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

• ClinicalTrials.gov Identifier: NCT03781206
• Recruitment Status: Recruiting
• First Posted: December 19, 2018
• Last Update Posted: February 5, 2021
• Sponsor: Istituto Clinico Humanitas
• Collaborator: Smith & Nephew, Inc.
• Information provided by (Responsible Party): Istituto Clinico Humanitas

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.

Condition or disease	Intervention/treatment	Phase
Stoma Site Infection	Device: PICO™ 7	Not Applicable

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Efficacy of Negative Pressure Wound Therapy (NPWT) for Prevention of Wound Infection and Improvement of Wound Healing After Stoma Reversal
• Actual Study Start Date: July 18, 2019
• Estimated Primary Completion Date: March 1, 2021
• Estimated Study Completion Date: June 1, 2021

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Standard of Care (SOC); After stoma reversal, patients of SOC group will be treated as for normal clinical practice, using a simple adhesive wound dressing.
Experimental: Negative Pressure Wound Therapy (NPWT); PICO™ 7 will be applied after stoma reversal	Device: PICO™ 7; 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.

Outcome Measures

Primary Outcome Measures :

1. Surgical Site Infection (SSI) rate comparison [ Time Frame: Post-operative day 7 ]
   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
2. Surgical Site Infection (SSI) rate comparison [ Time Frame: Post-operative day 30 ]
   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 :

1. Wound healing timing comparison [ Time Frame: Post-operative day 30 ]
   Wound healing is defined as complete tissue restoration, scar formation and absence of resected tissues and will be assessed by medical examination
2. Quality of life assessment [ Time Frame: Post-operative day 7 ]
   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'.
3. Quality of life assessment [ Time Frame: Post-operative day 30 ]
   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'.
4. Quality of life assessment [ Time Frame: Post-operative day 90 ]
   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'.
5. Quality of life assessment [ Time Frame: Post-operative day 180 ]
   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'.
6. Pain assessment [ Time Frame: Post-operative day 7 ]
   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).
7. Pain assessment [ Time Frame: Post-operative day 30 ]
   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).
8. Pain assessment [ Time Frame: Post-operative day 90 ]
   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).
9. Pain assessment [ Time Frame: Post-operative day 180 ]
   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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Contacts

Contact: Annalisa Maroli, PhD; +39 02 8224 7776; annalisa.maroli@humanitas.it

Locations

Italy

Humanitas Research Hospital; Recruiting

Rozzano, MI, Italy, 20089

Contact: Humanitas R Hospital 0282247776 annalisa.maroli@humanitas.it

Contact antonino.spinelli@humanitas.it

Principal Investigator: Antonino Spinelli, MD, PhD

Sponsors and Collaborators

Istituto Clinico Humanitas

Smith & Nephew, Inc.

Investigators

• Principal Investigator: Antonino Spinelli, MD, PhD; Istituto Clinico Humanitas

More Information

• Responsible Party: Istituto Clinico Humanitas
• ClinicalTrials.gov Identifier: NCT03781206
• Other Study ID Numbers: 824
• First Posted: December 19, 2018
• Last Update Posted: February 5, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Istituto Clinico Humanitas:

Stoma; Surgical Site Infection; Negative Pressure Wound Therapy

Additional relevant MeSH terms:

Infections