Martha Elena Pat-Pech,1 Ricardo Francisco Gamboa-Guillermo,2 Sara Raquel Canul-Andrade1
1Jefatura de Enfermeras, Hospital General de Zona 1, Instituto Mexicano del Seguro Social; 2Investigador Independiente. Mérida, Yucatán, México
Correspondence: Martha Elena Pat-Pech
Received: November 10th 2014
Judged: January 26th 2015Accepted: March 16th 2015
Introduction: The treatment of chronic wounds and especially of pressure ulcers (PU) is one of the most complex and important health care problems in hospitals.
Objective: To evaluate the effectiveness of a treatment with and without a topical composition in the PU healing process.
Methodology: Intervention study, with a probability sampling stratified according to the stage of PU. Twelve patients were included, with a follow-up of 16 PU; eight were randomly selected for the study group with the application of the topical composition and eight for the control group. In both groups the healing process was done on the basis of a clinical practice guideline. The monitoring of the healing process in both groups was done weekly and the effectiveness of healing was calculated with the RESVECH V. 1.0 scale (Results expected from the assessment and healing progress of wounds). The statistical analysis was performed with SPSS, version 20.
Results: 75 % of the patients were men, who on average were 64.1 ± 11.1 years old. Of all the PU, 37 % were classified as stage II, 25 % as stage III and 38 % as stage IV. The effectiveness of the healing process was established in the days of intervention, the experimental group was 9.1 ± 3.3 and in the control group was 13 ± 2.3 days of intervention, the difference between the means was significant, t (14) = 2.155 , p < 0.05, two-tailed.
Conclusions: healing with topical composition is an alternative treatment for PU.
Keywords: Pressure ulcer; Topical administration; Wound healing
Pressure ulcers (PU) are a major challenge that professionals face in their clinical practice, since they constitute a great challenge for public health, both because of morbidity involved, and for their serious medical and economic implications.1
PU is an ischemic injury, localized to the skin and underlying tissues with loss of skin substance produced by prolonged pressure or friction between two hard surfaces, one from the patient and the other external to them.2
The reported prevalence worldwide according to WHO is 5 to 12% and 7% in Latin America.3 In Spain a total of 1596 patients were reported with PU, in whom the crude prevalence was 7.2% and the average prevalence (AP) was of 10.05%. The cost of treating pressure ulcers in that country is a significant outlay for the health system and society in general, because it approaches numbers exceeding 5% of annual health spending.4
In Mexico the Asociación Mexicana para el Cuidado Integral y Cicatrización de Heridas (AMCICHAC) reports that 17 of every 100 hospitalized patients suffers from pressure ulcers;5 in health institutions in 2011 a prevalence was reported ranging between 4.5 and 13%.6
Wound healing is a theme as old as human history. According to remains found in the valley of Dussel, Germany, Neanderthals in 60,000 BC used herbs for burns, and in the Smith papyrus dating back to 5000 BC, cures are described quite close to those used today.7
Healing can be defined as the technique that promotes tissue healing in any wound until its remission, which can have as its goal, used alone or with another treatment modality, complete wound closure or preparing of the wound for surgery as coadjuvant therapy.8,9
The First World War brought the use of cotton bandages soaked with paraffin or petroleum jelly, designed by the French surgeon G. Lumière.8 While these have been transformed by technology, the essence remains unchanged, i.e. it provides a surface with low adhesion rate. In an attempt to achieve a rational and effective treatment for chronic wounds, and with scientific and technological progress, treatment alternatives have appeared. Of these some are aggressive and others inaccessible to the common denominator of the population;10 most involve the use of topical preparations, allogeneic grafts, and surgery, plus pharmaceutical treatment with vasodilators, granulocyte colony-stimulating factor, angiogenic growth factors, hyperbaric oxygen, ultrasound , electrical stimulation, electromagnetic waves, lasers, infrared, and vacuum assisted closure devices.11
Frequently, for the healing of wounds, including pressure ulcers, gauzes impregnated with petrolatum, mineral oil, beeswax, and zinc oxide are used. In this investigation it is stated that by using a topical composition which contains the above elements, the properties of each are enhanced, as petrolatum and mineral oil possessing lubricating, moisturizing and emollient properties, creating a barrier on the skin; beeswax derived from honey has astringent, antioxidant, healing, anti-inflammatory and nutritious properties, and is rich in vitamin A; lanolin is a natural emollient wax, a mixture of cholesterol and fatty acids which is easily absorbed and maintains hydration; and zinc oxide has anti-inflammatory, anti-exudative, antiseptic, astringent, and decongestant properties, as well as also calming itching and burning. Putting them all together in an already established order12 creates a new topical composition with healing properties, resulting in clinical effects such as less pain, thermal insulation, and autolytic debridement. With this, the purpose was to evaluate the effectiveness of healing treatment with and without a topical composition in the healing of pressure ulcers.
Intervention study using stratified probability sampling, performed at the Hospital General Regional 1 (HGR1) of Instituto Mexicano del Seguro Social in Merida, Yucatan, Mexico. The study was submitted for evaluation by the Research Ethics Committee of the hospital; as such, it complies with the ethical provisions of the Declaration of Helsinki in its latest review and the amendment of Tokyo, Japan, from 2004. All patients were informed verbally and in writing of the healing procedures to be performed, their benefits and possible complications.
Twelve patients over 18 years hospitalized in Internal Medicine, Nephrology, General Surgery, Orthopedics and Neurosurgery in HGR1 were included, in which 16 pressure ulcers were monitored for four weeks. Eight were randomly selected for the intervention group and eight for the control group. They were stratified according to stage II, III and IV, and patients with stage IV pressure ulcers with fistulas or tunneling, or with vasopressor drugs in continuous infusion (dopamine, dobutamine and noradrenaline) were excluded. Patients who presented hemodynamic instability or support of vasopressor drugs in continuous infusion over 48 hours during the study were removed.
In both groups the PU healing process was done every 24 or 48 hours as recommended in the clinical practice guideline, Prevention and Treatment of Pressure Ulcers in Hospital.13 After healing, the patients in the experimental group were given gauze impregnated with a sufficient amount of topical composition (petrolatum, mineral oil, beeswax, and zinc oxide) to cover the entire surface of the ulcer. The healing process was estimated with the Wound healing index for chronic wounds (RESVECH V. 1.0. or Escala de resultados esperados de valoración y evolución de la cicatrización de las heridas crónicas),14 with scores whose magnitude and direction describe the conditions and development of lesions over time. This scale consists of nine items: 1) size of the lesion, 2) depth and affected tissues, 3) edges, 4) presence of periwound maceration 5) presence of tunneling, 6) type of tissue in wound bed, 7) exudate, 8) infection - inflammation (signs-biofilm) and 9) frequency of pain. Each of the items (subcategories) generates a total score, which ranges from 0 to 40 points; the higher the score, the greater the complexity of the lesion and vice versa.
Definition of measurement and variables
Here we establish the characteristics related to the evaluation of ulcers.14
It should be noted that the complication of the study was the blinding of patients and professionals regarding the intervention. With this consideration the data collection was in four stages: initiation (measure 0), 7 days (measure 1), 14 days (measure 2) and 21 days (measure 3). The evaluation and recording were done by a collaborator who did not know to which group each patient belonged. Data were analyzed using SPSS statistical program for Windows, version 20 in Spanish.
Average age of patients was 64.1 ± 11.1 years; 75% were male.
Most often pressure ulcers were located in sacrum and buttocks in 25% and 38%, respectively (Figure 1). Based on the classification of the Grupo Nacional para el Estudio y Asesoramiento de Úlceras por Presión (GNEAUPP)15 to 37% of patients were stage II, 25% stage III and 38% stage IV.
Figure 1. Anatomical location of pressure ulcers presented by patients
Regarding the assessment of the healing process with the RESVECH V. 1.0 scale, comparing the scores from measure 0 to measure 3 and based on the stage of the PU, favorable change was identified in 100% of both groups for the component of perilesional maceration. Only in the control group stage IV was at 50%. The presence of infection/inflammation (signs of biofilm) was found in stage IV pressure ulcers in both groups, with favorable development in 100% of the intervention group and 67% of the control group. 100% of patients in both groups reported pain at dressing change on the first healing; in subsequent healings, only 30% of control patients reported pain at dressing change and 50% of patients in the same group with PU stage III expressed pain at dressing change in subsequent healings (Table I).
|Table I. Evaluation of the healing process of pressure ulcers with RESVECH V. 1.0 scale|
|Measure 0||Measure 3||Measure 0||Measure 3||IG||CG|
|1. Dimension of the wound||II||2.7||2||3.3||3.3||26||0|
|2. Depth and affected tissues||II||1.6||1.3||1||-1.3||19||0|
|4 Periwound maceration||II||0.6||0.3||0||0||100||100|
|6. Type of tissue in wound bed||II||3||2.6||1.3||2.6||57||28|
|8 Infection, inflammation (signs of biofilm)||II||0||0||0||0||0||0|
|9. Frequency of pain||II||1||1||0||0.3||100||70|
|PU = pressure ulcer; IG = intervention group; CG = control group|
The effectiveness of the healing in the curing process was determined by the number of days of healing. The intervention group had a mean of 9.1 ± 3.3 days and for to the control group the mean was 13 ± 2.3 days; the difference between the means was significant: t (14) = 2.155, p < 0.05, two-tailed.
The lowest total of points was taken as Mann Whitney U value for N1 = 8, N2 = 8. The critical value was 13. This difference was significant: U = 5.2, p < 0.05, with 11.7 for the control group.
The percentage reduction in terms of surface and depth of pressure ulcers was 50% for PU stage I and 40% for PU stage IV of the intervention group in relation to the control group, which had 17% and 20% respectively (Figure 2).
Figure 2. Evaluation of healing process by stage of pressure ulcer
In reviewing literature, research was not found to speak of the components of topical composition. The use of honey, sucrose or zinc oxide used separately were mentioned. In this regard, Zamora Castro et al.16 in a descriptive study report the efficacy of sucrose. They mention that granulation tissue in stage III and IV appeared after seven days in all patients. In a meta-analysis study on the use of honey in chronic wounds, Cook17 found that this substance, being a harmless element, can bring many benefits for wound healing at a lower cost.
Healing with topical composition is an alternative treatment for pressure ulcers due to the healing properties of its elements. Its effectiveness in healing wounds is demonstrated. However, as this is the first investigation that is done, the results should be used with caution and further research is recommend in relation to cost and effectiveness.