Local reactions to a chlorhexidine gluconate-impregnated antimicrobial dressing in very low birth weight infants.

Abstract

Chlorhexidine gluconate is a very effective antiseptic with a number of well-established medical applications.1-3 A chlorhexidine gluconate-impregnated opaque foam patch (BIOPATCH® antimicrobial dressing) which releases chlorhexidine gluconate over a period of several days has been developed as a central venous catheter dressing. The purpose of this report is to describe two types of local complications occurring during BIOPATCH® antimicrobial dressing use in sick neonates. Methods. Neonates with complications from the BIOPATCH® antimicrobial dressing were a part of an ongoing randomized multicenter trial designed to compare the efficacy of BIOPATCH® antimicrobial dressing to 10% povidoneiodine scrub at the time of central venous catheter insertion in neonates admitted to Level III nurseries. The trial has been under way since July, 1994, and involves six Level III nurseries. Infants randomized to BIOPATCH® antimicrobial dressing treatment have central venous catheter sites (surgically or percutaneously placed) scrubbed with isopropyl alcohol which is allowed to dry before catheter placement. A BIOPATCH® antimicrobial dressing (1.9-cm diameter for infants ≤1500 g, 2.5-cm diameter for infants >1500 g) is applied over the catheter site, and then both are covered with a clear polyurethan dressing (BIOCLUSIVE®; Johnson and Johnson Medical Inc., Arlington, TX). Dressings are changed every 7 days for as long as catheters remain in situ. If peripheral intravenous catheters are required they are inserted after an isopropyl alcohol and a 0.5% chlorhexidine gluconate (Hibistat®) scrub. Bedside nurses routinely examine all catheter sites daily for the presence of local reactions. A clinically significant local complication is defined by an area of skin breakdown with or without erythema at the site of the BIOPATCH® antimicrobial dressing or 10% povidone-iodine antisepsis. When possible infants who suffer a local complication are seen in follow-up clinic at 6 to 12 months corrected gestational age. Results. Nine of the first 300 infants enrolled in the trial developed local reactions. All reactions have occurred in BIOPATCH® antimicrobial dressing-treated infants. No local complications have occurred at peripheral intravenous catheter sites. In seven infants with exudative-type reactions, mean gestational age was 24.5 weeks (range, 22.5 to 26.5 weeks). Mean birth weight was 720 g (range, 560 to 880 g). The mean time to catheter placement was 4.7 days (range, 1 to 8 days). Local reactions were noted ≈4 days (range 2 to 6) after catheter placement. In all exudative cases the localized reaction had an erythematous base extending to the edge of the BIOPATCH® antimicrobial dressing. The erythematous base was partially to completely covered with an easily removable mucopurulent drainage (Fig. 1). Two of three sites cultured were sterile. One infant grew Klebsiella pneumoniae from the site and blood. The infant grew the same organism from a tracheal aspirate. Blood cultures done on the remaining infants were negative. Two reactions in 24-week gestational age infants weighing <800 g were nonexudative. In these reactions a ring of pale skin developed immediately beneath the BIOPATCH® antimicrobial dressing (Fig. 2). Capillary refill to gentle pressure was absent. The BIOPATCH® antimicrobial dressing was depressed into the skin surface by a tightly fitting BIOCLUSIVE™ dressing. Both sites were dry. All exudative-type local reactions healed well within 4 to 7 days in surviving infants. One infant with a nonexudative necrotic reaction expired before the lesion healed. The necrotic eschar in the second infant gradually contracted over 2 to 3 weeks and eventually peeled off, leaving new pink skin at the site of the former eschar. There was no contraction scar. One infant's catheter was removed because of catheter-related sepsis. A second infant's catheter was removed because of a suspected infection. The rest of the local complications healed with catheters in situ. To date two surviving infants have been seen in follow-up clinic. One infant was left with an area of depigmented skin surrounded by a ring of erythema and one infant had a very small (≤3 mm) scar where the local reaction had occurred. Since limiting study enrollment to babies who were >26 weeks gestational age, >800 g, and at least at 7 days of life at the time of catheter placement, 3 reactions have occurred in approximately 75 infants subsequently enrolled in the BIOPATCH® antimicrobial dressing arm of the study. These reactions have occurred in infants who had reached 27 to 28 weeks gestational age and had central venous catheters placed before 7 days of life. Discussion. Reduced thickness of the stratum corneum and diminished cohesion between dermal and epidermal layers4 in preterm infants increase low birth weight infants' susceptibility to skin damage, chemical burns or percutaneous absorption of drugs.5, 6 As the epidermal cell layer increases with advancing gestational and chronologic ages, the barrier properties and injury risk to the skin become similar to those of term neonates.4 Five of the local skin reactions noted in infants with BIOPATCH® antimicrobial dressings occurred in very premature (<26 weeks gestational age) young (≤7 days of age) neonates. Karwowska et al.7 reported similar reactions to the BIOPATCH® antimicrobial dressing. All of the reported infants weighed <1000 g. Even with the widespread use of chlorhexidine gluconate,8 few local allergic reactions or anaphylaxis have been reported following scrubbing with the antiseptic. No neonate has developed contact dermatitis after a chlorhexidine gluconate cleansing (Hibistat®) before peripheral intravenous catheter insertion. Factors other than chlorhexidine gluconate may be responsible for the reactions to the BIOPATCH® antimicrobial dressing. The occlusiveness of the BIOPATCH® antimicrobial dressing, continual skin exposure to chlorhexidine gluconate or local concentrations of chlorhexidine gluconate on the skin beneath the BIOPATCH® antimicrobial dressing may be reasons for the local reactions seen with the BIOPATCH® antimicrobial dressing and not to a 0.5% chlorhexidine gluconate (Hibistat®) scrub. We did not measure systemic chlorhexidine gluconate concentrations in infants with local reactions but speculate that absorption occurred through the macerated skin since others have reported absorption of both povidone-iodine and chlorhexidine gluconate through intact neonatal skin.9, 10 The second type of complication noted was a pressure necrosis at the site of the BIOPATCH® antimicrobial dressing. External pressure on capillary beds may limit capillary perfusion to the skin and lead to skin necrosis.11 In summary we report a series of very low birth weight infants who either developed a severe contact dermatitis to a dressing (BIOPATCH® antimicrobial dressing) used to dress central venous catheters or developed an area of pressure necrosis from improper use of the dressing during a randomized trial. The local reactions have prompted changes in enrollment criteria for the ongoing study. BIOPATCH® antimicrobial dressing use should be limited to chronologically (>7 days) and gestationally (>26 weeks) older infants. Pressure necrosis may occur with improper use of the BIOPATCH® antimicrobial dressing and steps should be taken to avoid excessive pressure over the surface area of the patch. Acknowledgments. We thank Dr. Nancy B. Esterly, Department of Pediatrics, Medical College of Wisconsin, for Figure 2. Photographs were taken after parental consent was obtained. Jeffery S. Garland, M.D., S.M.; Colleen P. Alex, R.N.; Christiann D. Mueller, R.N.C.; Lorna A. Cisler-Kahill, M.S., R.N. St. Joseph's Hospital (JSG, CPA) Sinai-Samaritan Medical Center (CDM, LACK) Milwaukee, WIFIG. 1: Contact dermatitis occurring in a 560-g, 22.5-week-gestation infant. The central venous catheter was placed on Day 1 of life and the reaction was noted on Day 3 of life. The photograph was taken on Day 4 of life.FIG. 2: Pressure necrosis occurring in a 710-g, 24-week-gestation infant. The pale area where capillary refill was absent corresponds to the former site of the BIOPATCH® antimicrobial dressing.