Wounds and InjuriesNCT01867580

A Pilot RCT of Veraflo With Prontosan vs VAC in Wounds Requiring Operative Debridement

A study testing V.A.C.Ulta with Prontosan instillation and V.A.C.Ulta without instillation in people with Wounds and Injuries, run by KCI USA, Inc at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to examine the effectiveness of the Veraflo with Prontosan vs VAC in wounds that require operative debridement. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Wounds and Injuries
What is being tested?: V.A.C.Ulta with Prontosan instillation and V.A.C.Ulta without instillation
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 181 participants
Where: 7 sitesUnited States
Study dates: May 2013to Nov 2015
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

The Subject:
has a wound prior to informed consent
will be admitted as an inpatient
is >= 18 years of age at time of consent
is able to provide his/her own informed consent
is willing and able to return for all scheduled and required study visits

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has an open wound >= 4cm in any plane of measurement excluding tunnels after initial surgical debridement
has a wound that is appropriate for NPWT according to approved indications for use
has not participated in a clinical trial within the past 30 days
has a 30 day wound history available if the wound has been previously treated

Who cannot join

The Subject:
is pregnant as determined by a positive serum or urine pregnancy test at the time of screening
has a life expectancy of < 12 months
is not healthy enough to undergo surgery for any reason
has, in the investigator's opinion, any clinically significant condition that would impair the participant's ability to comply with the study procedures
has, in the opinion of the investigator, a condition that will not allow the subject to tolerate the therapy (e.g. painful conditions such as vasculitis)

Show all 27Show fewer

has rheumatoid arthritis
has a bleeding disorder or coagulopathy
has a wound that contains antibiotic cement or beads
has an ischemic lower extremity wound as determined by lack of detectable pulses in the extremity or ankle-brachial pressure indices of < 0.9 with a history of diabetes, or < 0.6 if the subject is non-diabetic
has a known allergy or hypersensitivity to V.A.C. Therapy dressing components including polyurethane or polyvinyl alcohol (drape and foam), or materials that contain acrylic adhesive (drape adhesive)
has a known allergy or hyper sensitivity to 3M Cavilon No Sting Barrier Film or any of its components including Hexamethyldisiloxane, isooctane, acrylate terpolymer, polyphenylmethysiloxane, copolymer
has a know allergy or hypersensitivity to Prontosan or any of its components including polyhexamethylene biguanide (PHMB), or undecylenamidopropyl betaine
has received NPWT on the study wound within the last 30 days
has a wound that is contraindicated with Prontosan
presence of hyaline cartilage in the wound
has a wound that is contraindicated with V.A.C. Therapy including:
malignancy in the wound
untreated osteomyelitis
non-enteric or unexplored fistulas
necrotic tissue with eschar remaining in the wound after debridement (NOTE: Once necrotic tissue or eschar is removed from the wound bed, subjects may be included)
unprotected, exposed blood vessels, anastomotic sites, organs, or nerves in direct contact with foam
use of intervening layers between the wound bed and foam
has a wound that is contraindicated with V.A.C. VeraFlo Therapy including:
Thoracic or abdominal cavities
Unexplored wounds that may communicate with adjacent body cavities
has a wound that is closed after the initial debridement

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

St. Luke's University Hospital
Bethlehem, Pennsylvania, 18015
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Northwestern University
Chicago, Illinois, 60611
University of Texas Southwestern
Dallas, Texas, 75390
University of Miami Miller School of Medicine
Miami, Florida, 33136
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: A Prospective, Randomized, Multi-Center Trial Evaluating the Effectiveness of the V.A.C. Ulta Negative Pressure Wound Therapy System With V.A.C. VeraFlo Dressing System in Operatively Debrided Wounds

The purpose of this study is to examine the effectiveness of the Veraflo with Prontosan vs VAC in wounds that require operative debridement.

Conditions: Wounds and Injuries
Being tested: V.A.C.Ulta with Prontosan instillation, V.A.C.Ulta without instillation
Medical subject headings: Wounds and Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

V.A.C.Ulta with Prontosan instillationDevice
NPWT with instillation of a wound cleanser (Prontosan® Wound Irrigation Solution)
V.A.C.Ulta without instillationDevice
NPWT only

Study groups in NCT01867580
Study group	Role	What they receive
V.A.C.Ulta with Prontosan instillation	Experimental	Treatment Arm Receives: Device: V.A.C.Ulta with Prontosan instillation
V.A.C.Ulta without instillation	Active comparator	Control Arm Receives: Device: V.A.C.Ulta without instillation

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Inpatient Operating Room Debridements
Debridement in this outcome refers to surgical removal of non viable tissue performed in an operating room
Measured: until the wound is deemed ready for closure or coverage by the investigator up to 64 days

Secondary outcomes (1)

The Difference in Total Bacterial Counts Measured in Colony Forming Units (CFU) as Determined by Quantitative PCR Analysis.
Measured: Immediately following initial post debridement to the first dressing change up to 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2013Nov 2015

First posted4 Jun 2013 (estimated)
Study startMay 2013
Primary completionAug 2015
Study completionNov 2015

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.
Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
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: 181 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01867580
Sponsor's protocol ID: AHS.2011.ULTA.04
Status last verified: Nov 2024
First submitted: 9 May 2013
Last updated: 2 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Randomized, Multi-Center Trial Evaluating the Effectiveness of the V.A.C. Ulta Negative Pressure Wound Therapy System With V.A.C. VeraFlo Dressing System in Operatively Debrided Wounds
ClinicalTrials.gov ID: NCT01867580
Acronym / sponsor ID: AHS.2011.ULTA.04
Conditions: Wounds and Injuries
Study type: Interventional
Recruitment status: Completed
Enrolment: 181 participants (actual)
Lead sponsor: KCI USA, IncIndustry (pharma, biotech, devices)
Study start: May 2013
Primary completion: Aug 2015 (actual)
Study completion: Nov 2015 (actual)
First posted: 4 Jun 2013 (estimated)
Results: Posted 29 Nov 2017

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 examine the effectiveness of the Veraflo with Prontosan vs VAC in wounds that require operative debridement.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
V.A.C.Ulta with Prontosan instillation	Experimental	Device: V.A.C.Ulta with Prontosan instillationTreatment Arm
V.A.C.Ulta without instillation	Active comparator	Device: V.A.C.Ulta without instillationControl Arm

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

has a wound prior to informed consent
will be admitted as an inpatient
is >= 18 years of age at time of consent
is able to provide his/her own informed consent
is willing and able to return for all scheduled and required study visits

Key exclusion criteria (27 listed)

is pregnant as determined by a positive serum or urine pregnancy test at the time of screening
has a life expectancy of < 12 months
is not healthy enough to undergo surgery for any reason
has, in the investigator's opinion, any clinically significant condition that would impair the participant's ability to comply with the study procedures
has, in the opinion of the investigator, a condition that will not allow the subject to tolerate the therapy (e.g. painful conditions such as vasculitis)

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
V.A.C.Ulta with Prontosan instillationNPWT with instillation of a wound cleanser (Prontosan® Wound Irrigation Solution)	Device	V.A.C.Ulta with Prontosan instillation
V.A.C.Ulta without instillationNPWT only	Device	V.A.C.Ulta without instillation

Primary outcome

Number of Inpatient Operating Room Debridements
Time frame: until the wound is deemed ready for closure or coverage by the investigator up to 64 days
Debridement in this outcome refers to surgical removal of non viable tissue performed in an operating room

1 secondary outcome

The Difference in Total Bacterial Counts Measured in Colony Forming Units (CFU) as Determined by Quantitative PCR Analysis.
Time frame: Immediately following initial post debridement to the first dressing change up to 72 hours

Results and safety

Results posted to the registry on 29 Nov 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
V.A.C.Ulta With Prontosan Instillation	93	65
V.A.C.Ulta Without Instillation	88	64

Primary outcome: Number of Inpatient Operating Room Debridements

Time frame: until the wound is deemed ready for closure or coverage by the investigator up to 64 days. Count of participants. Unit: Participants

Measure	V.A.C.Ulta With Prontosan Instillation n = 71	V.A.C.Ulta Without Instillation n = 66
0 debridements	9	13
1 debridement	52	41
2 debridements	5	10
3 debridements	3	2
4 debridements	2	0

V.A.C.Ulta With Prontosan Instillation vs V.A.C.Ulta Without Instillation: p = 0.6770, Regression, Logistic

Population analysed: Per-protocol population

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
V.A.C.Ulta With Prontosan Instillation	19 of 93 (20.4%)	58 of 93 (62.4%)	3 of 93
V.A.C.Ulta Without Instillation	22 of 88 (25%)	44 of 88 (50%)	1 of 88

Limitations and caveats (from the sponsor): Prontosan was used for instillation in this study. Approximately \~75% of wounds were not infected. Therefore benefits from a solution with antiseptic properties would be expected to be limited. Acelity is planning to conduct a study using saline.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing V.A.C.Ulta with Prontosan instillation and V.A.C.Ulta without instillation in people with Wounds and Injuries, run by KCI USA, Inc at 7 sites 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 10 inclusion and 27 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 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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 29 Nov 2017). 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?

Number of Inpatient Operating Room Debridements (time frame: until the wound is deemed ready for closure or coverage by the investigator up to 64 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 NCT01867580.

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 2 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.