A clinical trial to study the efficacy of Negative Pressure Device (NPD) in traumatic paraplegia patients with bedsore.
- Conditions
- Health Condition 1: null- Bedsore
- Registration Number
- CTRI/2014/09/005014
- Lead Sponsor
- Council of Science Technology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 54
1.Sacral pressure sores in traumatic paraplegia patients with no signs of improvement and healing.
2.Stage III-IV pressure ulcer according to the National Pressure Ulcer Advisory Panel (NPUAP)
3.No clinical signs of active infection at the wound site and currently not on antibiotics.
4. Patients to give informed consent.
1.Candidate for surgery.
2.A wound with necrotic tissue unable to tolerate debridement.
3.Exposed blood vessels within the wound.
4.Chronic osteomyelitis (as determined by biopsy) or osteomyelitis that is not treatable by debridement and antibiotics.
5.Non-enteric or unexplored fistulae.
6.Wounds requiring homeostasis (i.e., that the flow of blood be stopped) for local bleeding.
7.Alternate etiology for non-healing.
8.Concomitant conditions that in the judgment of the investigator would make the subject inappropriate for entry to the study (e.g., malignancy in wound, malignancy less than 1-year disease free interval, previous or current irradiation, known immunodeficiency and/or major uncorrected medical disorders such as serious non-malignant disease, serious cardiovascular or pulmonary disease, lupus, inflammatory bowel disease, palliative care or sickle cell disease)
9.Poor nutritional status as determined by a Braden Scale Nutritional Assessment score of 2 or 1 with a serum albumin < 2.5 g/L and hemoglobin < 9.0 g/L.
10.Currently taking medication that may interfere with wound healing (e.g., oral systemic steroids, immunosuppressive drugs, unfractionated heparin infusion)
11.Women who are currently pregnant or are breast feeding; or women of child bearing potential who are not currently taking adequate birth control
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Time taken in healing (primary endpoint was a granulated wound or a wound ready for skin grafting or healing by secondary intention) <br/ ><br>2.Rate of reduction of wound surface area and wound depth <br/ ><br>3.Reduction in wound volume <br/ ><br>4.Time of becoming culture negative. <br/ ><br>5.Changes in levels of marker (MMP8). <br/ ><br>Timepoint: 3 Years <br/ ><br>
- Secondary Outcome Measures
Name Time Method Safety efficacy and cost effectiveness.Timepoint: 3 Years