Comparison Between Drinking Water and Normal Saline in Irrigating Traumatic Wound: Noninferiority Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 440
- Primary Endpoint
- Comparison between drinking water and normal saline in irrigating traumatic wound: Noninferiority trial.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Irrigating Traumatic Wound with Drinking Water
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.
Intervention: Irrigating Traumatic Wound with Drinking Water (Procedure)
Irrigating Traumatic Wound with Normal Saline
In normal saline arm, acute traumatic wound will be cleaned with normal saline.
Intervention: Irrigating Traumatic Wound with Drinking Water (Procedure)
Outcomes
Primary Outcomes
Comparison between drinking water and normal saline in irrigating traumatic wound: Noninferiority trial.
Time Frame: 3-7 Days
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Ashis Shrestha
Assistant Professor
Patan Academy of Health Sciences