TraumaNCT06304272
Comparison Between Drinking Water and Normal Saline in Irrigating Traumatic Wound
A study testing Irrigating Traumatic Wound with Drinking Water in people with Trauma, run by Patan Academy of Health Sciences.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trauma
- What is being tested?
- Irrigating Traumatic Wound with Drinking Water
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 440 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Laceration wound presenting within 6 hours of duration
- Lacerations involving upper and lower limbs, scalps, head and neck
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison Between Drinking Water and Normal Saline in Irrigating Traumatic Wound: Noninferiority Trial
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.
Read the 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.
- Conditions
- Trauma
- Being tested
- Irrigating Traumatic Wound with Drinking Water
- Keywords
- Traumatic Wound, Wound Infection
- Medical subject headings
- Wounds and Injuries, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irrigating Traumatic Wound with Drinking WaterProcedure or surgery
Also called Irrigating Traumatic Wound with Normal Saline
Irrigating Traumatic Wound with Drinking Water and Normal Saline
| Study group | Role | What they receive |
|---|---|---|
| Irrigating Traumatic Wound with Drinking Water | Experimental | 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. Receives: Procedure: Irrigating Traumatic Wound with Drinking Water |
| Irrigating Traumatic Wound with Normal Saline | Experimental | In normal saline arm, acute traumatic wound will be cleaned with normal saline. Receives: Procedure: Irrigating Traumatic Wound with Drinking Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- No discharge or fever on day 3
- Dry and no fever on day 7 Infection
- Fever greater than 1000 F or pus discharge on any day 2. Erythema with serous discharge on any day
Measured: 3-7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double blinded, parallel, non-inferiority trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Patan Academy of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashis Shrestha, Patan Academy of Health Sciences
- Investigators
- Ashis Shrestha, Fellow, Principal investigator, Patan Academy of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304272
- Sponsor's protocol ID
- Irrigation
- Status last verified
- Mar 2024
- First submitted
- 20 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Drinking Water and Normal Saline in Irrigating Traumatic Wound: Noninferiority Trial
- ClinicalTrials.gov ID
- NCT06304272
- Acronym / sponsor ID
- Irrigation
- Conditions
- Trauma
- Keywords
- Traumatic Wound, Wound Infection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Patan Academy of Health SciencesUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized, double blinded, parallel, non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| Irrigating Traumatic Wound with Drinking Water | Experimental | Procedure: Irrigating Traumatic Wound with Drinking WaterIn drinking water arm, acute traumatic wound will be cleaned with drinking water. Bacteriological safety of the drinking water will be ensured by testing water. |
| Irrigating Traumatic Wound with Normal Saline | Experimental | Procedure: Irrigating Traumatic Wound with Drinking WaterIn normal saline arm, acute traumatic wound will be cleaned with normal saline. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Laceration wound presenting within 6 hours of duration
- Lacerations involving upper and lower limbs, scalps, head and neck
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irrigating Traumatic Wound with Drinking WaterAlso: Irrigating Traumatic Wound with Normal SalineIrrigating Traumatic Wound with Drinking Water and Normal Saline | Procedure or surgery | Irrigating Traumatic Wound with Drinking Water, Irrigating Traumatic Wound with Normal Saline |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- The Effects of Wound Lavage Solutions on Canine Fibroblasts: An In Vitro StudyLink provided by the sponsor.
- The importance of lavage in wound careLink provided by the sponsor.
- Is tap water a safe alternative to normal saline for wound irrigation in the community setting?Link provided by the sponsor.
- Water is a safe and effective alternative to sterile normal saline for wound irrigation prior to suturing: a prospective, double-blind, randomised, controlled clinical trialLink provided by the sponsor.
- The effectiveness of cleansing solution for wound treatment A systematic reviewLink provided by the sponsor.
- Comparison of wounds' infection rate between tap water and normal saline cleansing: A meta-analysis of randomised control trialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashis Shrestha, Fellow principal investigator
Patan Academy of Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Irrigating Traumatic Wound with Drinking Water in people with Trauma, run by Patan Academy of Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashis Shrestha, Fellow (9851061846, ashisshrestha@pahs.edu.np), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison between drinking water and normal saline in irrigating traumatic wound: Noninferiority trial. (time frame: 3-7 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.