Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06304272
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-12
First Post:
2024-02-20
Brief Title:
Comparison Between Drinking Water and Normal Saline in Irrigating Traumatic Wound
Sponsor:
Patan Academy of Health Sciences
Organization:
Patan Academy of Health Sciences
Study Overview
Official Title:
Comparison Between Drinking Water and Normal Saline in Irrigating Traumatic Wound Noninferiority Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There is a controversy regarding the roles of the Normal saline and Tap water in irrigation of the wound It has been suggested that antiseptic solution including normal saline has cytotoxic effect while tap water damages the fibroblast There are no high level evidence to support one type of solution over other systematic review have found no difference in wound infection between irrigation with normal saline vs tap water There are ten randomized controlled trial comparing tap water with normal saline for irrigating wound published between 1992 to 2016 These RCT are analyzed in three systemic review and meta-analysis published on 2016 2019 2022 which showed that tap water and normal saline has no difference in terms of infection rate The infection rate observed in various studies ranges from 0-115 in normal saline group and 0-126 in tap water group with no statistically significant difference
Detailed Description:
There is a controversy regarding the roles of the Normal saline and Tap water in irrigation of the wound It has been suggested that antiseptic solution including normal saline has cytotoxic effect while tap water damages the fibroblast There are no high level evidence to support one type of solution over other systematic review have found no difference in wound infection between irrigation with normal saline vs tap water There are ten randomized controlled trial comparing tap water with normal saline for irrigating wound published between 1992 to 2016 These RCT are analyzed in three systemic review and meta-analysis published on 2016 2019 2022 which showed that tap water and normal saline has no difference in terms of infection rate The infection rate observed in various studies ranges from 0-115 in normal saline group and 0-126 in tap water group with no statistically significant difference
The published study has looked into tap water which may not be equivalent to drinking water in our setup therefore the investigators are looking into drinking water that is bacteriologically safe Out of published RCTs there is only one done in acute traumatic wound with good sample size and study design This study is purposed to look into acute traumatic wound with proper randomization allocation and concealment Moreover this is a non-inferiority trial therefore if it is proven that drinking water is non-inferior to normal saline then it will be easily available modality of wound irrigation in Low-Middle-Income country like Nepal
The published study has looked into tap water which may not be equivalent to drinking water in our setup therefore the investigators are looking into drinking water that is bacteriologically safe Out of published RCTs there is only one done in acute traumatic wound with good sample size and study design This study is purposed to look into acute traumatic wound with proper randomization allocation and concealment Moreover this is a non-inferiority trial therefore if it is proven that drinking water is non-inferior to normal saline then it will be easily available modality of wound irrigation in Low-Middle-Income country like Nepal
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None