Water for Reducing Pain in Negative Pressure Wound Therapy

Treatment Clinical Trial

Official title:

Cold Water for Reducing Pain in Negative Pressure Wound Therapy Dressing Change

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02820272
• Other study ID #: 344/55
• Status: Completed
• Phase: Phase 2
• First received: June 24, 2016
• Last updated: June 30, 2016
• Start date: October 2012
• Est. completion date: September 2013

Study information

• Verified date: June 2016
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Treatment

Intervention

Procedure:
• NPWT with cold water
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 normal saline room temp
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 without other intervention
Each of dressing change would be treated with NPWT without injection of any liquids into sponge before dressing change

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain reduction during dressing changes assessed by Visual Analogue Scale (VAS)		3 days	No