Closed Incision Negative Pressure Wound Therapy vs. Foam as Post Operative Dressing

NCT05427916 | Terminated Results FDA Device

• 1 other identifier: STUDY-22-00329
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective is to assess the frequency of a wound healing complication, in a closed incisional wound in a "high risk" surgical incision when treated with Negative Pressure Wound Therapy versus a highly absorbent antimicrobial post - operative absorbent dressing.

Conditions

Diabetes; Morbid Obesity; Lymphedema; Orthopedic Disorder

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Healing Complication

  Healing complications are defined as the presence of at least one of the following conditions: infection (superficial or deep), dehiscence (partial, superficial, or deep), or delayed healing (incision not 100% closed within 7 days of the first surgical procedure)

  21 days

Secondary Outcomes (9)

• Number of Skin Necrosis Complications

  90 days

• Number of Cellulitis Complications

  90 days

• Number of Abscess Complications

  90 days

• Number of Suture Abscess Complications

  90 days

• Number of Seroma Complications

  90 days

Study Arms (2)

Negative Pressure Wound Therapy

EXPERIMENTAL

Negative pressure to the incision site and managing exudate generated by the incision.

Device: Avance Solo

Optifoam

ACTIVE COMPARATOR

This foam is standard of care and is currently stocked by the operating rooms at Mount Sinai hospital and indicated for use in high risk wounds

Other: Optifoam

Interventions

Avance Solo DEVICE

Avance® Solo will include the collective description for a complete device capable of delivering negative pressure to the incision site and managing exudate generated by the incision.

Negative Pressure Wound Therapy

Optifoam OTHER

Optifoam is a silicone backed foam that is conformable, with a border that is waterproof, flexible and breathable for increased comfort, with a wear time of up to seven days. It is a standard of care product that is given to patients for surgical wounds.

Optifoam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must be at least 18 years of age.
• Males and females - provided they are not pregnant and if of reproductive age are using contraception.
• Have a closed surgical incision post-surgery/closure (\<24 hours after).
• The patient is able to understand the evaluation and is willing to consent to the evaluation.
• Undergoing appropriate: wound "high risk" surgery.
• Foot and ankle surgery.
• Vascular groin incision.
• Long leg vein harvest incision.
• Closed forefoot and major amputation surgery.
• Possibly: breast augmentation and reduction surgery.
• HIV and hepatitis positive patients will not be excluded from this study.
• Renal failure patients will not be excluded.
• Patient on metabolic agent, immunosuppressants, or steroid therapy will not be excluded from this study.

You may not qualify if:

• Incisions in excess of effective dressing pad size provided.
• Patients with a known history of poor compliance with medical treatment.
• Patients who have participated in this trial previously and who were withdrawn.
• Patients with known allergies to product components (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).
• Incisions where daily inspection is required underneath the dressing.
• Incisions which have an infection which is not being treated with systemic antibiotics.
• Incisions which are actively bleeding.
• Exposure of blood vessels, organs, bone or tendon at the base of the reference incision.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Lauren Rodio

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Obesity, Morbid; Lymphedema; Musculoskeletal Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lymphatic Diseases; Hemic and Lymphatic Diseases

Results Point of Contact

• Title: John C Lantis II
• Organization: Icahn School of Medicine at Mount Sinai

John.Lantis@mountsinai.org

(212) 523-4797

Study Officials

• John C Lantis, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 22, 2022
• Study Start: July 12, 2022
• Primary Completion: February 17, 2023
• Study Completion: February 17, 2023
• Last Updated: March 13, 2024
• Results First Posted: March 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Anyone who wishes to access the data. Any purpose. Proposals should be directed to john.lantis@mountsinai.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)