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

Primary Purpose

Wounds and Injuries

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Standard Gauze Dressing

WiCare NPWT dressing

About this trial

This is an interventional treatment trial for Wounds and Injuries focused on measuring Negative-Pressure Wound Therapy, Wound Healing, Global Health, Cameroon

Eligibility Criteria

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

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Gauze Dressing

WiCare NPWT dressing

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Time to Wound Closure

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.

Secondary Outcome Measures

Rate of Wound Contraction

The rate of wound contraction with NPWT for those wounds that do not reach definitive wound closure by study endpoint.

Full Information

NCT ID

NCT02479542

First Posted

June 21, 2015

Last Updated

April 24, 2017

Sponsor

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT02479542

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Regulatory issues

Study Start Date

June 2015 (undefined)

Primary Completion Date

June 1, 2015 (Actual)

Study Completion Date

July 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wounds and Injuries

Keywords

Negative-Pressure Wound Therapy, Wound Healing, Global Health, Cameroon

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard Gauze Dressing

Arm Type

Active Comparator

Arm Description

Arm Title

WiCare NPWT dressing

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Standard Gauze Dressing

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

WiCare NPWT dressing

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time to Wound Closure

Description

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.

Time Frame

5-19 days following application of dressing

Secondary Outcome Measure Information:

Title

Rate of Wound Contraction

Description

The rate of wound contraction with NPWT for those wounds that do not reach definitive wound closure by study endpoint.

Time Frame

5-19 days following application of dressing

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 a minimum of 25 sq cm in cross dimension with a minimum wound depth of 1 cm at the deepest point or 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sherry M Wren, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Brannon Weeks, BA

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

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15457017

Citation

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Citation

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

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