Water for Reducing Pain in Negative Pressure Wound Therapy

NCT02820272 | Completed Phase 2

• 1 other identifier: 344/55
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

Brief Summary

Negative pressure wound therapy (NPWT) is a technique using vacuum dressing to promote wound healing in complicated wound. However for many patients, the application and removal of the NPWT is source of procedural pain. Some techniques had been reported to reduce these pain such as administering topical lidocain or normal saline solution before the dressing change. The authors hypothesized that administering cold water into the NPWT sponge would decrease pain during dressing changes.

Conditions

Treatment

Keywords

Cold water; Negative pressure wound therapy; pain

Outcome Measures

Primary Outcomes (1)

• Pain reduction during dressing changes assessed by Visual Analogue Scale (VAS)

  3 days

Study Arms (3)

NPWT with cold water

EXPERIMENTAL

Each patient will be randomized for dressing method sequence, and each of them would be treated for total of three times of NPWT dressing changes over study period. This arm was the intervention with injection of cold sterile water kept in 4°C temperature into sponge 10 minutes before dressing change.

Procedure: NPWT with cold water

NPWT with normal saline room temp

ACTIVE COMPARATOR

Each patient will be randomized for dressing method sequence, and each of them would be treated for total of three times of NPWT dressing changes over study period. This arm was the intervention with injection of room temperature sterile water kept in room temperature into sponge 10 minutes before dressing change.

Procedure: NPWT with normal saline room temp

NPWT without other intervention

PLACEBO COMPARATOR

Each patient will be randomized for dressing method sequence, and each of them would be treated for total of three times of NPWT dressing changes over study period. This arm was no injection of any liquids into sponge before dressing change.

Procedure: NPWT without other intervention

Interventions

NPWT with cold water PROCEDURE

Each of dressing change would be treated with NPWT and injection of cold sterile water kept in 4°C temperature into sponge 10 minutes before dressing change

NPWT with cold water

NPWT with normal saline room temp PROCEDURE

Each of dressing change would be treated with NPWT and injection of room temperature sterile water kept in room temperature into sponge 10 minutes before dressing change

NPWT with normal saline room temp

NPWT without other intervention PROCEDURE

Each of dressing change would be treated with NPWT without injection of any liquids into sponge before dressing change

NPWT without other intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Open wounded patient who is treated by negative pressure wound therapy (NPWT) with the age between 18-70 years old.

You may not qualify if:

• The patient who has decrease sensation at cured wound region
• The patient who has Glasgow coma scale less than 15
• The patient who cannot provide pain scale data
• The patient who has diabetic ulcer or other chronic sores
• The patient who denies to participate in research project.

Sponsors & Collaborators

• Chulalongkorn University: lead

Related Publications (1)

• Fernandez R, Green HL, Griffiths R, Atkinson RA, Ellwood LJ. Water for wound cleansing. Cochrane Database Syst Rev. 2022 Sep 14;9(9):CD003861. doi: 10.1002/14651858.CD003861.pub4.

  PMID: 36103365 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2016
• First Posted: June 30, 2016
• Study Start: October 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: July 1, 2016

Record last verified: 2016-06