Acute Wounds From TraumaNCT00724750
Comparison of Two Methods of Negative Pressure Wound Therapy
A study testing Gauze suction (G-SUC) and Vacuum Assisted Closure Device (VAC) in people with Acute Wounds From Trauma and Dehiscence or Surgical Complications, run by University of Chicago at 1 site in United States.
Trial summary
The current standard for negative pressure wound therapy is the Vacuum Assisted Closure Device (VAC), a commercial system that utilizes a computerized suction pump to apply negative pressure to an open-cell poly-urethane foam dressing sealed over a wound. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Wounds From Trauma, Dehiscence or Surgical Complications
- What is being tested?
- Gauze suction (G-SUC) and Vacuum Assisted Closure Device (VAC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to May 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized patients at the University of Chicago Medical Center with acute wounds resulting from ether trauma, dehiscence or surgical complications
Who cannot join
- Patients with systemic sepsis caused by wound infection
- Those with grossly necrotic wounds
- Malignancy in the wound
- Wounds with untreated osteomyelitis
- Patients with allergy to sulfamylon and Dakin's (sodium hypochlorite) Patients with 2 first criteria would become eligible once their sepsis resolves and/or necrotic tissue has been debrided from the wound.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
Official title: Prospective Randomized Control Trial Comparing Two Methods of Negative Pressure Wound Therapy: Gauze Suction Versus Vacuum Assisted Closure Device
The current standard for negative pressure wound therapy is the Vacuum Assisted Closure Device (VAC), a commercial system that utilizes a computerized suction pump to apply negative pressure to an open-cell poly-urethane foam dressing sealed over a wound. The VAC system is effective but has some drawbacks:
- The system is expensive.
- There us conflicting data about the effectiveness of VAC therapy for infected wounds.
- VAC therapy is difficult to use (and frequently fails) in wounds with excess fluid drainage, and in wounds near body orifices.
Read more
Over the past 4 years, we have accumulated additional experience with negative pressure wound therapy using wall suction applied to sealed gauze dressings with about 30 patients. We call this method G-SUC and have used it when we have been unable to maintain a dressing seal with the VAC system (due to excess drainage or wound location), for management if infected wounds. We have found this method to be effective without any specific negative side effects.
Our specific aims are:
- Compare the effectiveness of G-SUC and standard VAC therapy. Outcomes measured for each method will include the proportional change in wound size over 1 - 2 weeks.
- Compare the effectiveness of G-SUC and VAC system in controlling wound infections as measured by the number of patients who are able to clear infection by 4 days.
- Compare the failure of each method of therapy by documenting the number of dressing that cannot be maintained because of fluid or suction.
- Measure and compare the cost of wound treatment with the two methods including direct cost and time spent at the bed side performing the dressing change.
Our hypotheses are:
- G-SUC and VAC are equivalent for the treatment of uncomplicated wounds in the acute care, in-patient setting.
- G-SUC is more effective than VAC for management of infected wounds.
- G-SUC is more versatile than VAC, and functional G-SUC dressings can be maintained in situations where functional VAC dressings cannot.
- Negative pressure therapy with G-SUC is less costly than VAC.
- Being tested
- Gauze suction (G-SUC), Vacuum Assisted Closure Device (VAC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gauze suction (G-SUC)Device
Negative pressure wound therapy
Vacuum Assisted Closure Device (VAC)Device
Negative Pressure Wound Therapy
| Study group | Role | What they receive |
|---|---|---|
| G-SUC | Experimental | Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily. Receives: Device: Gauze suction (G-SUC) |
| Vacuum Assisted Closure | Active comparator | Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours. Receives: Device: Vacuum Assisted Closure Device (VAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change Per Day in Wound Surface Area
Wound surface area was measured daily. The percent change from Day 1 was calculated. A negative value indicates a decrease.
Measured: 7 days
Percent Change Per Day in Wound Volume
Wound volume was measured daily. The percent change from Day 1 was calculated. A negative value indicates a decrease.
Measured: 7 days
Secondary outcomes (4)
Failure to Maintain Dressing Because of Fluid or Suction Leaks
Measured: Participants were followed for the duration of inpatient stay, an average of 5 days.
Average Time Spent on Dressing Changes
Time was measured from the start of the dressing change until the initiation of suction.
Measured: Participants were followed for the duration of inpatient stay, an average of 5 days.
Pain Score With Dressing Changes
Self-reported pain levels were used to assess pain. Patients were asked to rate their pain level according to the 0 to 10 linear analog scale immediately before, during, and after removal of the dressing. The average number of dressing changes for the G-SUC group was 4.5 (range 2-15) and the average number of dressing changes for the VAC group was 2.8 (range 2-6). The sum of pain intensity differences (SPID) was used to facilitate comparison of pain levels. The SPID score was calculated for each dressing change using the formula: (pain during - pain before) + (pain after - pain during). Higher values indicating greater pain.
Measured: Participants were followed for the duration of inpatient stay, an average of 5 days.
Average Cost of Supplies and Rental
Direct costs for each type of dressing were measured. In the VAC group, this included rental charges for the equipment and the cost of supplies. In the G-SUC group, this included the cost of supplies (suction canisters, catheters or drains, tubing, gauze, and adhesive drapes).
Measured: Participants were followed for the duration of inpatient stay, an average of 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startJul 2006
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Wounds From TraumaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lawrence J Gottlieb, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724750
- Sponsor's protocol ID
- 14817A
- Status last verified
- Sep 2015
- First submitted
- 25 Jul 2008
- Last updated
- 19 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Dorafshar AH, Franczyk M, Gottlieb LJ, Wroblewski KE, Lohman RF. A prospective randomized trial comparing subatmospheric wound therapy with a sealed gauze dressing and the standard vacuum-assisted closure device. Ann Plast Surg. 2012 Jul;69(1):79-84. doi: 10.1097/SAP.0b013e318221286c.
PubMed 21712704
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Control Trial Comparing Two Methods of Negative Pressure Wound Therapy: Gauze Suction Versus Vacuum Assisted Closure Device
- ClinicalTrials.gov ID
- NCT00724750
- Acronym / sponsor ID
- 14817A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 30 Jul 2008 (estimated)
- Results
- Posted 19 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current standard for negative pressure wound therapy is the Vacuum Assisted Closure Device (VAC), a commercial system that utilizes a computerized suction pump to apply negative pressure to an open-cell poly-urethane foam dressing sealed over a wound. The VAC system is effective but has some drawbacks:
- The system is expensive.
- There us conflicting data about the effectiveness of VAC therapy for infected wounds.
- VAC therapy is difficult to use (and frequently fails) in wounds with excess fluid drainage, and in wounds near body orifices.
Over the past 4 years, we have accumulated additional experience with negative pressure wound therapy using wall suction applied to sealed gauze dressings with about 30 patients. We call this method G-SUC and have used it when we have been unable to maintain a dressing seal with the VAC system (due to excess drainage or wound location), for management if infected wounds. We have found this method to be effective without any specific negative side effects.
Our specific aims are:
- Compare the effectiveness of G-SUC and standard VAC therapy. Outcomes measured for each method will include the proportional change in wound size over 1 - 2 weeks.
- Compare the effectiveness of G-SUC and VAC system in controlling wound infections as measured by the number of patients who are able to clear infection by 4 days.
- Compare the failure of each method of therapy by documenting the number of dressing that cannot be maintained because of fluid or suction.
- Measure and compare the cost of wound treatment with the two methods including direct cost and time spent at the bed side performing the dressing change.
Our hypotheses are:
- G-SUC and VAC are equivalent for the treatment of uncomplicated wounds in the acute care, in-patient setting.
- G-SUC is more effective than VAC for management of infected wounds.
- G-SUC is more versatile than VAC, and functional G-SUC dressings can be maintained in situations where functional VAC dressings cannot.
- Negative pressure therapy with G-SUC is less costly than VAC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G-SUC | Experimental | Device: Gauze suction (G-SUC)Gauze suction (G-SUC) Negative Pressure Wound Therapy, continuous wall suction at 75 to 80 mm Hg was applied and dressings were changed daily. |
| Vacuum Assisted Closure | Active comparator | Device: Vacuum Assisted Closure Device (VAC)Vacuum Assisted Closure Device (VAC) Negative Pressure Wound Therapy, continuous suction at 75 to 125 mm Hg and the dressing was changed every 48 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Hospitalized patients at the University of Chicago Medical Center with acute wounds resulting from ether trauma, dehiscence or surgical complications
Key exclusion criteria (5 listed)
- Patients with systemic sepsis caused by wound infection
- Those with grossly necrotic wounds
- Malignancy in the wound
- Wounds with untreated osteomyelitis
- Patients with allergy to sulfamylon and Dakin's (sodium hypochlorite) Patients with 2 first criteria would become eligible once their sepsis resolves and/or necrotic tissue has been debrided from the wound.
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 |
|---|---|---|
| Gauze suction (G-SUC)Negative pressure wound therapy | Device | G-SUC |
| Vacuum Assisted Closure Device (VAC)Negative Pressure Wound Therapy | Device | Vacuum Assisted Closure |
Primary outcome
Percent Change Per Day in Wound Surface Area
Time frame: 7 days
Wound surface area was measured daily. The percent change from Day 1 was calculated. A negative value indicates a decrease.
Percent Change Per Day in Wound Volume
Time frame: 7 days
Wound volume was measured daily. The percent change from Day 1 was calculated. A negative value indicates a decrease.
4 secondary outcomes
Failure to Maintain Dressing Because of Fluid or Suction Leaks
Time frame: Participants were followed for the duration of inpatient stay, an average of 5 days.
Average Time Spent on Dressing Changes
Time frame: Participants were followed for the duration of inpatient stay, an average of 5 days.
Pain Score With Dressing Changes
Time frame: Participants were followed for the duration of inpatient stay, an average of 5 days.
Average Cost of Supplies and Rental
Time frame: Participants were followed for the duration of inpatient stay, an average of 5 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21712704Dorafshar AH, Franczyk M, Gottlieb LJ, Wroblewski KE, Lohman RF. A prospective randomized trial comparing subatmospheric wound therapy with a sealed gauze dressing and the standard vacuum-assisted closure device. Ann Plast Surg. 2012 Jul;69(1):79-84. doi: 10.1097/SAP.0b013e318221286c.
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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.
Lawrence J Gottlieb, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gauze suction (G-SUC) and Vacuum Assisted Closure Device (VAC) in people with Acute Wounds From Trauma and Dehiscence or Surgical Complications, run by University of Chicago 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 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 19 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?
Yes. Results are posted in the registry (first posted 19 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change Per Day in Wound Surface Area (time frame: 7 days). The study lists 2 primary outcomes in all. 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 NCT00724750, 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 19 Oct 2015.