Water for Reducing Pain in Negative Pressure Wound Therapy

June 30, 2016 updated by: Apichai Angspatt, Chulalongkorn University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NPWT with cold water
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
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
Active Comparator: NPWT with normal saline room temp
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
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
Placebo Comparator: NPWT without other intervention
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
Each of dressing change would be treated with NPWT without injection of any liquids into sponge before dressing change

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain reduction during dressing changes assessed by Visual Analogue Scale (VAS)
Time Frame: 3 days
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

June 24, 2016

First Submitted That Met QC Criteria

June 29, 2016

First Posted (Estimate)

June 30, 2016

Study Record Updates

Last Update Posted (Estimate)

July 1, 2016

Last Update Submitted That Met QC Criteria

June 30, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 344/55

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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