Group 3. Treatment was then continued with polyurethane foam until healing, or for a maximum of 8 weeks. The dressings were changed 3 times a week. Sample size. Inclusion criteria. In addition, patients had to be available for treatment over 8 weeks.
Exclusion criteria. Patients who were less than years-old were excluded. Patients with fever, taking antibiotics at the time of the study, those with known allergies to the dressings being used in the study, or those with acute wounds, were excluded. Patients with terminal illness were also excluded. Eligible patients were assigned to the treatment group sequentially. The first 25 patients were assigned to group 1, the next 25 to group 2, and the final 25 patients to group 3.
Due to the distinct appearance of each product, it was not possible to blind the professionals or the patients. Statistical analysis was blinded as to the nature of each study group. Patient follow-up was carried out until the wounds completely healed or for a maximum period of 8 weeks. Time to resolve all signs of local infection not just a resolution of 1 or 2 signs , number of dressings required to resolve signs of local infection, Pressure Ulcer Scale for Healing PUSH index, time required to achieve total wound healing, occurrence of adverse effects in the wound bed or periwound skin related to the dressings maceration, erythema, excoriation, vesicles, pain when changing the dressing, edema, staining of the wound bed or periwound skin, and the remains of the dressing in the wound after removal.
Statistical analysis. Central trend measurements were used for the descriptive analysis mean, median, standard deviation, and minimum and maximum values of the quantitative variables, and for frequencies and proportions of qualitative variables.
The level of significance for the comparative analysis was 0. Kaplan-Meier plots were used to compare the probability of resolving infection and the probability of healing during the course of the study between treatment groups. Multivariate Cox regression models were used to test for a difference in the time to resolution of infection and the healing time between group 1 and groups 2 and 3, after adjusting for baseline factors that were found to be significantly associated with these outcomes.
Baseline characteristics. The distribution by wound type and treatment group is shown in Table 1. Baseline characteristics of the patients and wounds are shown in Table 2. Groups such as this, with fewer than 30 cases and no normal distribution, are better represented by the median, rather than the mean.
According to median values, the groups were comparable; the mean values were more sensitive to extreme values in the population. All wounds showed redness and heat. Resolution of clinical signs of infection. There was no evidence that any other baseline factors were associated with the time to resolution of infection. The time to resolution of infection and the number of dressing applications required are summarized in Table 3. The number of wounds in each of the first 4 weeks that no longer showed clinical signs of local infection is shown in Table 4.
The probability of resolving the clinical signs of infection during the course of the study are illustrated in Kaplan-Meier plots Figure 1. Complete healing. Patients in group 1 were nearly 3 times more likely to heal at any time during the study than patients in groups 2 or 3. Hazard ratios. The percentage of wounds healed during the study is shown in Figure 2.
The number of wounds healed from weeks 5—8 is shown in Table 5. The differences between treatment groups in the probability of healing during the course of the study are illustrated in the Kaplan-Meier plots Figure 3. Unwanted effects.
On exposure to high levels of wound exudate, Silvercel retained its shape and mechanical strength, and remained at the site of application. In contrast, Aquacel Ag formed a fluid semi-fibrous gel, with minimal mechanical integrity and variable retention at the wound site.
Silvercel was significantly more adherent to wound tissues than Aquacel Ag, but the level of trapped dressing debris, the frequency of ensuing foreign body reactions and the level of consequent wound-tissue disruption was lower, although not statistically, in the Silvercel-treated wounds.
This allows for intact removal. Specific indications, contraindications, warnings, precautions and safety information exist for KCI products and therapies. Third-degree burns Patients with a known sensitivity to alginates or silver To control heavy bleeding.
Precautions The dressing may adhere if used on very lightly exuding wounds. If the dressing is not easily removed, moisten it with sterile saline prior to removal. The dressing performance may be impaired by excess use of petrolatum-based ointments. Avoid contact with electrodes or conductive gels during electronic measurements, e. Clinical Solutions for Wound Management.
Diabetic Foot Ulcers. Venous Leg Ulcers. Pressure Ulcers. Directions for Use. Dressing Selection. Dressing Application. Cut using clean scissors or fold the dressing to fit the wound. Has a negative venous duplex. Is unable to tolerate 4 layer compression. Is unable to continue contact with the investigator for a period of at least two weeks.
Is unwilling or unable to comply with the study protocol. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. More Information. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.
Venous Ulcer Infection. Phase 4.
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