Negative Pressure Wound Therapy With Instillation of Saline Solution Versus Collagenase Ointment in Full-thickness Wounds

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-12

Study Completion Date

2022-04-19

Brief Summary

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Evaluation of wound bed surface area containing clean, healthy viable tissue in full-thickness wounds.

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Detailed Description

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This study evaluates changes in wound bed surface area of clean, healthy viable tissue in subjects with full-thickness wounds using negative pressure wound therapy with instillation of saline solution versus a collagenase ointment.

Conditions

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Wounds and Injuries Wound Healing Granulation Tissue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Negative Pressure Therapy w/ instillation and dwell (NPWTi-d)

V.A.C. VeraFlo Cleanse Choice Dressing, V.A.C.Ulta Therapy Unit and saline solution

Group Type EXPERIMENTAL

Negative Pressure Therapy w/ instillation and dwell (NPWTi-d)

Intervention Type DEVICE

Negative Pressure Therapy at -125mmHg for 3.5 hours followed by 10 minute dwell of saline solution for 6-9 days.

Collagenase Ointment

Group Type ACTIVE_COMPARATOR

Collagenase Ointment

Intervention Type BIOLOGICAL

Collagenase ointment applied daily to the wound and covered with secondary dressing for 6-9 days.

Interventions

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Negative Pressure Therapy w/ instillation and dwell (NPWTi-d)

Negative Pressure Therapy at -125mmHg for 3.5 hours followed by 10 minute dwell of saline solution for 6-9 days.

Intervention Type DEVICE

Collagenase Ointment

Collagenase ointment applied daily to the wound and covered with secondary dressing for 6-9 days.

Intervention Type BIOLOGICAL

Other Intervention Names

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V.A.C. VeraFlo Cleanse Choice V.A.C.Ulta Therapy Unit

Eligibility Criteria

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Inclusion Criteria

The Subject:

1. is anticipated to be hospitalized for the duration of treatment (minimum of 6 days).
2. is ≥ 18 years of age.
3. or their legally authorized representative is able to provide informed consent.
4. has been diagnosed with a wound (eg, chronic, acute, traumatic, or dehisced wounds) and/or ulcer (ie, full- thickness wounds) that meets the following criteria:

1. total surface area measuring ≥ 16 cm2, including a minimum width of 2 cm (before removal of eschar at the bedside and excluding undermining).
2. \< 20 cm across (edge-to-edge) at any point perpendicular to the wound edges.
5. has, in the opinion of the investigator, no more than 2/3 of the wound bed surface area considered to be clean, healthy, and viable. If eschar is present at baseline, it must be removed by bedside debridement prior to assessing the percentage of clean, healthy, and viable wound bed.
6. has a negative urine or serum pregnancy test at screening (if female and has potential for pregnancy) and is willing to take precautionary measures to prevent pregnancy during the duration of the study (up to 9 days).

Exclusion Criteria

The Subject:

1. has been diagnosed with malignancy in the wound.
2. has untreated osteomyelitis.
3. has an untreated systemic infection.
4. has active cellulitis in the periwound area.
5. has a known allergy or hypersensitivity to study materials: collagenase ointment, dressing(s), and/or dressing components such as acrylic adhesives or polyurethane.
6. has, in the opinion of the investigator, a clinically significant condition that would impair the Subject's ability to comply with the study procedures.
7. has had radiation directly to the wound area.
8. has been diagnosed with a major vascular deficit limiting arterial inflow to the wound region, as determined by the Investigator's interpretation of the Subject's medical history.
9. has eschar in the wound that cannot be removed by bedside sharp and/or mechanical debridement.
10. is participating in another interventional clinical trial for the duration of the study.
11. has unexplored fistulas in the wound or fistulas in the wound that connect to other body cavities.
12. has a wound with any tunneling present.
13. has inadequate hemostasis at the wound site, as determined by the investigator.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No