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Negative Pressure Wound Therapy for Wound Healing After Stoma Reversal (NESTOR)

Primary Purpose

Stoma Site Infection

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
PICO™ 7
Sponsored by
Istituto Clinico Humanitas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stoma Site Infection focused on measuring Stoma, Surgical Site Infection, Negative Pressure Wound Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age >18 years, any sex;
  • Patients who underwent elective open or laparoscopic rectal resection ostomy construction (loop/end ileostomy; loop/end colostomy) for either oncological and Inflammatory Bowel Disease (IBD) indications;
  • Normal water contrast enema prior to surgery;
  • Both neo-adjuvant and adjuvant treatment are allowed for cancer patients;
  • Both immunosuppressant and biological medications are allowed for IBD patients.

Exclusion Criteria:

  • Patients age at screening < 18 years;
  • Pregnant or breastfeeding women;
  • Neurodegenerative disorders or psychiatric diseases;
  • Contraindications or hypersensitivity to the use of the investigational product or its components;
  • Patients with skin features (e.g., tattoos, pre-existing scarring) which could interfere with the study assessments;
  • Patients with post-operative bleeding (to be assessed 24 hours after surgery).

Sites / Locations

  • Humanitas Research HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard of Care (SOC)

Negative Pressure Wound Therapy (NPWT)

Arm Description

After stoma reversal, patients of SOC group will be treated as for normal clinical practice, using a simple adhesive wound dressing.

PICO™ 7 will be applied after stoma reversal

Outcomes

Primary Outcome Measures

Surgical Site Infection (SSI) rate comparison
The rate of superficial (infections involving only the skin and subcutaneous tissue) or deep (infections involving the muscle and the fascia but not organ space) SSI will be assessed by medical examination
Surgical Site Infection (SSI) rate comparison
The rate of superficial (infections involving only the skin and subcutaneous tissue) or deep (infections involving the muscle and the fascia but not organ space) SSI will be assessed by medical examination

Secondary Outcome Measures

Wound healing timing comparison
Wound healing is defined as complete tissue restoration, scar formation and absence of resected tissues and will be assessed by medical examination
Quality of life assessment
Quality of life will be assessed using the EuroQol-5 Dimension-5 Levels (EQ5D5L) questionnaire. The EQ5D5L questionnaire comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The questionnaire also includes a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.
Quality of life assessment
Quality of life will be assessed using the EuroQol-5 Dimension-5 Levels (EQ5D5L) questionnaire. The EQ5D5L questionnaire comprises 5 dimensions (mobility, self) care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The questionnaire also includes a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.
Quality of life assessment
Quality of life will be assessed using the EuroQol-5 Dimension-5 Levels (EQ5D5L) questionnaire. The EQ5D5L questionnaire comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The questionnaire also includes a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.
Quality of life assessment
Quality of life will be assessed using the EuroQol-5 Dimension-5 Levels (EQ5D5L) questionnaire. The EQ5D5L questionnaire comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The questionnaire also includes a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.
Pain assessment
Pain will be measured using the McGill Pain questionnaire. The questionnaire presents a list of 78 words in 20 sections that are related to pain. The users mark the words that best describe their pain (multiple markings are allowed). Among the words, sections of these words signify different components of pain: Sensory (sections 1-10), Affective (sections 11-15), Evaluative (section 16), and Miscellaneous (sections 17-20).
Pain assessment
Pain will be measured using the McGill Pain questionnaire. The questionnaire presents a list of 78 words in 20 sections that are related to pain. The users mark the words that best describe their pain (multiple markings are allowed). Among the words, sections of these words signify different components of pain: Sensory (sections 1-10), Affective (sections 11-15), Evaluative (section 16), and Miscellaneous (sections 17-20).
Pain assessment
Pain will be measured using the McGill Pain questionnaire. The questionnaire presents a list of 78 words in 20 sections that are related to pain. The users mark the words that best describe their pain (multiple markings are allowed). Among the words, sections of these words signify different components of pain: Sensory (sections 1-10), Affective (sections 11-15), Evaluative (section 16), and Miscellaneous (sections 17-20).
Pain assessment
Pain will be measured using the McGill Pain questionnaire. The questionnaire presents a list of 78 words in 20 sections that are related to pain. The users mark the words that best describe their pain (multiple markings are allowed). Among the words, sections of these words signify different components of pain: Sensory (sections 1-10), Affective (sections 11-15), Evaluative (section 16), and Miscellaneous (sections 17-20).

Full Information

First Posted
December 13, 2018
Last Updated
February 2, 2021
Sponsor
Istituto Clinico Humanitas
Collaborators
Smith & Nephew, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03781206
Brief Title
Negative Pressure Wound Therapy for Wound Healing After Stoma Reversal
Acronym
NESTOR
Official Title
Efficacy of Negative Pressure Wound Therapy (NPWT) for Prevention of Wound Infection and Improvement of Wound Healing After Stoma Reversal
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 18, 2019 (Actual)
Primary Completion Date
March 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Clinico Humanitas
Collaborators
Smith & Nephew, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Stoma reversal is associated with high incidence of post-surgical complications, including Surgical Site Infections (SSI). Negative Pressure Wound Therapy (NPWT) has been successfully applied to surgical wound management, reducing the SSIs incidence. This is a randomized open-label trial to assess the efficacy of NPWT in decreasing the rate of SSI after stoma reversal.
Detailed Description
Stoma reversal after abdominal resection is associated with several complications, of which the most common is wound infection. Surgical Site Infections (SSI) usually result in increased long-term complications, such as incisional hernia, prolonged hospital stay, increased outpatients visits and medical costs. Negative-Pressure-Wound-Therapy (NPWT) is a technique using vacuum dressing, commonly used to promote surgical wound healing, but there is a significant lack of knowledge about its safety and efficacy in promoting wound healing after stoma closure. This is an interventional, randomized, open label trial to evaluate the safety and efficacy of the NPWT (PICO™ system, Smith&Nephew Healthcare, Hull, UK) on stoma wound compared to Standard of Care (SOC).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stoma Site Infection
Keywords
Stoma, Surgical Site Infection, Negative Pressure Wound Therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care (SOC)
Arm Type
No Intervention
Arm Description
After stoma reversal, patients of SOC group will be treated as for normal clinical practice, using a simple adhesive wound dressing.
Arm Title
Negative Pressure Wound Therapy (NPWT)
Arm Type
Experimental
Arm Description
PICO™ 7 will be applied after stoma reversal
Intervention Type
Device
Intervention Name(s)
PICO™ 7
Intervention Description
PICO™ system (Smith&Nephew Healthcare, Hull, UK) is a Single-Use Negative Pressure Wound Therapy (NPWT) System consisting of a small portable pump, 2 lithium batteries, 2 dressings and fixation strips.
Primary Outcome Measure Information:
Title
Surgical Site Infection (SSI) rate comparison
Description
The rate of superficial (infections involving only the skin and subcutaneous tissue) or deep (infections involving the muscle and the fascia but not organ space) SSI will be assessed by medical examination
Time Frame
Post-operative day 7
Title
Surgical Site Infection (SSI) rate comparison
Description
The rate of superficial (infections involving only the skin and subcutaneous tissue) or deep (infections involving the muscle and the fascia but not organ space) SSI will be assessed by medical examination
Time Frame
Post-operative day 30
Secondary Outcome Measure Information:
Title
Wound healing timing comparison
Description
Wound healing is defined as complete tissue restoration, scar formation and absence of resected tissues and will be assessed by medical examination
Time Frame
Post-operative day 30
Title
Quality of life assessment
Description
Quality of life will be assessed using the EuroQol-5 Dimension-5 Levels (EQ5D5L) questionnaire. The EQ5D5L questionnaire comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The questionnaire also includes a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.
Time Frame
Post-operative day 7
Title
Quality of life assessment
Description
Quality of life will be assessed using the EuroQol-5 Dimension-5 Levels (EQ5D5L) questionnaire. The EQ5D5L questionnaire comprises 5 dimensions (mobility, self) care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The questionnaire also includes a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.
Time Frame
Post-operative day 30
Title
Quality of life assessment
Description
Quality of life will be assessed using the EuroQol-5 Dimension-5 Levels (EQ5D5L) questionnaire. The EQ5D5L questionnaire comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The questionnaire also includes a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.
Time Frame
Post-operative day 90
Title
Quality of life assessment
Description
Quality of life will be assessed using the EuroQol-5 Dimension-5 Levels (EQ5D5L) questionnaire. The EQ5D5L questionnaire comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The questionnaire also includes a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'.
Time Frame
Post-operative day 180
Title
Pain assessment
Description
Pain will be measured using the McGill Pain questionnaire. The questionnaire presents a list of 78 words in 20 sections that are related to pain. The users mark the words that best describe their pain (multiple markings are allowed). Among the words, sections of these words signify different components of pain: Sensory (sections 1-10), Affective (sections 11-15), Evaluative (section 16), and Miscellaneous (sections 17-20).
Time Frame
Post-operative day 7
Title
Pain assessment
Description
Pain will be measured using the McGill Pain questionnaire. The questionnaire presents a list of 78 words in 20 sections that are related to pain. The users mark the words that best describe their pain (multiple markings are allowed). Among the words, sections of these words signify different components of pain: Sensory (sections 1-10), Affective (sections 11-15), Evaluative (section 16), and Miscellaneous (sections 17-20).
Time Frame
Post-operative day 30
Title
Pain assessment
Description
Pain will be measured using the McGill Pain questionnaire. The questionnaire presents a list of 78 words in 20 sections that are related to pain. The users mark the words that best describe their pain (multiple markings are allowed). Among the words, sections of these words signify different components of pain: Sensory (sections 1-10), Affective (sections 11-15), Evaluative (section 16), and Miscellaneous (sections 17-20).
Time Frame
Post-operative day 90
Title
Pain assessment
Description
Pain will be measured using the McGill Pain questionnaire. The questionnaire presents a list of 78 words in 20 sections that are related to pain. The users mark the words that best describe their pain (multiple markings are allowed). Among the words, sections of these words signify different components of pain: Sensory (sections 1-10), Affective (sections 11-15), Evaluative (section 16), and Miscellaneous (sections 17-20).
Time Frame
Post-operative day 180

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age >18 years, any sex; Patients who underwent elective open or laparoscopic rectal resection ostomy construction (loop/end ileostomy; loop/end colostomy) for either oncological and Inflammatory Bowel Disease (IBD) indications; Normal water contrast enema prior to surgery; Both neo-adjuvant and adjuvant treatment are allowed for cancer patients; Both immunosuppressant and biological medications are allowed for IBD patients. Exclusion Criteria: Patients age at screening < 18 years; Pregnant or breastfeeding women; Neurodegenerative disorders or psychiatric diseases; Contraindications or hypersensitivity to the use of the investigational product or its components; Patients with skin features (e.g., tattoos, pre-existing scarring) which could interfere with the study assessments; Patients with post-operative bleeding (to be assessed 24 hours after surgery).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annalisa Maroli, PhD
Phone
+39 02 8224 7776
Email
annalisa.maroli@humanitas.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonino Spinelli, MD, PhD
Organizational Affiliation
Istituto Clinico Humanitas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Humanitas Research Hospital
City
Rozzano
State/Province
MI
ZIP/Postal Code
20089
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Humanitas R Hospital
Phone
0282247776
Email
annalisa.maroli@humanitas.it
Ext
Spinelli
Email
antonino.spinelli@humanitas.it
First Name & Middle Initial & Last Name & Degree
Antonino Spinelli, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Negative Pressure Wound Therapy for Wound Healing After Stoma Reversal

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