Wounds and InjuriesNCT02883010
Comparison of Surgical Incision Complications in Patients Receiving PICO or Standard Care Following Colorectal Surgery
A study testing PICO Softport V1.6 in people with Wounds and Injuries, run by Smith & Nephew, Inc..
Trial summary
Surgical Site Complications (SSC's) are responsible for increased morbidity in patients undergoing surgery resulting in prolonged length of stay in the hospital while increasing treatment and hospital costs dramatically. 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?
- PICO Softport V1.6
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jan 2017
- 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
- The subject or legal guardian must provide written informed consent (reference section 9.1).
- Subjects eighteen (18) years of age or older.
- Willing and able to make all required study visits.
- Able to follow instructions.
- Males or females.
- Subject must be classified as a high risk patient in terms of likelihood for SSC's (i.e., heavy smoker (more than 20 cigarettes per day), diabetic, BMI ≥ 30, immunocompromised) or be treated as an emergency patient with obstructed bowel, perforated bowel or peritonitis and be undergoing any of the following procedures:- Left hemicolectomy, right hemicolectomy, extended right hemicolectomy, sigmoidectomy, anterior rectum resection, total colectomy.
Who cannot join
- Contraindications or hypersensitivity to the use of the investigational product or its components (e.g., silicone adhesives and polyurethane films [direct contact with incision], acrylic adhesives [direct contact with skin], polyethylene fabrics and super-absorbent powders [polyacrylates]) within the dressing.
- Subjects with extremely fragile skin who require the use of SECURA non-sting barrier skin wipes and have hypersensitivity to the ingredients in the wipes.
- Participation in another clinical trial (with use of investigational medicinal product or medical device) within thirty (30) days of Visit 1 or during the study.
- Subjects with skin features (e.g., tattoos, pre-existing scarring) which, in the opinion of the Investigator, could interfere with the study assessments.
- Subjects who have participated previously in this clinical trial.
- Subjects with a reference incision (that is the largest incision that is made during the surgery and the one that is allocated to study treatment) less than 8cm.
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- Subjects with incisions exceeding 40 cm in length.
- Subjects with incisions that are actively bleeding unless homeostasis has been achieved (to be confirmed during surgery).
- Patients attending for a re-operation within the last 3 months.
- Patients undergoing a procedure as part of palliative care (to be confirmed during surgery).
- Patients with a systemic infection (that is not related to perforated bowel or peritonitis) at the time of surgery.
- Patients with a known history of poor compliance with medical treatment.
- Patients who also have a gynaecological procedure carried out during the colorectal procedure.
- Patients other than those with a disease known to affect the immune system that are on steroids or other immune modulators known to impact healing.
- Patients with a genetic or acquired healing defect.
- Exposure of blood vessels, organs, bone or tendon within the incision (to be confirmed during surgery).
- Subjects with a medical or physical condition that, in the opinion of the Investigator, would preclude safe subject participation in the study.
About this study
Official title: A Randomised Controlled Study to Compare Surgical Site Complication Incidence in Subjects Receiving PICO or Standard Care Following Colorectal Surgery
Surgical Site Complications (SSC's) are responsible for increased morbidity in patients undergoing surgery resulting in prolonged length of stay in the hospital while increasing treatment and hospital costs dramatically. Negative Pressure Wound Therapy (NPWT) use on closed incisions has been reported in the literature to reduce SSC's including Surgical Site Infections (SSI's), with many promising studies in general surgery, including some studies using single use NPWT. However, to date, there are very few randomised controlled trials (RCT's) using this intervention. When using PICOTM (NPWT) for this indication, patients may be discharged from hospital earlier, with the negative pressure incision management in place. This has implications in terms of cost savings for the health care system and enables the patient to be able to return to their normal daily routine more quickly. The hypothesis of this study is that PICO NPWT will reduce frequency of SSC's, in a 30 day follow up period, as compared to standard care in patients undergoing colorectal procedures.
- Conditions
- Wounds and Injuries
- Being tested
- PICO Softport V1.6, Standard Care
- Keywords
- Surgical incision, surgical complication, NPWT, negative pressure, colorectal surgery, dehisced
- Medical subject headings
- Wounds and Injuries, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICO Softport V1.6Device
PICO is a Single-Use Negative Pressure Wound Therapy (NPWT) System consisting of a small portable pump, 2 lithium batteries, 2 dressings and fixation strips. The system is capable of delivering up to 80 mm Hg negative pressure to a wound or surgical incision site and managing low to moderate levels of exudate or fluid generated by the wound or incision. The therapy may be administered for up to 2 weeks.
Standard CareOther
Care path normally used by the hospital
| Study group | Role | What they receive |
|---|---|---|
| PICO | Experimental | Single use NPWT (PICO Softport V1.6) Receives: Device: PICO Softport V1.6 |
| Standard care | Other | Gauze dressing, Film dressing, foam dressing, skin glue, no dressing Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of complications in each group
Measured: 30 days
Secondary outcomes (10)
Dehiscence incidence during a 30-day follow-up period
Measured: 30 days
Haematoma incidence during a 30-day follow-up period
Measured: 30 days
Seroma incidence during a 30-day follow-up
Measured: 30 days
Time to surgical incision closure
Measured: 30 days
Total length of hospital stay, including readmissions during a 30-day follow-up period
Measured: 30 days
Time to initial discharge during a 30-day follow-up period
Measured: 30 days
Total number of readmissions during a 30-day follow-up period
Measured: 30 days
To compare PICO against Standard Care for differences in Health Related Quality of Life (HRQoL) using SF-12 over the 14-day and 30-day follow-up period
Measured: 30 days
Overall per subject treatment cost for PICO and Standard Care
Measured: 30 days
Cost per Quality Adjusted Life Year (QALY) within a 30-day follow-up period
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 posted30 Aug 2016 (estimated)
- Study startJan 2017 (estimated)
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: Business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wounds and InjuriesStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Beate Hanson, MD, PhD, Study chair, Vice President, Global Clinical Strategy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02883010
- Sponsor's protocol ID
- CT1602PIC
- Status last verified
- Mar 2019
- First submitted
- 25 Aug 2016
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Study to Compare Surgical Site Complication Incidence in Subjects Receiving PICO or Standard Care Following Colorectal Surgery
- ClinicalTrials.gov ID
- NCT02883010
- Acronym / sponsor ID
- CT1602PIC
- Conditions
- Wounds and Injuries
- Keywords
- Surgical incision, surgical complication, NPWT, negative pressure, colorectal surgery, dehisced
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2017 (estimated)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 30 Aug 2016 (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.
Surgical Site Complications (SSC's) are responsible for increased morbidity in patients undergoing surgery resulting in prolonged length of stay in the hospital while increasing treatment and hospital costs dramatically. Negative Pressure Wound Therapy (NPWT) use on closed incisions has been reported in the literature to reduce SSC's including Surgical Site Infections (SSI's), with many promising studies in general surgery, including some studies using single use NPWT. However, to date, there are very few randomised controlled trials (RCT's) using this intervention. When using PICOTM (NPWT) for this indication, patients may be discharged from hospital earlier, with the negative pressure incision management in place. This has implications in terms of cost savings for the health care system and enables the patient to be able to return to their normal daily routine more quickly. The hypothesis of this study is that PICO NPWT will reduce frequency of SSC's, in a 30 day follow up period, as compared to standard care in patients undergoing colorectal procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PICO | Experimental | Device: PICO Softport V1.6Single use NPWT (PICO Softport V1.6) |
| Standard care | Other | Other: Standard CareGauze dressing, Film dressing, foam dressing, skin glue, no dressing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The subject or legal guardian must provide written informed consent (reference section 9.1).
- Subjects eighteen (18) years of age or older.
- Willing and able to make all required study visits.
- Able to follow instructions.
- Males or females.
Key exclusion criteria (17 listed)
- Contraindications or hypersensitivity to the use of the investigational product or its components (e.g., silicone adhesives and polyurethane films [direct contact with incision], acrylic adhesives [direct contact with skin], polyethylene fabrics and super-absorbent powders [polyacrylates]) within the dressing.
- Subjects with extremely fragile skin who require the use of SECURA non-sting barrier skin wipes and have hypersensitivity to the ingredients in the wipes.
- Participation in another clinical trial (with use of investigational medicinal product or medical device) within thirty (30) days of Visit 1 or during the study.
- Subjects with skin features (e.g., tattoos, pre-existing scarring) which, in the opinion of the Investigator, could interfere with the study assessments.
- Subjects who have participated previously in this clinical trial.
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 |
|---|---|---|
| PICO Softport V1.6PICO is a Single-Use Negative Pressure Wound Therapy (NPWT) System consisting of a small portable pump, 2 lithium batteries, 2 dressings and fixation strips. The system is capable of delivering up to 80 mm Hg negative pressure to a wound or surgical incision site and managing low to moderate levels of exudate or fluid generated by the wound or incision. The therapy may be administered for up to 2 weeks. | Device | PICO |
| Standard CareCare path normally used by the hospital | Other | Standard care |
Primary outcome
Number of complications in each group
Time frame: 30 days
10 secondary outcomes
Dehiscence incidence during a 30-day follow-up period
Time frame: 30 days
Haematoma incidence during a 30-day follow-up period
Time frame: 30 days
Seroma incidence during a 30-day follow-up
Time frame: 30 days
Time to surgical incision closure
Time frame: 30 days
Total length of hospital stay, including readmissions during a 30-day follow-up period
Time frame: 30 days
Time to initial discharge during a 30-day follow-up period
Time frame: 30 days
Total number of readmissions during a 30-day follow-up period
Time frame: 30 days
To compare PICO against Standard Care for differences in Health Related Quality of Life (HRQoL) using SF-12 over the 14-day and 30-day follow-up period
Time frame: 30 days
Overall per subject treatment cost for PICO and Standard Care
Time frame: 30 days
Cost per Quality Adjusted Life Year (QALY) within a 30-day follow-up period
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Beate Hanson, MD, PhD study chair
Vice President, Global Clinical Strategy
Questions about this trial
What is this clinical trial studying?
A study testing PICO Softport V1.6 in people with Wounds and Injuries, run by Smith & Nephew, Inc..
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 6 inclusion and 17 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: withdrawn, as of the sponsor's last update on 1 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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 complications in each group (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 1 Apr 2019.