TreatmentPhase 2NCT02820272
Water for Reducing Pain in Negative Pressure Wound Therapy
A Phase 2 study testing NPWT with cold water, NPWT with normal saline room temp and NPWT without other intervention in people with Treatment, run by Chulalongkorn University.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Treatment
- What is being tested?
- NPWT with cold water, NPWT with normal saline room temp and NPWT without other intervention
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Oct 2012to Sep 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Open wounded patient who is treated by negative pressure wound therapy (NPWT) with the age between 18-70 years old.
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Treatment
- Being tested
- NPWT with cold water, NPWT with normal saline room temp, NPWT without other intervention
- Keywords
- Cold water, Negative pressure wound therapy, pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NPWT with cold waterProcedure or surgery
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 tempProcedure or surgery
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 interventionProcedure or surgery
Each of dressing change would be treated with NPWT without injection of any liquids into sponge before dressing change
| Study group | Role | What they receive |
|---|---|---|
| NPWT with cold water | Experimental | 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. Receives: Procedure: NPWT with cold water |
| NPWT with normal saline room temp | Active comparator | 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. Receives: Procedure: NPWT with normal saline room temp |
| NPWT without other intervention | Placebo comparator | 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. Receives: Procedure: NPWT without other intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction during dressing changes assessed by Visual Analogue Scale (VAS)
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startOct 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TreatmentStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Apichai Angspatt, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820272
- Sponsor's protocol ID
- 344/55
- Status last verified
- Jun 2016
- First submitted
- 24 Jun 2016
- Last updated
- 1 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Fernandez R, Green HL, Griffiths R, Atkinson RA, Ellwood LJ. Water for wound cleansing. Cochrane Database Syst Rev. 2022 Sep 14;9(9):CD003861. doi: 10.1002/14651858.CD003861.pub4.
PubMed 36103365
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cold Water for Reducing Pain in Negative Pressure Wound Therapy Dressing Change
- ClinicalTrials.gov ID
- NCT02820272
- Acronym / sponsor ID
- 344/55
- Conditions
- Treatment
- Keywords
- Cold water, Negative pressure wound therapy, pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NPWT with cold water | Experimental | Procedure: NPWT with cold waterEach 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. |
| NPWT with normal saline room temp | Active comparator | Procedure: NPWT with normal saline room tempEach 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. |
| NPWT without other intervention | Placebo comparator | Procedure: NPWT without other interventionEach 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Open wounded patient who is treated by negative pressure wound therapy (NPWT) with the age between 18-70 years old.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NPWT with cold waterEach 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 | Procedure or surgery | NPWT with cold water |
| NPWT with normal saline room tempEach 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 | Procedure or surgery | NPWT with normal saline room temp |
| NPWT without other interventionEach of dressing change would be treated with NPWT without injection of any liquids into sponge before dressing change | Procedure or surgery | NPWT without other intervention |
Primary outcome
Pain reduction during dressing changes assessed by Visual Analogue Scale (VAS)
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2016.
- Derived from this study: PubMed 36103365Fernandez R, Green HL, Griffiths R, Atkinson RA, Ellwood LJ. Water for wound cleansing. Cochrane Database Syst Rev. 2022 Sep 14;9(9):CD003861. doi: 10.1002/14651858.CD003861.pub4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NPWT with cold water, NPWT with normal saline room temp and NPWT without other intervention in people with Treatment, run by Chulalongkorn University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain reduction during dressing changes assessed by Visual Analogue Scale (VAS) (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02820272, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2016.