The Irrigation or No Irrigation in Simple Lacerations Trials

NCT02976480 | Recruiting

• 1 other identifier: 2016-025
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether the irrigation or non-irrigation of a simple laceration treated in the emergency department has an effect on the subsequent rate of infection.

Conditions

Laceration - Injury; Infection

Keywords

Irrigation

Outcome Measures

Primary Outcomes (1)

• Laceration infection following repair

  The primary outcome measured will be the 30-day post-repair infection rate in both study groups. At 30 days post-repair, patients will be contacted by phone by a trained nurse. A standardized form will be used to collect relevant information. Patients will be asked whether they consulted a physician for a wound infection, and if antibiotics or drainage was required. An infected wound is defined as one requiring either drainage or antibiotic treatment by the assessing physician. The regional Medical Electronic Record will be reviewed for patients that were lost at follow up. Records of subsequent visits for wound infection will be looked for at 30 days post-repair.

  At 30 days post-repair

Secondary Outcomes (2)

• Laceration infections following repair

  At 5 to 10 days post-repair

• Aesthetic appearance of the laceration following repair

  At 30 days post-repair

Study Arms (2)

Irrigation

ACTIVE COMPARATOR

The subjects randomized to this group will have their simple lacerations irrigated with a normal saline solution.

Procedure: Irrigation

No Irrigation

EXPERIMENTAL

The subjects randomized to this group will not have their simple lacerations directly irrigated with a normal saline solution.

Procedure: No irrigation

Interventions

Irrigation PROCEDURE

A designated unblinded medical team member (nurse, emergency room physician or resident/trainee uninvolved in that particular patient's care) will prepare the laceration for repair and perform the irrigation. Irrigation will be delivered through a 20 Gauge 1 inch long catheter mounted on a 60 millilitre syringe. The volume of normal saline used will be calculated as 60 millilitre per centimetre length of laceration for a maximum of 300 millilitre. Once completed, the treating physician will enter the room and proceed to the laceration closure with the method and equipment of his choice. Both the patient (through eye covering) and the treating physician will remain blinded to the intervention.

Irrigation

No irrigation PROCEDURE

A designated unblinded medical team member (nurse, emergency room physician or resident/trainee uninvolved in that particular patient's care) will prepare the laceration for repair. The laceration will not directly be irrigated. In order to ensure blinding of the subjects, the surrounding of the wound will be irrigated with a total of 60 millilitre of normal saline delivered through a 20 Gauge 1 inch long catheter mounted on a 60 millilitre syringe. Care will be taken not to enter a margin of 5cm from the laceration edges. Once completed, the treating physician will enter the room and proceed to the laceration closure with the method and equipment of his choice. Both the patient (through eye covering) and the treating physician will remain blinded to the intervention.

No Irrigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 or older
• repair within 18 hours from time of injury
• repair done by the emergency room physician or trainee
• clean and simple lacerations (clean edge with no gross contamination, as assessed by the treating physician)

You may not qualify if:

• pregnant patients
• involving tendons, muscles, fascias, articulations
• located on the ear, nose or distal to metacarpophalangeal or metatarsophalangeal joint
• immunosuppressed (neutropenia, chronic corticotherapy, HIV, immunosuppressive therapy within 3 months)
• bite wounds
• lacerations with any loss of substance
• lacerations with foreign body
• complex lacerations (crush, stellate)
• grossly contaminated

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Agence de la Sante et des Services Sociaux du Saguenay-Lac-Saint-Jean: collaborator

Study Sites (1)

CIUSSS Saguenay-Lac-St-Jean, Hôpital de Chicoutimi

Chicoutimi, Quebec, G7H5H6, Canada

RECRUITING

Related Publications (18)

• Dire DJ, Welsh AP. A comparison of wound irrigation solutions used in the emergency department. Ann Emerg Med. 1990 Jun;19(6):704-8. doi: 10.1016/s0196-0644(05)82484-9.

  PMID: 2344089 BACKGROUND

• Moscati R, Mayrose J, Fincher L, Jehle D. Comparison of normal saline with tap water for wound irrigation. Am J Emerg Med. 1998 Jul;16(4):379-81. doi: 10.1016/s0735-6757(98)90133-4.

  PMID: 9672456 BACKGROUND

• Moscati RM, Mayrose J, Reardon RF, Janicke DM, Jehle DV. A multicenter comparison of tap water versus sterile saline for wound irrigation. Acad Emerg Med. 2007 May;14(5):404-9. doi: 10.1197/j.aem.2007.01.007.

  PMID: 17456554 BACKGROUND

• Griffiths RD, Fernandez RS, Ussia CA. Is tap water a safe alternative to normal saline for wound irrigation in the community setting? J Wound Care. 2001 Nov;10(10):407-11. doi: 10.12968/jowc.2001.10.10.26149.

  PMID: 12964289 BACKGROUND

• Bansal BC, Wiebe RA, Perkins SD, Abramo TJ. Tap water for irrigation of lacerations. Am J Emerg Med. 2002 Sep;20(5):469-72. doi: 10.1053/ajem.2002.35501.

  PMID: 12216046 BACKGROUND

• Valente JH, Forti RJ, Freundlich LF, Zandieh SO, Crain EF. Wound irrigation in children: saline solution or tap water? Ann Emerg Med. 2003 May;41(5):609-16. doi: 10.1067/mem.2003.137.

  PMID: 12712026 BACKGROUND

• Fernandez R, Griffiths R. Water for wound cleansing. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD003861. doi: 10.1002/14651858.CD003861.pub3.

  PMID: 22336796 BACKGROUND

• Stevenson TR, Thacker JG, Rodeheaver GT, Bacchetta C, Edgerton MT, Edlich RF. Cleansing the traumatic wound by high pressure syringe irrigation. JACEP. 1976 Jan;5(1):17-21. doi: 10.1016/s0361-1124(76)80160-8.

  PMID: 933383 BACKGROUND

• Hollander JE, Richman PB, Werblud M, Miller T, Huggler J, Singer AJ. Irrigation in facial and scalp lacerations: does it alter outcome? Ann Emerg Med. 1998 Jan;31(1):73-7. doi: 10.1016/s0196-0644(98)70284-7.

  PMID: 9437345 BACKGROUND

• Hollander JE, Singer AJ, Valentine S. Comparison of wound care practices in pediatric and adult lacerations repaired in the emergency department. Pediatr Emerg Care. 1998 Feb;14(1):15-8. doi: 10.1097/00006565-199802000-00004.

  PMID: 9516624 BACKGROUND

• Maharaj D, Sharma D, Ramdass M, Naraynsingh V. Closure of traumatic wounds without cleaning and suturing. Postgrad Med J. 2002 May;78(919):281-2. doi: 10.1136/pmj.78.919.281.

  PMID: 12151570 BACKGROUND

• Webster DJ, Davis PW. Closure of abdominal wounds by adhesive strips: a clinical trial. Br Med J. 1975 Sep 20;3(5985):696-8. doi: 10.1136/bmj.3.5985.696.

  PMID: 1100188 BACKGROUND

• Rodeheaver GT, Pettry D, Thacker JG, Edgerton MT, Edlich RF. Wound cleansing by high pressure irrigation. Surg Gynecol Obstet. 1975 Sep;141(3):357-62.

  PMID: 808870 BACKGROUND

• Longmire AW, Broom LA, Burch J. Wound infection following high-pressure syringe and needle irrigation. Am J Emerg Med. 1987 Mar;5(2):179-81. doi: 10.1016/0735-6757(87)90121-5. No abstract available.

  PMID: 3828025 BACKGROUND

• Pronchik D, Barber C, Rittenhouse S. Low- versus high-pressure irrigation techniques in Staphylococcus aureus-inoculated wounds. Am J Emerg Med. 1999 Mar;17(2):121-4. doi: 10.1016/s0735-6757(99)90041-4.

  PMID: 10102307 BACKGROUND

• Singer AJ, Hollander JE, Quinn JV. Evaluation and management of traumatic lacerations. N Engl J Med. 1997 Oct 16;337(16):1142-8. doi: 10.1056/NEJM199710163371607. No abstract available.

  PMID: 9329936 BACKGROUND

• Hollander JE, Singer AJ. Laceration management. Ann Emerg Med. 1999 Sep;34(3):356-67. doi: 10.1016/s0196-0644(99)70131-9.

  PMID: 10459093 BACKGROUND

• Nicks BA, Ayello EA, Woo K, Nitzki-George D, Sibbald RG. Acute wound management: revisiting the approach to assessment, irrigation, and closure considerations. Int J Emerg Med. 2010 Aug 27;3(4):399-407. doi: 10.1007/s12245-010-0217-5.

  PMID: 21373312 BACKGROUND

MeSH Terms

Conditions

Lacerations; Infections

Interventions

Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques

Study Officials

• Julien Bouchard, MD, CCFP(EM)

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julien Bouchard, MD, CCFP(EM)

CONTACT

418-541-1000; julien.bouchard@usherbrooke.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, CCFP(EM)

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 29, 2016
• Study Start: January 1, 2017
• Primary Completion: February 1, 2025
• Study Completion: February 22, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CA (1)