Patients Undergoing Hepatopancreatobiliary SurgeryNCT01905397
Negative Pressure Wound Therapy to Reduce Surgical Site Infection
A study testing Conventional wound therapy and Negative pressure wound therapy in people with Patients Undergoing Hepatopancreatobiliary Surgery, run by Duke University at 2 sites in United States.
Trial summary
The purpose of this study is to compare the rate of surgical site infection between traditional wound care and negative pressure wound therapy. Wounds will be assessed 4-5 days after surgery and at the first clinic visit after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Undergoing Hepatopancreatobiliary Surgery
- What is being tested?
- Conventional wound therapy and Negative pressure wound therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Dec 2013to 26 May 2021
- 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
- Female and male patients 18 years of age or older
- Scheduled for an elective surgery in either open CRS or open HPBS. This includes, but is not limited to: ileocecectomy, right hemicolectomy, extended right hemicolectomy, transverse colectomy, left hemicolectomy, sigmoidectomy, proctectomy, low anterior resection, or abdominoperineal resection gastrectomy, hepatectomy, bile duct reconstruction, duodenectomy, pancreatectomy, pancreaticoduodenectomy, or pancreatic duct reconstruction
Who cannot join
- The need for emergency surgery.
- The need for use of only laparoscopic surgery.
- Presence of bowel obstruction, strangulation, peritonitis or perforation.
- The presence of local or systemic infection preoperatively.
- ASA class ≥4.
- Inability to provide informed consent and authorization.
- Known allergy or hypersensitivity to silver.
- Any clinically significant condition that, in the investigator's opinion, would significantly impair the subject's ability to comply with the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27710
Indiana University
Indianapolis, Indiana, 46223
About this study
Official title: Evaluation of Negative Pressure Wound Therapy for Reduction of Postoperative Surgical Site Infection in Patients Undergoing Colorectal and Hepatopancreatobiliary Surgery
The purpose of this study is to compare the rate of surgical site infection between traditional wound care and negative pressure wound therapy. Wounds will be assessed 4-5 days after surgery and at the first clinic visit after surgery.
- Being tested
- Conventional wound therapy, Negative pressure wound therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional wound therapyDevice
Sterile bandages and wound coverings
Negative pressure wound therapyDevice
Also called Prevena Incision Management System; ActiVAC
The Prevena Incision Management System covers and protects the incision from external infectious sources, while negative pressure removes fluid and infectious material from the surgical incision. The ActiVAC pump may be used with the Prevena dressings as well in some situations to achieve negative pressure.
| Study group | Role | What they receive |
|---|---|---|
| Negative Pressure Wound Therapy | Active comparator | The Prevena Incision Management System is a 510K cleared device that covers and protects the incision from external infectious sources, while negative pressure removes fluid and infectious material from the surgical incision. The ActiVAC pump (also 510K cleared) may be used in some cases with the Prevena dressings as to achieve the negative pressure Receives: Device: Negative pressure wound therapy |
| Conventional wound therapy | Active comparator | Traditional wound therapy (sterile bandages and dressing) Receives: Device: Conventional wound therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With a Surgical Site Infection
Number and percentage of participants with at least 1 surgical site infection (SSI).
Measured: 30 days after surgery; assessed at 4-5 days and 30 days post-operation
Secondary outcomes (2)
Number of Surgical Site Infections by Type
Each surgical site infection was classified into one of the following categories: superficial incisional, deep incisional, or organ/space (as defined by The American College of Surgeons NSQIP [National Surgical Quality Improvement Program] guidelines). The number of infections in each category is reported separately for both treatment arms. Some participants had multiple infections.
Measured: 30 days post-surgery
Length of Hospital Stay
Assess (or compare) the length of hospital stay between subjects who receive standard of care and incisional V.A.C. via PIMS.
Measured: Up to 62 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study start18 Dec 2013
- Primary completion26 May 2021
- Study completion26 May 2021
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 Patients Undergoing Hepatopancreatobiliary SurgeryStudies of the same condition, open and under way.
- More trials run by Duke 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Kinetic Concepts, Inc.
- Responsible party
- Sponsor
- Investigators
- Dan Blazer, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905397
- Sponsor's protocol ID
- Pro00045975
- Status last verified
- Nov 2022
- First submitted
- 18 Jul 2013
- Last updated
- 2 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ceppa EP, Kim RC, Niedzwiecki D, Lowe ME, Warren DA, House MG, Nakeeb A, Zani S, Moyer AN, Blazer DG 3rd; Closed Incision Negative Pressure Therapy (ciNPT) Investigators. Closed Incision Negative Pressure Therapy to Reduce Surgical Site Infection in High-Risk Gastrointestinal Surgery: A Randomized Controlled Trial. J Am Coll Surg. 2023 Apr 1;236(4):698-708. doi: 10.1097/XCS.0000000000000547. Epub 2023 Jan 10.
PubMed 36728375
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Negative Pressure Wound Therapy for Reduction of Postoperative Surgical Site Infection in Patients Undergoing Colorectal and Hepatopancreatobiliary Surgery
- ClinicalTrials.gov ID
- NCT01905397
- Acronym / sponsor ID
- Pro00045975
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Kinetic Concepts, Inc.
- Study start
- 18 Dec 2013 (actual)
- Primary completion
- 26 May 2021 (actual)
- Study completion
- 26 May 2021 (actual)
- First posted
- 23 Jul 2013 (estimated)
- Results
- Posted 10 Oct 2022
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 compare the rate of surgical site infection between traditional wound care and negative pressure wound therapy. Wounds will be assessed 4-5 days after surgery and at the first clinic visit after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative Pressure Wound Therapy | Active comparator | Device: Negative pressure wound therapyThe Prevena Incision Management System is a 510K cleared device that covers and protects the incision from external infectious sources, while negative pressure removes fluid and infectious material from the surgical incision. The ActiVAC pump (also 510K cleared) may be used in some cases with the Prevena dressings as to achieve the negative pressure |
| Conventional wound therapy | Active comparator | Device: Conventional wound therapyTraditional wound therapy (sterile bandages and dressing) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Female and male patients 18 years of age or older
- Scheduled for an elective surgery in either open CRS or open HPBS. This includes, but is not limited to: ileocecectomy, right hemicolectomy, extended right hemicolectomy, transverse colectomy, left hemicolectomy, sigmoidectomy, proctectomy, low anterior resection, or abdominoperineal resection gastrectomy, hepatectomy, bile duct reconstruction, duodenectomy, pancreatectomy, pancreaticoduodenectomy, or pancreatic duct reconstruction
Key exclusion criteria (8 listed)
- The need for emergency surgery.
- The need for use of only laparoscopic surgery.
- Presence of bowel obstruction, strangulation, peritonitis or perforation.
- The presence of local or systemic infection preoperatively.
- ASA class ≥4.
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 |
|---|---|---|
| Conventional wound therapySterile bandages and wound coverings | Device | Conventional wound therapy |
| Negative pressure wound therapyAlso: Prevena Incision Management System; ActiVACThe Prevena Incision Management System covers and protects the incision from external infectious sources, while negative pressure removes fluid and infectious material from the surgical incision. The ActiVAC pump may be used with the Prevena dressings as well in some situations to achieve negative pressure. | Device | Negative Pressure Wound Therapy |
Primary outcome
Participants With a Surgical Site Infection
Time frame: 30 days after surgery; assessed at 4-5 days and 30 days post-operation
Number and percentage of participants with at least 1 surgical site infection (SSI).
2 secondary outcomes
Number of Surgical Site Infections by Type
Time frame: 30 days post-surgery
Length of Hospital Stay
Time frame: Up to 62 days post-surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36728375Ceppa EP, Kim RC, Niedzwiecki D, Lowe ME, Warren DA, House MG, Nakeeb A, Zani S, Moyer AN, Blazer DG 3rd; Closed Incision Negative Pressure Therapy (ciNPT) Investigators. Closed Incision Negative Pressure Therapy to Reduce Surgical Site Infection in High-Risk Gastrointestinal Surgery: A Randomized Controlled Trial. J Am Coll Surg. 2023 Apr 1;236(4):698-708. doi: 10.1097/XCS.0000000000000547. Epub 2023 Jan 10.
- Individual participant dataSharing planned: No
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.
Dan Blazer, MD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional wound therapy and Negative pressure wound therapy in people with Patients Undergoing Hepatopancreatobiliary Surgery, run by Duke University at 2 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 2 inclusion and 8 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 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 10 Oct 2022). 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?
Participants With a Surgical Site Infection (time frame: 30 days after surgery; assessed at 4-5 days and 30 days post-operation). 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 NCT01905397, 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 2 Dec 2022.