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| The clinical contributions of Hollister Wound Care dressings have been demonstrated in numerous clinical studies carried out in collaboration with medical and nursing professionals. Clinical trials have demonstrated the efficacy of this new, lipidocolloid technology (now called TRIACT Technology) in the management of a variety of acute and chronic wounds. The following is a bibliography of select papers published about Restore Dressings. |
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| Restore Contact Layer Dressing in Pediatric Patients |
Letouze A, Voinchet V, Hoecht B, Muenter KC, Vives F, Bohbot S. (2004) Using a new lipidocolloid dressing in paediatric wounds: results of French and German clinical studies. J Wound Care, 13 (6): 221-225.  (2343 KB - 9 pages) |
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| This multicenter prospective evaluation enrolled 100 pediatric patients between the ages of one and 12 years. Seventy-seven of the children had burn injuries. Use of Urgotul® (distributed in the United States as Restore® Contact Layer Dressing by Hollister Wound Care LLC) was assessed by physicians, nurses and the children, themselves. Nearly 475 dressing changes were noted using the lipidocolloid technology, consisting of a novel polyester mesh, hydrocolloid particles, and petrolatum molecules (known in the United States as TRIACT™ Technology). Primary outcome was defined as the number of children with full wound healing (100% re-epithelialization). In France, 86% of the 55 patients with burns healed within four weeks and in Germany all 22 patients healed within the evaluation period. Mean time between dressing changes was about three days in the two studies. Not only did the new dressings prove to be efficacious but the physicians, nurses and
children found the dressings easy to use, conformable and non-adherent. During dressing changes, pain was considered totally absent in 60% (burns) and 74% (other wounds) in France and 57% (burns) and 97% (other wounds) in Germany. |
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| Restore Silver Foam Dressing used with Compression Dressings in Colonized Venous Ulcers |
| Lazareth I, Ourabah Z, Senet P, Cartier H, Sauvadet A, Bohbot S. (2007). Evaluation of a new silver foam dressing in patients with critically colonized venous leg ulcers. J Wound Care, 16(3), 129-132. (2647 KB - 7 pages) |
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| This was a non-randomized evaluation conducted at 12 sites covering 470 care episodes and representing 1250 cumulated days of treatment. Forty-five adult patients with leg ulcers (predominantly venous leg ulcers) were treated with UrgoCell Silver (known in the United States as Restore Non-Adherent Foam Dressing with Silver and TRIACT Technology). Clinical signs of colonization decreased from 3.6 ± 0.7 at baseline to 1.2 ± 1.2 (p<0.001) at the end of the four week evaluation. At base line, all patients had previously been treated with paraffin gauze, foam dressings or alginate dressings. Seventy-three percent of study ulcers were considered to be stagnant or deteriorating at the initiation of the study. Despite the relatively poor prognosis of these wounds, 78% of the investigating physicians considered that the wounds had improved or healed after four weeks of treatment. Heavy exudate was present in 89% (40) of the patients at baseline and by end of week four only about half (19)
of these difficult to control cases were still producing a high degree of exudate. The Restore Non-Adherent Foam Dressing with Silver and TRIACT Technology was well tolerated when used with various types of compression therapy and had a favorable impact on patients with leg ulcers and clinical signs of colonization |
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| Safety and Efficacy |
| Meaume S, Senet P, Dumas R, Carsin H, Pannier M, Bohbot S. (2002) Urgotul®: a novel non-adherent lipidocolloid dressing. Br J Nurs 11 (16) (TVN Suppl): S42-3, S46-50. (3093 KB - 9 pages) |
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| A report of the multi-center, non-controlled clinical study conducted in France to confirm the efficacy and safety of Urgotul® (distributed in the U.S. as Restore Contact Layer from Hollister Wound Care LLC). The study sample consisted of 92 patients aged 18 or older with acute and chronic wounds treated with the study dressing. Subjects were followed up to four weeks or until their wounds had healed. Outcome measures included wound healing rate, ease of dressing application and removal, and tolerance of the dressing. |
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| Restore Contact Layer and Treatment of Acute and Chronic Wounds |
| Benbow M, Iosson G. (2004) A clinical evaluation of Urgotul® to treat acute and chronic wounds. Br J Nurs 13 (2):105 – 109. (2351 KB - 7 pages) |
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| This single-center, descriptive study was conducted in the UK to evaluate the use of Urgotul® (distributed in the U.S. as Restore Contact Layer from Hollister Wound Care LLC), in the management of acute and chronic wounds. 22 adult subjects were treated with the study dressing and followed weekly for up to four weeks. Variables measured included ease of application, conformability and non-adherence, absence of trauma, pain, and bleeding on removal. |
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| Restore Contact Layer and Treatment of Venous Leg Ulcers |
| Meaume S, Ourabah Z, Cartier H, Granel-Brocard F, Combemale P, Bressieux JM, Bohbot S. (2005). Evaluation of a lipidocolloid wound dressing in the local management of leg ulcers. Journal of Wound Care, 14(7), 329-334. (2144 KB - 9 pages) |
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| A report of a multi-center randomized clinical study conducted in France to compare the outcomes of subjects using Urgotul® (distributed in the U.S. as Restore Contact Layer from Hollister Wound Care LLC) to a comparison group using a hydrocolloid dressing for the treatment of venous leg ulcers. 91 subjects (47 Urgotul, 44 hydrocolloid) were followed weekly for eight weeks. All subjects had compression wraps applied over the study dressing. Wound closure, dressing tolerance, and acceptability of the dressing were evaluated. |
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| Enhancing Patient Comfort through Dressing Selection |
| Meaume S, Téot L, Lazareth I, Martini J, Bohbot S. (2004). The importance of pain reduction through dressing selection in routine wound management: the MAPP study. J Wound Care, 13(10), 409-413. (2140 KB - 9 pages) |
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| Report of a study to determine the prevalence of painful wounds in outpatients; 5,850 patients, 656 doctors and 707 nurses participated. The prevalence of moderate to severe pain during dressing change was similar in acute and chronic wounds: 85% and 92% respectively. 1,879 subjects were subsequently treated with Urgotul® (distributed in the U.S. as Restore Contact Layer from Hollister Wound Care LLC) to evaluate the effect of the study dressing on patient comfort. |
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| Using Restore Contact Layer with Multi-Layer Compression Therapy |
| Smith J, Barrett S, Hayes W, Kirby P, Walsh S, Gittins E, Whitehurst F, Cooper R. (2004). Evaluation of Urgotul® plus K- Four compression for venous leg ulcers. B J Nurs. 13(6) (TVN Suppl): S20 – 28. |
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| Report of the use of Urgotul® (distributed in the U.S. as Restore Contact Layer from Hollister Wound Care LLC) with multi-layer compression wraps in 36 subjects. Treatment continued for 12 weeks or until the ulcers healed. Outcome measures included pain on dressing change, adherence to the wound bed and condition of the surrounding skin. |
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| Restore Contact Layer and Traumatic Digital Wounds |
| Ma KK, Chan MF, Pang SMC. (2006). The effectiveness of using a lipidocolloid dressing for patient with traumatic digital wounds. Clin Nurs Res, 15(2): 119-134. |
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| This randomized controlled trial of 28 subjects (16 study dressing; 12 controls) compared the effect of Urgotul®(distributed in the U.S. as Restore Contact Layer by Hollister Wound Care LLC), to a daily gauze dressing change. Subjects had full-thickness acute wounds to the finger. Variables measured included healing time and time to wound closure. Wounds closed significantly faster (12.1 days vs. 16.8 days) using Restore Contact Layer (p=.024). |
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| Use of Negative Pressure Wound Therapy with Restore Contact Layer |
| Téot L, Lambert L, Ourabah Z, Bey E, Steenman C, Wierzbiecka E, Malikov S, Charles JP, Vives F, Bohbot S. (2006). Use of topical negative pressure with a lipidocolloid dressing: results of a clinical evaluation. J Wound Care, 15(8), 355-358. (2067 KB - 7 pages) |
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| Reports the results of a prospective, multi-center, non-comparative trial of the use of Urgotul® (distributed in the U.S. as Restore Contact Layer from Hollister Wound Care LLC), in conjunction with negative pressure wound therapy. 66 subjects were included (42 acute wounds and 24 chronic wounds) and followed for an average of 17 days. Dressing changes were deemed entirely painless in 52% of cases (compared with 18% at baseline). Dressing removal was considered "very easy" or "easy" in 94% of cases and adherence to the wound was recorded as "absent" in 88%. |
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| Leg Ulcers and Restore Foam Dressing |
| Fays S, Schmutz JL, Vin F, Thirion V, Sigal-Grinberg M, Ingen-Housz-Oro S, Estève E, Sauvadet A, Bohbot S. Leg ulcers and the UrgoCell non-adhesive wound dressing. Br. J. Nursing 14 (11) 2005 Tissue Viability Supplement, S15-S20. (2883 KB - 9 pages) |
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| Reports the results of a multi-center trial of 43 subjects with venous leg ulcers, treated with Restore Foam Dressing for up to six weeks. Study endpoints were reduction in wound surface area, dressing tolerance, and ease of use. The surface area of treated leg ulcers was reduced by a mean of 38% after six weeks of treatment. Very good tolerance of dressing changes was noted by patients (96.4% reported no pain or only minor pain). During the 521 local care operations, dressings were rated "very easy" or "easy to use" by 98.6% or the nurses. |
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