Clinical trial NCT06304272: Comparison Between Drinking Water and Normal Saline in Irrigating Traumatic Wound
Official title: Comparison Between Drinking Water and Normal Saline in Irrigating Traumatic Wound: Noninferiority Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Trauma
Keywords: Traumatic Wound
Wound Infection
Lead sponsor: Patan Academy of Health Sciences
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 440
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double blinded, parallel, non-inferiority trial
Primary purpose: TREATMENT

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 0-11.5% 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.

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

Primary outcomes:
measure: Comparison between drinking water and normal saline in irrigating traumatic wound: Noninferiority trial.
timeFrame: 3-7 Days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Patan Academy of Health Sciences
name: Ashis Shrestha, Fellow
role: PRINCIPAL_INVESTIGATOR
References: