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

NCT03722485 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-10-16

Study results available
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Summary

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

Conditions

  • Wounds and Injuries
  • Wound Healing
  • Granulation Tissue

Interventions

DEVICE

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.

BIOLOGICAL

Collagenase Ointment

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

Sponsors & Collaborators

  • 3M

    collaborator INDUSTRY

  • KCI USA, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-12
Primary Completion
2022-04-19
Completion
2022-04-19
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03722485 on ClinicalTrials.gov