Regulatory issues

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.

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.

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.