TRANSPARENT FILM DRESSING VS PRESSURE DRESSING AFTER PERCU- CORONARY ANGIOGRAPHY TANEOUS TRANSLUMINAL. Evidence-Based Practice in Critical Care

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1 Evidence-Based Practice in Critical Care TRANSPARENT FILM DRESSING VS PRESSURE DRESSING AFTER PERCU- TANEOUS TRANSLUMINAL CORONARY ANGIOGRAPHY By Stacie McIe, RN, BSN, Trisha Petitte, RN, BSN, Lori Pride, RN, BSN, Donna Leeper, RN, BSN, and C. Lynne Ostrow, RN, EdD C E 1.5 Hours tice to CE enrollees: A closed-book, multiple-choice examination following this article tests your under standing of the following objectives: 1. Examine how the researchers determined the best practice for dressing comfort and ease of percutaneous transluminal coronary angiography site assessment. 2. Describe how changes in practice were instituted through research. 3. Determine how this research process is important to your practice. To read this article and take the CE test online, visit and click CE Articles in This Issue. CE test fee for AACN members American Association of Critical-Care Nurses doi: /ajcc Background Pressure dressings have been used as the standard following sheath removal after percutaneous transluminal angioplasty in many institutions. Patients complain about discomfort while the dressing is in place, pain when the dressing is removed after discharge, and skin complications afterward. Many patients have experienced skin irritation where tape has been applied. Nurses have also described difficulty assessing the sheath insertion site in the groin when a pressure dressing is in place. Objectives To compare 3 different dressings with respect to effect on bleeding, discomfort voiced by patients, and ease of groin assessment in patients after percutaneous transluminal coronary angiography. Methods A total of 100 patients were randomly assigned to 1 of 3 groups: pressure dressing, transparent film dressing, or adhesive bandage. Outcome variables were bleeding, patient discomfort, and nurse-reported ease of observation of the groin site. Results bleeding occurred in patients with transparent film dressings or adhesive bandages. Patients rated these dressings significantly higher than they rated the pressure dressing. Because two-thirds of the sample had previously undergone percutaneous transluminal coronary angiography, they could compare their experience with the new dressing with previous experiences with pressure dressings. Nurses rated the ease of assessing the groin significantly higher for the transparent film and adhesive bandage dressings than for pressure dressings. Conclusions As a result of this study, a practice change was made hospital-wide: rather than a standard opaque pressure dressing, a transparent film dressing is used for all patients after removal of a femoral sheath. (American Journal of Critical Care. 2009;18:14-20) 14 AJCC AMERICAN JOURNAL OF CRITICAL CARE, January 2009, Volume 18,. 1

2 Angioplasty, which was first performed in 1997 for treatment of occluded coronary arteries, is now used in more than 1 million patients a year in the United States alone. 1 In 2005, a total of percutaneous transluminal coronary angioplasties (PTCAs) were performed. 2 Nurses at West Virginia University Hospitals, Ruby Memorial, Morgantown, West Virginia, noted that the type of dressing used after PTCA sheath removal was a cause for concern, especially for patients who had previously undergone PTCA and anticipated pain and discomfort with the dressing because of that experience. Many patients have memories of discomfort and skin irritation during and after dressing removal. Specifically, patients complaints include skin irritation, pain, pulling, rash, blisters, and skin burns after the dressing is removed (see Figure). The adult cardiac care units, the cardiac catheterization laboratory, and the interventional radiology department at West Virginia University Hospital all used pressure dressings as the standard after sheath removals. Nurses were concerned about their inability to visualize the sheath removal site to check for hematoma, bleeding, or groin complications at an early stage when the pressure dressing was in place. They also were concerned for patients who experienced discomfort, especially during and after dressing removal. Review of the Literature A literature search of PubMed and CINAHL was done by using the search terms dressings, bandages, and catheterization and/or angioplasty. We found only 2 studies 3,4 that addressed the issue of dressing type after cardiac catheterization. In the first study, 3 researchers compared traditional pressure dressing by means of an elastic adhesive bandage (Tensoplast) with use of a light transparent tape (Tegaderm). significant differences in bleeding were found between the 2 groups, but the group that used the light transparent tape reported significantly less pain and discomfort. In the second study, 4 a total of 739 patients undergoing diagnostic catheterization or interventional procedures were randomly assigned to receive About the Authors Stacie McIe, Trisha Petitte, Lori Pride, and Donna Leeper are nurses at West Virginia University Hospitals, Ruby Memorial Hospital, Morgantown, West Virginia. C. Lynne Ostrow is an associate professor at West Virginia University School of Nursing in Morgantown. Corresponding author: C. Lynne Ostrow, RN, EdD, PO Box 9260, West Virginia University School of Nursing, Morgantown, WV ( lostrow@hsc.wvu.edu). Figure Skin breakdown across the posterior part of the thigh where tape had been placed. either a pressure dressing or an adhesive bandage. The groups did not differ significantly in either incidence or size of bruising or hematoma, or in the frequency of complications such as pseudoaneurysm, embolism, or bleeding. The authors 4 concluded that the routine use of a pressure dressing was unnecessary, and, as a result, the institution where that study originated (in Edinburgh, Scotland) discontinued the use of pressure dressings for all cardiac catheterization patients. The goal of our study was to determine whether a change in the type of dressing used after PTCA reduced patients complaints and improved nurses abilities to assess the sheath insertion site after the procedure while maintaining patients safety. Three different types of dressings transparent film, Patients have discomfort and skin irritation during and after pressure dressing removal. AJCC AMERICAN JOURNAL OF CRITICAL CARE, January 2009, Volume 18,. 1 15

3 bleeding was noted when either transparent film dressings or adhesive bandages were used. Ease of groin assessment was greater with both the transparent film dressing and adhesive bandage compared with the pressure dressing. adhesive bandage, and pressure dressings were compared with respect to 3 outcomes: bleeding after PTCA, satisfaction of patients, and ease of nursing assessment of the sheath insertion site in the groin. The study was conducted at a tertiary care center (West Virginia University Hospital, a level I trauma center) that provides care for patients undergoing elective and emergent percutaneous coronary interventional procedures. The hypotheses for this study were as follows: Bleeding complications will not differ among the 3 dressing groups. Satisfaction will be higher among patients with a transparent film dressing and/or an adhesive bandage than in patients with a pressure dressing. Nurses will rate ease of assessment of the groin site higher in patients with a transparent film dressing and/or an adhesive bandage than in patients with a pressure dressing. The study was approved by the institutional review board at West Virginia University. Methods In this 3-arm experimental design, participants were randomly assigned to 1 of 3 dressing conditions: 1. Pressure dressing: 4-in (10-cm) Elastikon (Johnson & Johnson, New Brunswick, New Jersey) elastic tape (3 pieces, each about in [25-30 cm] long) secured over 1 box of 4 x 4-in (10 x 10-cm) gauze sponges 2. Transparent film dressing: Opsite IV3000 Standard (Smith & Nephew, London, England), a 4 x 5½in (10 x 14-cm) transparent dressing applied over one 2 x 2-in (5 x 5-cm) gauze sponge 3. Adhesive bandage: Flexible adhesive bandage (Kendall, Covidien, Mansville, Massachusetts), 4 x 2-in (10 x 5-cm) opaque dressing applied directly to the puncture site Patients who underwent PTCA with eptifibatide or bivalirudin and sheath sizes ranging from 6F to 8F were included in this study. Depending on the medication used, patients sheaths were removed by using either the manual technique or the FemoStop device (RADI Medical Systems, Uppsala, Sweden). Activated clotting times were measured hourly, and sheaths were removed when the activated clotting time was less than 150 seconds (eptifibatide) or less than 200 seconds (bivalirudin). Mechanical pressure was maintained with the FemoStop device for 60 minutes or manually for 30 minutes in each patient. The sheath removal site was then dressed with 1 of the 3 dressings as described earlier. All 60 nurses employed on the unit where patients were admitted after PTCA were trained to participate in the study. The nurses assessed the patients every 4 hours for complaints of discomfort in addition to the routine checking of vital signs and assessment of the groin site after sheath removal. The first assessment of the groin site was made when the dressing was applied, and additional assessments were done at 4-hour intervals after that. This frequency yielded a mean of 4.7 (SD, 0.06) assessments per patient. The nurses also recorded whether they were able to observe the groin site directly and rated the ease of assessment of the site for bleeding or hematoma formation on a scale of 1 (difficult to assess) to 5 (easy to assess). Patients complaints about the groin site were noted during these assessments. Patients were discharged 24 hours after admission and removed the dressing at home. A followup telephone call was made within 48 to 72 hours after discharge by a nurse investigator (T.P.). Patients were asked to rate how comfortable it was to remove the dressing and to rate the condition of the groin site when the dressing was removed. In order to rate the pain, patients were asked, On a scale of 1 (very comfortable) to 10 (painful), how comfortable was it for you to remove the dressing? The scale used was based on the Numeric Pain Scale 5 rating of 1 through 10 used in clinical nursing practice. Patients also were asked if they had ever had a catheterization with a pressure dressing before and, if so, how this experience compared with the previous one. Patients were given the opportunity to provide additional comments about the experience. The nurse surveyor recorded the comments verbatim. Data Analysis A power analysis was conducted on the basis of previous work 3 that showed a 40% difference between the 2 groups (pressure dressing vs light transparent tape) on the variable of discomfort. Thus, in order to test for that same difference among 3 groups, 26 patients per group would yield 80% power. The actual sample sizes of 32, 33, and 35 patients in each group yielded approximately 90% power. Descriptive statistics, χ 2 tests, and Kruskal- Wallis tests were used to analyze the data from the patients and nurses. 16 AJCC AMERICAN JOURNAL OF CRITICAL CARE, January 2009, Volume 18,. 1

4 Results A total of 213 patients gave consent to be in the study. Of these, 100 had catheterizations that showed stenosis and underwent angioplasty and stent placement. The study sample was 68% men and 32% women, with a mean age of 62 years (SD, 13.3). The majority (67%) of the sample had previously undergone catheterization. The mean number of previous catheterizations per patient was 2.06 (SD, 2.83). The type of drugs received during catheterizations, type of pressure applied after sheath removal, and activated clotting times are described in Table 1. ne of the demographic variables differed significantly among the 3 dressing groups. Patient Data The 100 patients were each hospitalized for a mean of approximately 24 hours if they had no complications. After sheath removal, the mean number of hours until discharge was 14.8 (SD, 2.3). Only 2 of the 100 patients, both in the pressure dressing group, had bleeding after sheath removal. One of these patients had a pseudoaneurysm. ne of the patients in the transparent film dressing or adhesive bandage groups had any bleeding. All but 4 patients were contacted via phone 48 to 72 hours after discharge. One patient had no memory of the event, so the final telephone sample was 95. A Kruskal-Wallis test was done to analyze for any differences in scores on the pain rating scale among the 3 dressing groups. Patients in the pressure dressing group rated the experience of removing the dressing as significantly more painful than did patients in either of the other 2 groups (Table 2). Patients in the transparent film group and patients in the adhesive bandage group did not differ significantly on this variable. At each assessment from when the sheath was removed to when the patient was discharged from the hospital, the nurses recorded what complaints (if any) the patients had about the groin site. A total of 26 patients (79%) with a pressure dressing had 1 or several complaints about the groin site (Table 3). Only 1 patient (3%) in the transparent dressing group had a complaint (skin irritation), and 3 patients (9%) in the adhesive bandage group had complaints. Patients were also asked how this experience compared with their last catheterization (67% of the sample had experienced at least 1 catheterization before this study, some at other institutions). Table 4 shows patients assessments of the transparent film dressing and adhesive bandage compared with prior pressure dressings. The patients qualitative comments were coded Table 1 Demographic data about the sample (N = 100) Characteristic Age, mean (SD), y. of previous catheterizations, mean (SD) Activated clotting time, mean (SD), s Sex, % of patients Male Female First catheterization, % of patients Drug during angioplasty, % of patients Bivalirudin Eptifibatide Abciximab Clopidogrel, % of patients Aspirin, % of patients Abciximab, % of patients Tirofiban, % of patients Eptifibatide, % of patients Type of pressure applied, % of patients Manual FemStop device as either positive or negative depending on the words they used to describe removal of the dressing. Almost half (48%) of the patients in the pressure dressing group had negative comments about the dressing. Conversely, 71% of the transparent film dressing group and 58% of the adhesive bandage group had positive comments. Many negative comments about previous pressure dressings were contained within 62 (13.3) 2.06 (2.83) 163 (20.5) a Percentages for some characteristics do not total 100 because of missing data. Table 2 Discomfort score by dressing Pressure (n = 33) Transparent film (n = 35) Adhesive bandage (n = 32) a Kruskal-Wallis test, χ 2 = 22.7, P <.001. Value a Mean score (SD) 6.0 (0.67) a 2.5 (0.44) 2.0 (0.43) AJCC AMERICAN JOURNAL OF CRITICAL CARE, January 2009, Volume 18,. 1 17

5 Table 3 Complaints about groin site while dressing in place Pressure (n = 33) Transparent film (n = 35) Adhesive bandage (n = 32) a Includes itching, skin irritation, burning, tightness, and pulling. Table 4 Comparison of present dressing with pressure dressing used in prior catheterization (n = 63) a,b Better Same Worse memory Pressure (n = 17) Transparent film (n = 25) Adhesive bandage (n = 21) 2 (12) 24 (96) 18 (86) Table 5 Examples of statements by patients Pressure Transparent film Adhesive bandage Complaints Pulling Discomfort Anticipating pain on removal of dressing Several complaints a Skin irritation Discomfort Anticipating pain Skin irritation/itching. (%) of responses 7 (41) 1 (4) 1 (5) a Percentages may not total 100 because of rounding. b χ 2 = 42.15, P <.001. Statement. (%) of patients 5 (15) 3 (9) 4 (12) 14 (42) 6 (35) 2 (12) 2 (9) Rated as an 8 (10 being most painful) because of pain associated with pulling hair off back of leg when removing dressing. Red welts all over his leg when tape came off. Adhesive turned to glue in shower and became part of my body. Liked transparent dressing much better than pressure dressing in past. Dressing came off so easily. Dressing this time was much better than pressure dressing. Pressure dressing pulled skin off with last catheterization. Lots better than when they used all tape in the hospital! Much better than pressure dressing by far. Dressing was a godsend. This dressing so much better. It was much easier to walk around. Would recommend to anyone having a catheterization. More than better. Fantastic. Comes off easily. You don t have to pull, tug, scream, and yell. Recommend the adhesive bandage to anyone. If he has another catheterization, will not have that big dressing again. the praise for the transparent film dressing or adhesive bandage. Examples of actual statements by the patients are presented in Table 5. Nurse Data Each patient had a minimum of 2 nurses (range, 2-4 nurses) who made the assessments every 4 hours. The nurses were asked to respond to 2 questions at each of these assessments. The first question was, Were you able to directly observe the groin site? Percentages of yes and no responses were averaged for all nurses over all observation points. For the transparent film dressing, 97% of the nurses answered yes, as did 59% for the adhesive bandage group (Table 6). Only 15% of the nurses in the pressure dressing group said that they were able to observe the groin site directly. These percentages are significantly different from one another (χ 2 = 47.2, P <.001). The nurses also were asked to rate the ease of assessment of the groin for bleeding or hematoma once the dressing was in place. The scores were again averaged for all nurses across all observation points to determine a mean score for ease of observation. Because the data were ordinal, a Kruskal-Wallis test was done to assess for any differences in ease of observation among the 3 types of dressings. A significant χ 2 of 67.1 (P <.001) was found (Table 7). Mann-Whitney tests were used to determine which pairs differed; differences were significant (P <.001) between the pressure dressing and the transparent film and between the pressure dressing and the adhesive bandage, but not between the transparent film and the adhesive bandage. Ease of observation of the groin was rated significantly lower for the pressure dressing group than for either the transparent film or adhesive bandage groups. Discussion bleeding complications occurred in patients in the transparent film or adhesive bandage dressing groups, but 2 complications occurred in the pressure dressing group. Patients rated the transparent film and adhesive bandage dressings as more comfortable while the dressings were in place, easier to remove at home, and better than their last experience with cardiac catheterization when they had had a pressure dressing. Patients gave graphic comments about the discomfort felt while the pressure dressing was in place and after it was removed. In contrast, patients in the transparent film and adhesive bandage groups had positive comments about the dressings and viewed them much more favorably than pressure dressings. Although ratings for the transparent film dressing were slightly higher 18 AJCC AMERICAN JOURNAL OF CRITICAL CARE, January 2009, Volume 18,. 1

6 than ratings for the adhesive bandage, those differences were not statistically significant. Nurses reported that they could directly observe the groin for bleeding in patients with transparent film or adhesive bandage dressings. Nurses also reported greater ease in assessing the groin site with both the transparent film dressing and the adhesive bandage as opposed to the pressure dressing. Our findings in relation to bleeding and increased comfort of patients are similar to results reported for both earlier studies 3,4 in which different types of dressings were examined. As a result of this research study, a practice change has been instituted at West Virginia University Hospital. We discussed the study results with all persons in the institution who had an interest in the issue, including interventional radiologists, cardiology physicians, and vascular surgeons, and changes in policy and procedure were reviewed and agreed on. Nursing staff were oriented to the policy change via posters and staff meetings. The new policy was developed after review of the latest procedure guidelines from the American Association of Critical-Care Nurses 6 and incorporates the changes as a result of our research. The results of our study, which had a 3-arm experimental design, revealed significantly greater satisfaction among patients after cardiac catheterization when the sheath insertion site in the groin was dressed with either a transparent dressing or a simple adhesive bandage rather than the standard pressure dressing. Nurses also reported improved ease of assessment of the groin site in patients with the transparent film or adhesive bandage dressings. Our report illustrates the process of making a practice change based on research evidence. The clinical problem of dissatisfaction among patients was identified by the nurses caring for patients after PTCA and spurred a review of literature on the topic. Consultation with a faculty member in the school of nursing enabled us to plan and implement this study. The result has been an institution-wide change in practice. t only have patients benefited from this change, but members of the nursing staff have increased their knowledge, skills, and commitment to evidence-based nursing practice. FINANCIAL DISCLOSURES ne reported. Table 6 Ability to directly observe the groin site Pressure (n = 33) Transparent film (n = 35) Adhesive bandage (n = 32) a χ 2 = 47.2, P < (%) of dressings a 5 (15) 34 (97) 19 (59) Table 7 Ease of assessment of groin for bleeding or hematoma Mean score a SD Pressure Transparent film Adhesive bandage REFERENCES 1. National Heart, Lung, and Blood Institute. Diseases and conditions index: what is coronary angioplasty? WhatIs.html. Published July Accessed October 2, American Heart Association. Angioplasty and cardiac revascularization statistics. presenter.jhtml?identifier=4439. Accessed October 5, Boonbaichaiyapruck S, Hutayanon P, Chanthanamatta P, et al. Groin dressing after cardiac catheterization. Comparison among light dressing with thin transparent tape (Tegaderm) and conventional tight/pressure dressing and elastic adhesive bandage (Tensoplast). J Med Assoc Thai. 2001;84(12): Robb C, McLean S. Using pressure dressings after femoral artery sheath removal. Prof Nurse. 2000;15(6): McCaffery M, Pasero C. Pain: Clinical Manual. St Louis, MO: Elsevier Saunders; American Association of Critical-Care Nurses. Procedure Manual for Critical Care. 5th ed. St Louis, MO: Elsevier Saunders; To purchase electronic or print reprints, contact The InnoVision Group, 101 Columbia, Aliso Viejo, CA Phone, (800) or (949) (ext 532); fax, (949) ; , reprints@aacn.org. 28 (85) 13 (41) a χ 2 = 67.1, P <.001. Significant difference between pressure dressing and the other 2 types of dressings. eletters w that you ve read the article, create or contribute to an online discussion on this topic. Visit and click Respond to This Article in either the full-text or PDF view of the article. AJCC AMERICAN JOURNAL OF CRITICAL CARE, January 2009, Volume 18,. 1 19

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