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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05427916
• Other study ID #: STUDY-22-00329
• Status: Terminated
• Phase: N/A
• Start date: July 12, 2022
• Est. completion date: February 17, 2023

Study information

• Verified date: February 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: February 17, 2023
• Est. primary completion date: February 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Lymphedema
• Morbid Obesity
• Musculoskeletal Diseases
• Obesity, Morbid
• Orthopedic Disorder

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Lauren Rodio	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Skin Necrosis Complications	Incisional complication as assessed by number of skin necrosis complications	90 days
Secondary	Number of Cellulitis Complications	Incisional complication as assessed by number of cellulitis complications	90 days
Secondary	Number of Abscess Complications	Incisional complication as assessed by number of abscess complications	90 days
Secondary	Number of Suture Abscess Complications	Incisional complication as assessed by number of suture abscess complications	90 days
Secondary	Number of Seroma Complications	Incisional complication as assessed by number of seroma complications	90 days
Secondary	Number of Periwound Edema Complications	Incisional complication as assessed by number of periwound edema complications	90 days
Secondary	Number of Hematoma Complications	Incisional complication as assessed by number of hematoma complications	90 days
Secondary	Pain During Dressing Changes	Patient reported as none, mild, moderate, or severe	90 days
Secondary	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