Colon CancerNCT01656044
Negative Pressure Therapy in Preventing Infection After Surgery in Patients With Colon, Rectal, Pancreatic, or Peritoneal Surface Cancer
A study testing wound care management in people with Colon Cancer and Pancreatic Cancer, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate if a negative-pressure dressing placed over a surgical incision can reduce the risk of developing a surgical site infection compared to a commonly-used sterile gauze incision dressing. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Pancreatic Cancer, Perioperative/Postoperative Complications
- What is being tested?
- wound care management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Oct 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgical resection for a colorectal, pancreatic, or peritoneal surface malignancy
- The scheduled procedure will be performed via midline laparotomy
- The planned procedure is a clean-contaminated (class II) case (includes gastric, small bowel, and colorectal resections, as well as bile or pancreatic duct transections)
- Ability to understand and the willingness to sign a written informed consent document (either directly or via a legally authorized representative)
Who cannot join
- Emergent cases will not be included in the study
- Pregnant patients will not be included in the study as pregnancy is a relative contraindication for these types of surgical procedures
- Clean (class I), contaminated (class III) and dirty (class IV) procedures will likewise be excluded
- Patients on chronic immunosuppressive medications, including steroids, within the past three months
- Patients with a history of skin allergy to iodine or adhesive drapes
- The planned procedure involves foreign material (such as mesh or subcutaneous drains) being left in the subcutaneous space at the time of surgery (for example, a ventral hernia repair); surgical drains that are placed to drain an intraabdominal space and exit the abdominal wall remote from the incision are allowed in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, 27157
About this study
Official title: The Effect of Negative Pressure Therapy on Incisional Surgical Site Infections
The purpose of this research study is to evaluate if a negative-pressure dressing placed over a surgical incision can reduce the risk of developing a surgical site infection compared to a commonly-used sterile gauze incision dressing. In this study, the negative-pressure dressing will be compared to a standard post-surgical sterile gauze dressing. In this study patients will either receive a negative-pressure dressing or a standard sterile gauze dressing
Read the detailed description
PRIMARY OBJECTIVES:
- To determine whether negative pressure therapy applied to closed laparotomy incisions can decrease the incidence of incisional surgical site infections in patients undergoing clean-contaminated resections for colorectal, pancreatic, and peritoneal surface malignancies compared to standard post-operative sterile gauze dressings.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive standard sterile dressing (SSD) over their closed laparotomy incision at the conclusion of their surgery.
ARM II: Patients receive negative pressure therapy (NPT) dressing over their closed laparotomy incision at the conclusion of their surgery.
After completion of study treatment, patients are followed up at 30 days.
- Conditions
- Colon Cancer, Pancreatic Cancer, Perioperative/Postoperative Complications, Primary Peritoneal Cavity Cancer, Rectal Cancer
- Being tested
- wound care management
- Medical subject headings
- Colonic Neoplasms, Pancreatic Neoplasms, Postoperative Complications, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wound care managementProcedure or surgery
Receive SSD
wound care managementProcedure or surgery
Receive NPT
| Study group | Role | What they receive |
|---|---|---|
| Arm I (SSD) | Active comparator | Patients receive SSD over their closed laparotomy incision at the conclusion of their surgery. Receives: Procedure: wound care management |
| Arm II (NPT) | Experimental | Patients receive NPT dressing over their closed laparotomy incision at the conclusion of their surgery. Receives: Procedure: wound care management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of incisional surgical site infection (SSI), which includes superficial incisional SSIs and deep incisional SSIs as defined by the Center of Disease Control and Prevention
Results will be analyzed initially using descriptive statistics. The proportion of SSI in the NPT group will be compared to the standard post-operative dressing group using a chi square test of proportions.
Measured: 30 days
Secondary outcomes (2)
Rates of organ/space SSIs, seromas, hematomas, incisional cellulitis, and wound opening for any reason
Measured: 30 days
The cost of NPT and SSD, as well as estimate additional costs associated with incisional SSIs in affected patients
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Perry Shen, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656044
- Sponsor's protocol ID
- IRB00020105
- Other IDs
- NCI-2012-00624, CCCWFU 99212
- Status last verified
- Jul 2018
- First submitted
- 31 Jul 2012
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Negative Pressure Therapy on Incisional Surgical Site Infections
- ClinicalTrials.gov ID
- NCT01656044
- Acronym / sponsor ID
- IRB00020105
- Conditions
- Colon Cancer, Pancreatic Cancer, Perioperative/Postoperative Complications, Primary Peritoneal Cavity Cancer, Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 375 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2012
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 2 Aug 2012 (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 research study is to evaluate if a negative-pressure dressing placed over a surgical incision can reduce the risk of developing a surgical site infection compared to a commonly-used sterile gauze incision dressing. In this study, the negative-pressure dressing will be compared to a standard post-surgical sterile gauze dressing. In this study patients will either receive a negative-pressure dressing or a standard sterile gauze dressing
Detailed description
PRIMARY OBJECTIVES:
- To determine whether negative pressure therapy applied to closed laparotomy incisions can decrease the incidence of incisional surgical site infections in patients undergoing clean-contaminated resections for colorectal, pancreatic, and peritoneal surface malignancies compared to standard post-operative sterile gauze dressings.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive standard sterile dressing (SSD) over their closed laparotomy incision at the conclusion of their surgery.
ARM II: Patients receive negative pressure therapy (NPT) dressing over their closed laparotomy incision at the conclusion of their surgery.
After completion of study treatment, patients are followed up at 30 days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (SSD) | Active comparator | Procedure: wound care managementPatients receive SSD over their closed laparotomy incision at the conclusion of their surgery. |
| Arm II (NPT) | Experimental | Procedure: wound care managementPatients receive NPT dressing over their closed laparotomy incision at the conclusion of their surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Surgical resection for a colorectal, pancreatic, or peritoneal surface malignancy
- The scheduled procedure will be performed via midline laparotomy
- The planned procedure is a clean-contaminated (class II) case (includes gastric, small bowel, and colorectal resections, as well as bile or pancreatic duct transections)
- Ability to understand and the willingness to sign a written informed consent document (either directly or via a legally authorized representative)
Key exclusion criteria (6 listed)
- Emergent cases will not be included in the study
- Pregnant patients will not be included in the study as pregnancy is a relative contraindication for these types of surgical procedures
- Clean (class I), contaminated (class III) and dirty (class IV) procedures will likewise be excluded
- Patients on chronic immunosuppressive medications, including steroids, within the past three months
- Patients with a history of skin allergy to iodine or adhesive drapes
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 managementReceive SSD | Procedure or surgery | Arm I (SSD) |
| wound care managementReceive NPT | Procedure or surgery | Arm II (NPT) |
Primary outcome
Rate of incisional surgical site infection (SSI), which includes superficial incisional SSIs and deep incisional SSIs as defined by the Center of Disease Control and Prevention
Time frame: 30 days
Results will be analyzed initially using descriptive statistics. The proportion of SSI in the NPT group will be compared to the standard post-operative dressing group using a chi square test of proportions.
2 secondary outcomes
Rates of organ/space SSIs, seromas, hematomas, incisional cellulitis, and wound opening for any reason
Time frame: 30 days
The cost of NPT and SSD, as well as estimate additional costs associated with incisional SSIs in affected patients
Time frame: 30 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 3 Jul 2018.
Related trials for Colon Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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.
Perry Shen principal investigator
Wake Forest University Health Sciences
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 management in people with Colon Cancer and Pancreatic Cancer, run by Wake Forest University Health Sciences 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 4 inclusion and 6 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 3 Jul 2018. 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 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?
Rate of incisional surgical site infection (SSI), which includes superficial incisional SSIs and deep incisional SSIs as defined by the Center of Disease Control and Prevention (time frame: 30 days). 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 3 Jul 2018.