Addition of Negative Pressure Wound Therapy to Standard Gauze Dressings for Acute Wounds in a Limited-Resource Setting

April 24, 2017 updated by: Sherry M. Wren MD, Stanford University

Randomized Trial Comparing the Negative Pressure Wound Therapy to Standard Gauze Dressings for Acute Wounds in Mbingo Baptist Hospital, Cameroon

The worldwide prevalence of open wounds is estimated to be approximately 200 million per year. Negative Pressure Wound Therapy (NPWT), the application of a controlled vacuum to an open wound cavity, has been clinically demonstrated in developed nations to speed the healing time of open wounds by a factor of two or more, and to aid in complete recovery with less scar tissue. Use of NPWT devices has not been feasible in an limited-resource settings due to cost, bulk, and requirement for consistent electricity. This study aims to follow up prior clinical studies that have established the safety and efficacy of simplified NPWT, by assessing changes in wound closure time and wound contraction rate when simplified NPWT is used in a limited-resource setting.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Hypothesis:

Application of WiCare Wound Pump to a standard gauze dressing will result in faster time to definitive wound closure and rate of healing in acute wounds from trauma, infection, or surgery as compared to standard gauze dressing without negative pressure.

Study Design A. Single center prospective trial to be conducted at Mbingo Baptist Hospital (MBH) a multispecialty hospital located in North-West Cameroon that provides complex surgical care.

B. Phase II C. Two arm trial with all patients with eligible wounds offered entrance into Phase II trial D. Blinding: Non E. Indication and patient population: Acute wounds secondary to trauma, infection, or surgical excision in adult patients (>15 year old) F. Sample size: 100 total; based on Schoenfeld's Method to compare two-sample Log-Rank Test with Power of 80%, significance level=5% G. Random Permuted Blocks: Patients will be randomized in blocks of 4 using the following schema Treatment A) WiCare, Treatment B) Standard Dressing: AABB, ABAB, BAAB, BABA, BBAA, and ABBA.

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must be at least 15 years of age,
  • Acute wounds <21 days from any soft tissue traumatic, surgical, or infectious cause.

  • Wound size must be either

    1. a minimum of 25 sq cm in cross dimension with a minimum wound depth of 1 cm at the deepest point or
    2. a minimum of 16 sq cm in cross dimension with a minimum depth of 1.5 cm at deepest point.
  • Wounds must have been cleaned and debrided of all debris, foreign body contamination (dirt, grass, bone fragments, other debris), necrotic tissue, and pus
  • Wound should be considered stable (not evoloving) and ready for dressing changes every 72hours.
  • Necrotizing soft tissue infection wounds will only be considered after control of infection through medical and surgical treatment and the wound stable enough for a dressing change every 72 hours.
  • Aamputation stump wounds can be included if all other criteria fulfilled.

Exclusion Criteria:

  • A wound that would be able to be closed primarily or within 5 days through suture closure, flap rotation or immediate skin graft coverage.
  • A wound greater than or equal to 21 cm in either length or width at the initial measurement.
  • A wound in the perineum: defined by the pubic bone anteriorly and the anus posteriorly.
  • A wound with a visible blood vessel of >3mm.
  • The presence of known cancer in the wound.
  • Acute burns or burns with skin grafts wound.
  • Latex allergy.
  • Expected mortality within 30 days of admission from co-exisitng medical or surgical condition.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Gauze Dressing
Patients with wounds that meet eligibility criteria will be randomized, if randomized to the Standard Gauze Dressing Arm, a saline moistened sterile gauze will be packed into the wound with dry gauze and either tape or other means will be used to secure the dressing. The dressing will be changed daily and measured and photodocumented every 72 hours with the Wound Zoom system.
Other: Standard Gauze Dressing
Following consenting of participant, the wound will be photographed with the Wound Zoom imaging system and measured for greatest length, width, and depth. For patients randomized to the control arm, only standard gauze dressings will be applied and changed daily. Wounds with the standard gauze dressings will be photo-documented and measured with the same variables every 72 hours. Wounds and dressing will be evaluated daily for drainage, exudate, presence of infection, and gauze dressings will be changed daily.
Experimental: WiCare NPWT dressing
Patients with wounds that meet eligibility criteria will be randomized, if randomized to the WiCare NPWT Dressing Arm, a saline moistened sterile gauze will be packed into the wound and then the WiCare dressing and wound pump will be placed on the wound. The dressing will be changed, measured and photodocumented every 72 hours with the Wound Zoom system.
Device: WiCare NPWT dressing
Following consenting of participant, the wound will be photographed with the Wound Zoom imaging system and measured for greatest length, width, and depth. For patients randomized to the simplified NPWT arm, the standard gauze dressing will be placed then the the WiCare NPWT dressing will be applied. Wounds and WiCare NPWT device will be evaluated daily for drainage, exudate, presence of infection, drainage in pump, integrity of air tight seal. Wounds will be changed by protocol with photo documentation every 72 hours for a total of 18 days or achievement of primary endpoint.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Wound Closure
Time Frame: 5-19 days following application of dressing
The effect of simplified negative pressure wound therapy device use on the time to definitive wound closure or time to wound becoming appropriate for discharge for eschar formation.
5-19 days following application of dressing

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Wound Contraction
Time Frame: 5-19 days following application of dressing
The rate of wound contraction with NPWT for those wounds that do not reach definitive wound closure by study endpoint.
5-19 days following application of dressing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Sherry M Wren, MD, Stanford University
  • Principal Investigator: Brannon Weeks, BA, Stanford University

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

June 21, 2015

First Submitted That Met QC Criteria

June 23, 2015

First Posted (Estimate)

June 24, 2015

Study Record Updates

Last Update Posted (Actual)

April 26, 2017

Last Update Submitted That Met QC Criteria

April 24, 2017

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU 34186

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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