An interventional study of Irrigating Traumatic Wound with Drinking Water in Trauma, sponsored by Patan Academy of Health Sciences. Not yet recruiting. Per ClinicalTrials.gov, last updated 2024-03-12.
Sponsored by Patan Academy of Health Sciences · Not applicable, Interventional, and Treatment
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 0-11.5% in normal saline group and 0-12.6% in tap water group with no statistically significant difference.
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 0-11.5% in normal saline group and 0-12.6% 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.
2,217 studies on the registry are indexed under Wounds and Injuries; 441 are open to participants now.
This study's planned enrollment of 440 is above the median of 70 across 1,424 interventional studies indexed under Wounds and Injuries.
Browse Wounds and Injuries studies →Patan Academy of Health Sciences is the lead sponsor of 7 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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In drinking water arm, acute traumatic wound will be cleaned with drinking water. Bacteriological safety of the drinking water will be ensured by testing water.
Procedure: Irrigating Traumatic Wound with Drinking Water
In normal saline arm, acute traumatic wound will be cleaned with normal saline.
Procedure: Irrigating Traumatic Wound with Drinking Water
Irrigating Traumatic Wound with Drinking Water and Normal Saline
Also known as: Irrigating Traumatic Wound with Normal Saline
Comparison between drinking water and normal saline in irrigating traumatic wound: Noninferiority trial.
Difference in wound infection rates between the two randomized groups. Wound evaluation was based on the following criteria No infection: 1. No discharge or fever on day 3 2. Dry and no fever on day 7 Infection 1. Fever greater than 1000 F or pus discharge on any day 2. Erythema with serous discharge on any day
Time frame: 3-7 Days
No study locations are listed for this record.
Start is estimated for Mar 2024; primary completion for Sep 2026, 30 months later.
Of 546 non-industry interventional studies with no phase under Wounds and Injuries, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 49. This study's planned 30 months is above that.
Counting every sponsor, half of 599 studies reached it within 24 months; a quarter within 9 and three quarters within 48.
Wounds and Injuries covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Patan Academy of Health Sciences