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

NCT ID: NCT05427916

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-12
• Study Completion Date: 2023-02-17

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.

Detailed Description

A healing complication is defined as 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), drainage form the wound after 96 hours post operatively.

The secondary objectives are to assess any changes in the following assessments of the surgical incision weekly over the treatment period:

• Surrounding skin condition
• Incision complications, infection or clinical signs of infection
• to assess the number and type of these complications individually including other postsurgical complications: skin necrosis, cellulitis, abscess, suture abscess, seroma, periwound edema or hematoma occurring within 21, 42, and 90 days postoperatively
• Pain during dressing changes

Assessment of the following at dressing changes:

• Duration/wear time
• Ease of use; difficulty with sleep
• Damage to surrounding skin on removal
• Assessment of re-epithelialization/closure
• Patient comfort during wear; ease of ambulation
• Conformability of dressing
• Exudate management
• Reasons for removal

To assess the overall comparison of Avance® Solo to the standard of care foam dressing.

Conditions

Diabetes; Morbid Obesity; Lymphedema; Orthopedic Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Negative Pressure Wound Therapy

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

Group Type: EXPERIMENTAL

Avance Solo

Intervention Type: 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.

Optifoam

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

Group Type: ACTIVE_COMPARATOR

Optifoam

Intervention Type: 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.

Interventions

Avance Solo

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.

Intervention Type: DEVICE

Optifoam

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

John Lantis

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

John C Lantis, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Lauren Rodio

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY-22-00329

Identifier Type: -

Identifier Source: org_study_id