WoundsNCT00121537
Study to Determine the Utility of Wound Vacuum Assisted Closure (VAC) Compared to Conventional Saline Dressing Changes
A study testing Wound Care -Wound Vacuum Assisted Closure (VAC) and Wound Care - Wet to Dry Dressing Changes in people with Wounds and Compartment Syndromes, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
The purpose of this study is to look at the use of the wound vacuum assisted closure (VAC) versus standard wet to dry dressing in treating lower leg fasciotomies. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Wounds, Compartment Syndromes
- What is being tested?
- Wound Care -Wound Vacuum Assisted Closure (VAC) and Wound Care - Wet to Dry Dressing Changes
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Oct 2006
- Phase
- Interventional
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- four compartment fasciotomies performed on one or both lower extremities
- subject and/or subject's legally authorized representative (next-of-kin) has voluntarily signed and dated informed consent.
Who cannot join
- inability to place wound VAC
- contraindications for wound VAC use
- pregnant females
- prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study to Determine the Utility of Vacuum Assisted Closure (VAC) Compared to Conventional Saline Dressing Changes With Regards to Lower Extremity Fasciotomy Wound Healing, Complications, Cost and Patient and Nursing Satisfaction
The purpose of this study is to look at the use of the wound vacuum assisted closure (VAC) versus standard wet to dry dressing in treating lower leg fasciotomies.
- Conditions
- Wounds, Compartment Syndromes
- Being tested
- Wound Care -Wound Vacuum Assisted Closure (VAC), Wound Care - Wet to Dry Dressing Changes
- Keywords
- wounds-open
- Medical subject headings
- Wounds and Injuries, Compartment Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wound Care -Wound Vacuum Assisted Closure (VAC)Device
Wound Care - Wet to Dry Dressing ChangesProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of wound healing
Secondary outcomes (4)
Time to delayed primary wound closure
Time to completion of secondary healing
Patient satisfaction
Nurse satisfaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2005 (estimated)
- Study startJul 2005
- Study completionOct 2006
Why it stopped: terminated, due to lack enrollment,
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WoundsStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Investigators
- John G Myers, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00121537
- Sponsor's protocol ID
- 045-1502-226
- Status last verified
- Oct 2015
- First submitted
- 13 Jul 2005
- Last updated
- 8 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Determine the Utility of Vacuum Assisted Closure (VAC) Compared to Conventional Saline Dressing Changes With Regards to Lower Extremity Fasciotomy Wound Healing, Complications, Cost and Patient and Nursing Satisfaction
- ClinicalTrials.gov ID
- NCT00121537
- Acronym / sponsor ID
- 045-1502-226
- Conditions
- Wounds, Compartment Syndromes
- Keywords
- wounds-open
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated, due to lack enrollment,
- Enrolment
- 30 participants
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Jul 2005
- Study completion
- Oct 2006 (actual)
- First posted
- 21 Jul 2005 (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.
The purpose of this study is to look at the use of the wound vacuum assisted closure (VAC) versus standard wet to dry dressing in treating lower leg fasciotomies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- four compartment fasciotomies performed on one or both lower extremities
- subject and/or subject's legally authorized representative (next-of-kin) has voluntarily signed and dated informed consent.
Key exclusion criteria (4 listed)
- inability to place wound VAC
- contraindications for wound VAC use
- pregnant females
- prisoners
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 |
|---|---|---|
| Wound Care -Wound Vacuum Assisted Closure (VAC) | Device | – |
| Wound Care - Wet to Dry Dressing Changes | Procedure or surgery | – |
Primary outcome
Rate of wound healing
4 secondary outcomes
Time to delayed primary wound closure
Time to completion of secondary healing
Patient satisfaction
Nurse satisfaction
Results and safety
The study was stopped early (reason given: terminated, due to lack enrollment,). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
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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.
John G Myers, MD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wound Care -Wound Vacuum Assisted Closure (VAC) and Wound Care - Wet to Dry Dressing Changes in people with Wounds and Compartment Syndromes, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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 2 inclusion and 4 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: stopped early, as of the sponsor's last update on 8 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: terminated, due to lack enrollment,). Results are not available in the source record.
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?
Rate of wound healing. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2015.