Water for Reducing Pain in Negative Pressure Wound Therapy

Study Overview
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Brief Summary
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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.

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

Conditions
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Treatment

Intervention / Treatment
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* Procedure: NPWT with cold water
* Procedure: NPWT with normal saline room temp
* Procedure: NPWT without other intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cold water, Negative pressure wound therapy, pain