Comparison Between Drinking Water and Normal Saline in Irrigating Traumatic Wound

Patan Academy of Health Sciences

Status: Not yet enrolling

Conditions: Trauma

Treatments: Procedure: Irrigating Traumatic Wound with Drinking Water

Study type: Interventional

Funder types: Other

Identifiers

NCT06304272

Irrigation

Details and patient eligibility

About

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.

Full 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.

Enrollment: 440 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

440 participants in 2 patient groups

Irrigating Traumatic Wound with Drinking Water

Experimental group

Description:

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.

Treatment:

Procedure: Irrigating Traumatic Wound with Drinking Water

Irrigating Traumatic Wound with Normal Saline

Experimental group

Description:

In normal saline arm, acute traumatic wound will be cleaned with normal saline.

Treatment:

Procedure: Irrigating Traumatic Wound with Drinking Water