Comparison Between Drinking Water and Normal Saline in Irrigating Traumatic Wound
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Irrigating Traumatic Wound with Drinking Water.
- Who it may be relevant to
- Registry conditions: Trauma. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparison Between Drinking Water and Normal Saline in Irrigating Traumatic Wound: Noninferiority Trial
Overview
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.
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 0-11.5% 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.
Interventions
- Procedure Irrigating Traumatic Wound with Drinking Water
Irrigating Traumatic Wound with Drinking Water and Normal Saline
Primary outcome measures
- Comparison between drinking water and normal saline in irrigating traumatic wound: Noninferiority trial. [Time frame: 3-7 Days]
Eligibility criteria
Inclusion criteria
- Laceration wound presenting within 6 hours of duration
- Lacerations involving upper and lower limbs, scalps, head and neck
Exclusion criteria
- Lacerations involving, lips, ears, mucosal surface, perineal and peri anal region
- Punctured or penetrating wound
- Bite wounds by human or animals or snakes
- Dirty wound requiring surgical debridement
- Patient requiring irrigation of wound with more than 1 liter of fluid
- Wounds involving tendon, joint or bone
- Wound associated with open fracture
- Patient on corticosteroid, antibiotics or immunosuppressant
- Patient who are not able to come for follow-up
- Immunocompromised patient
- Patient with history of significant peripheral vascular disease
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06304272 · Irrigation