Water for Reducing Pain in Negative Pressure Wound Therapy

Chulalongkorn University

Status and phase: Completed; Phase 2

Conditions: Treatment

Treatments: Procedure: NPWT without other intervention; Procedure: NPWT with cold water; Procedure: NPWT with normal saline room temp

Study type: Interventional

Funder types: Other

Identifiers

NCT02820272

344/55

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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27 participants in 3 patient groups, including a placebo group

NPWT with cold water

Experimental group

Description:

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.

Treatment:

Procedure: NPWT with cold water

NPWT with normal saline room temp

Active Comparator group

Description:

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.

Treatment:

Procedure: NPWT with normal saline room temp

NPWT without other intervention

Placebo Comparator group

Description:

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.

Treatment:

Procedure: NPWT without other intervention