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

NCT02479542 | Withdrawn

• 1 other identifier: SU 34186
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Wounds and Injuries

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  5-19 days following application of dressing

Secondary Outcomes (1)

• Rate of Wound Contraction

  5-19 days following application of dressing

Study Arms (2)

Standard Gauze Dressing

ACTIVE COMPARATOR

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

WiCare NPWT dressing

EXPERIMENTAL

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

Interventions

Standard Gauze Dressing OTHER

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.

Standard Gauze Dressing

WiCare NPWT dressing DEVICE

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.

WiCare NPWT dressing

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Related Publications (15)

• Saxena V, Hwang CW, Huang S, Eichbaum Q, Ingber D, Orgill DP. Vacuum-assisted closure: microdeformations of wounds and cell proliferation. Plast Reconstr Surg. 2004 Oct;114(5):1086-96; discussion 1097-8. doi: 10.1097/01.prs.0000135330.51408.97.

  PMID: 15457017 BACKGROUND

• Borgquist O, Gustafsson L, Ingemansson R, Malmsjo M. Micro- and macromechanical effects on the wound bed of negative pressure wound therapy using gauze and foam. Ann Plast Surg. 2010 Jun;64(6):789-93. doi: 10.1097/SAP.0b013e3181ba578a.

  PMID: 20489409 BACKGROUND

• Chariker ME, Gerstle TL, Morrison CS. An algorithmic approach to the use of gauze-based negative-pressure wound therapy as a bridge to closure in pediatric extremity trauma. Plast Reconstr Surg. 2009 May;123(5):1510-1520. doi: 10.1097/PRS.0b013e3181a20563.

  PMID: 19407624 BACKGROUND

• Orgill DP, Bayer LR. Update on negative-pressure wound therapy. Plast Reconstr Surg. 2011 Jan;127 Suppl 1:105S-115S. doi: 10.1097/PRS.0b013e318200a427.

  PMID: 21200280 BACKGROUND

• Wilkes R, Zhao Y, Kieswetter K, Haridas B. Effects of dressing type on 3D tissue microdeformations during negative pressure wound therapy: a computational study. J Biomech Eng. 2009 Mar;131(3):031012. doi: 10.1115/1.2947358.

  PMID: 19154071 BACKGROUND

• Malmsjo M, Ingemansson R, Martin R, Huddleston E. Negative-pressure wound therapy using gauze or open-cell polyurethane foam: similar early effects on pressure transduction and tissue contraction in an experimental porcine wound model. Wound Repair Regen. 2009 Mar-Apr;17(2):200-5. doi: 10.1111/j.1524-475X.2009.00461.x.

  PMID: 19320888 BACKGROUND

• Malmsjo M, Ingemansson R, Martin R, Huddleston E. Wound edge microvascular blood flow: effects of negative pressure wound therapy using gauze or polyurethane foam. Ann Plast Surg. 2009 Dec;63(6):676-81. doi: 10.1097/SAP.0b013e31819ae01b.

  PMID: 19887926 BACKGROUND

• Dorafshar AH, Franczyk M, Gottlieb LJ, Wroblewski KE, Lohman RF. A prospective randomized trial comparing subatmospheric wound therapy with a sealed gauze dressing and the standard vacuum-assisted closure device. Ann Plast Surg. 2012 Jul;69(1):79-84. doi: 10.1097/SAP.0b013e318221286c.

  PMID: 21712704 BACKGROUND

• Dunn R, Hurd T, Chadwick P, Cote J, Cockwill J, Mole T, Smith J. Factors associated with positive outcomes in 131 patients treated with gauze-based negative pressure wound therapy. Int J Surg. 2011;9(3):258-62. doi: 10.1016/j.ijsu.2010.12.005. Epub 2010 Dec 25.

  PMID: 21187174 BACKGROUND

• Campbell PE, Smith GS, Smith JM. Retrospective clinical evaluation of gauze-based negative pressure wound therapy. Int Wound J. 2008 Jun;5(2):280-6. doi: 10.1111/j.1742-481X.2008.00485.x.

  PMID: 18494633 BACKGROUND

• Jeffery SL. Advanced wound therapies in the management of severe military lower limb trauma: a new perspective. Eplasty. 2009 Jul 21;9:e28.

  PMID: 19696875 BACKGROUND

• Lee HJ, Kim JW, Oh CW, Min WK, Shon OJ, Oh JK, Park BC, Ihn JC. Negative pressure wound therapy for soft tissue injuries around the foot and ankle. J Orthop Surg Res. 2009 May 9;4:14. doi: 10.1186/1749-799X-4-14.

  PMID: 19426531 BACKGROUND

• Bagheri Nejad S, Allegranzi B, Syed SB, Ellis B, Pittet D. Health-care-associated infection in Africa: a systematic review. Bull World Health Organ. 2011 Oct 1;89(10):757-65. doi: 10.2471/BLT.11.088179. Epub 2011 Jul 20.

  PMID: 22084514 BACKGROUND

• Armstrong DG, Lavery LA; Diabetic Foot Study Consortium. Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial. Lancet. 2005 Nov 12;366(9498):1704-10. doi: 10.1016/S0140-6736(05)67695-7.

  PMID: 16291063 BACKGROUND

• Morykwas MJ, Argenta LC, Shelton-Brown EI, McGuirt W. Vacuum-assisted closure: a new method for wound control and treatment: animal studies and basic foundation. Ann Plast Surg. 1997 Jun;38(6):553-62. doi: 10.1097/00000637-199706000-00001.

  PMID: 9188970 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Sherry M Wren, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Brannon Weeks, BA

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 21, 2015
• First Posted: June 24, 2015
• Study Start: June 1, 2015
• Primary Completion: June 1, 2015
• Study Completion: July 1, 2015
• Last Updated: April 26, 2017

Record last verified: 2015-11