Comparison of Surgical Incision Complications in Patients Receiving PICO or Standard Care Following Colorectal Surgery
Primary Purpose
Wounds and Injuries
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PICO Softport V1.6
Standard Care
Sponsored by
About this trial
This is an interventional prevention trial for Wounds and Injuries focused on measuring Surgical incision, surgical complication, NPWT, negative pressure, colorectal surgery, dehisced
Eligibility Criteria
INCLUSION CRITERIA
- 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.
EXCLUSION CRITERIA
- 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.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
PICO
Standard care
Arm Description
Single use NPWT (PICO Softport V1.6)
Gauze dressing, Film dressing, foam dressing, skin glue, no dressing
Outcomes
Primary Outcome Measures
Number of complications in each group
Secondary Outcome Measures
Dehiscence incidence during a 30-day follow-up period
Haematoma incidence during a 30-day follow-up period
Seroma incidence during a 30-day follow-up
Time to surgical incision closure
Total length of hospital stay, including readmissions during a 30-day follow-up period
Time to initial discharge during a 30-day follow-up period
Total number of readmissions during a 30-day follow-up period
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
Overall per subject treatment cost for PICO and Standard Care
Cost per Quality Adjusted Life Year (QALY) within a 30-day follow-up period
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02883010
Brief Title
Comparison of Surgical Incision Complications in Patients Receiving PICO or Standard Care Following Colorectal Surgery
Official Title
A Randomised Controlled Study to Compare Surgical Site Complication Incidence in Subjects Receiving PICO or Standard Care Following Colorectal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Business decision
Study Start Date
January 2017 (Anticipated)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Smith & Nephew, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds and Injuries
Keywords
Surgical incision, surgical complication, NPWT, negative pressure, colorectal surgery, dehisced
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PICO
Arm Type
Experimental
Arm Description
Single use NPWT (PICO Softport V1.6)
Arm Title
Standard care
Arm Type
Other
Arm Description
Gauze dressing, Film dressing, foam dressing, skin glue, no dressing
Intervention Type
Device
Intervention Name(s)
PICO Softport V1.6
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
Care path normally used by the hospital
Primary Outcome Measure Information:
Title
Number of complications in each group
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Dehiscence incidence during a 30-day follow-up period
Time Frame
30 days
Title
Haematoma incidence during a 30-day follow-up period
Time Frame
30 days
Title
Seroma incidence during a 30-day follow-up
Time Frame
30 days
Title
Time to surgical incision closure
Time Frame
30 days
Title
Total length of hospital stay, including readmissions during a 30-day follow-up period
Time Frame
30 days
Title
Time to initial discharge during a 30-day follow-up period
Time Frame
30 days
Title
Total number of readmissions during a 30-day follow-up period
Time Frame
30 days
Title
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
Title
Overall per subject treatment cost for PICO and Standard Care
Time Frame
30 days
Title
Cost per Quality Adjusted Life Year (QALY) within a 30-day follow-up period
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA
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.
EXCLUSION CRITERIA
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beate Hanson, MD, PhD
Organizational Affiliation
Vice President, Global Clinical Strategy
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison of Surgical Incision Complications in Patients Receiving PICO or Standard Care Following Colorectal Surgery
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