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

Prospective Randomized Evaluation of the Effect of Avance® Solo Negative Pressure Wound Therapy System or Optifoam® Gentle Post-Op Dressing on "High Risk" Closed Surgical Incisions; Freedom From Wound Complication Study

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.

Study Overview

• Status: Terminated
• Conditions: Diabetes; Lymphedema; Morbid Obesity; Orthopedic Disorder
• Intervention / Treatment: Device: Avance Solo; Other: Optifoam

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • Lauren Rodio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Negative Pressure Wound Therapy; Negative pressure to the incision site and managing exudate generated by the incision.	Device: 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.
Active Comparator: 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	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	Patient Satisfaction Question that the patient will rank on a min/max scale of 0 to 7, higher score indicates higher satisfaction	90 days
Number of Skin Necrosis Complications	Incisional complication as assessed by number of skin necrosis complications	90 days
Number of Cellulitis Complications	Incisional complication as assessed by number of cellulitis complications	90 days
Number of Abscess Complications	Incisional complication as assessed by number of abscess complications	90 days
Number of Suture Abscess Complications	Incisional complication as assessed by number of suture abscess complications	90 days
Number of Seroma Complications	Incisional complication as assessed by number of seroma complications	90 days
Number of Periwound Edema Complications	Incisional complication as assessed by number of periwound edema complications	90 days
Number of Hematoma Complications	Incisional complication as assessed by number of hematoma complications	90 days
Pain During Dressing Changes	Patient reported as none, mild, moderate, or severe	90 days

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: John C Lantis, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2022
• Primary Completion (Actual): February 17, 2023
• Study Completion (Actual): February 17, 2023

Study Registration Dates

• First Submitted: June 16, 2022
• First Submitted That Met QC Criteria: June 16, 2022
• First Posted (Actual): June 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Lymphedema; Obesity, Morbid; Musculoskeletal Diseases
• Other Study ID Numbers: STUDY-22-00329

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes