011- 2858660
Fax: +94 -11-2810480
http://www.sjp.ac.lk/fms/index.php/about-the-faculty-home/departments/department-of-surgery
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
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
