Water for Reducing Pain in Negative Pressure Wound Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-09-30

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.

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Detailed Description

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Conditions

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Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

NPWT with cold water

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

NPWT with normal saline room temp

Intervention Type 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 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.

Group Type PLACEBO_COMPARATOR

NPWT without other intervention

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

NPWT without other intervention

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

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No