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

Primary Purpose

Diabetes, Morbid Obesity, Lymphedema

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Avance Solo
Optifoam
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

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

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  • Patients who have participated in this trial previously and who were withdrawn.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.

Sites / Locations

  • Lauren Rodio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Negative Pressure Wound Therapy

Optifoam

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Number of skin necrosis complications
Incisional complication as assessed by number of skin necrosis complications
Number of cellulitis complications
Incisional complication as assessed by number of cellulitis complications
Number of abscess complications
Incisional complication as assessed by number of abscess complications
Number of suture abscess complications
Incisional complication as assessed by number of suture abscess complications
Number of seroma complications
Incisional complication as assessed by number of seroma complications
Number of periwound edema complications
Incisional complication as assessed by number of periwound edema complications
Number of hematoma complications
Incisional complication as assessed by number of hematoma complications
Pain during dressing changes
Patient reported as none, mild, moderate, or severe
Patient Satisfaction
Patient Satisfaction Question that the patient will rank on a min/max scale of 0 to 7, higher score indicates higher satisfaction

Full Information

First Posted
June 16, 2022
Last Updated
May 24, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT05427916
Brief Title
Closed Incision Negative Pressure Wound Therapy vs. Foam as Post Operative Dressing
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Site decided not to continue
Study Start Date
July 12, 2022 (Actual)
Primary Completion Date
February 17, 2023 (Actual)
Study Completion Date
February 17, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Morbid Obesity, Lymphedema, Orthopedic Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Negative Pressure Wound Therapy
Arm Type
Experimental
Arm Description
Negative pressure to the incision site and managing exudate generated by the incision.
Arm Title
Optifoam
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Avance Solo
Intervention Description
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
Other
Intervention Name(s)
Optifoam
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants with Healing Complication
Description
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)
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Number of skin necrosis complications
Description
Incisional complication as assessed by number of skin necrosis complications
Time Frame
90 days
Title
Number of cellulitis complications
Description
Incisional complication as assessed by number of cellulitis complications
Time Frame
90 days
Title
Number of abscess complications
Description
Incisional complication as assessed by number of abscess complications
Time Frame
90 days
Title
Number of suture abscess complications
Description
Incisional complication as assessed by number of suture abscess complications
Time Frame
90 days
Title
Number of seroma complications
Description
Incisional complication as assessed by number of seroma complications
Time Frame
90 days
Title
Number of periwound edema complications
Description
Incisional complication as assessed by number of periwound edema complications
Time Frame
90 days
Title
Number of hematoma complications
Description
Incisional complication as assessed by number of hematoma complications
Time Frame
90 days
Title
Pain during dressing changes
Description
Patient reported as none, mild, moderate, or severe
Time Frame
90 days
Title
Patient Satisfaction
Description
Patient Satisfaction Question that the patient will rank on a min/max scale of 0 to 7, higher score indicates higher satisfaction
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John C Lantis, MD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lauren Rodio
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 xxx@yyy. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link to be included in the URL field below).

Learn more about this trial

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

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