Rytis Rimdeika

Reducing wound pain in venous leg ulcers with Biatain Ibu : A randomized, controlled double-blind clinical investigation on the performance and safety

Six out of 10 patients with chronic wounds suffer from persistent wound pain. A multinational and multicenter randomized double‐blind clinical investigation of 122 patients compared two moist wound healing dressings: a nonadhesive foam dressing with ibuprofen (62 patients randomized to Biatain Ibu Nonadhesive Coloplast A/S) and a nonadhesive foam without ibuprofen (60 patients to Biatain Non‐Adhesive—comparator). Patients were recruited from September 2005 to April 2006. The ibuprofen foam was considered successful if the pain relief on a five‐point Verbal Rating Scale was higher than the comparator without compromising safety including appropriate healing rate. Additional endpoints were change in persistent wound pain between dressing changes and pain at dressing change on days 1–5 (double blind) and days 43–47 (single blind). The primary response variable, persistent pain relief, was significantly higher in the ibuprofen‐foam group, as compared with the comparator on day 1–5, with a quick onset of action (p<0.05). Wound pain intensity was significantly reduced with the ibuprofen foam during day 1–5 with 40% from baseline, compared with 30% with the comparator (p<0.001). At day 43–47, the patients in the ibuprofen‐foam group had a significant (p<0.05) reemergence of persistent pain and pain at dressing change (p<0.05) when the active dressing was changed to the comparator. Wound healing was similar in the ibuprofen foam and comparator group. No difference in adverse events between the comparator and the ibuprofen foam with local sustained release of low‐dose ibuprofen was observed in this study. It was generally found that women reported less pain intensity than men, and pain intensity decreased with increasing age. In addition, pain intensity increased with initial pain intensity and increasing wound size. This study has demonstrated that the ibuprofen‐foam dressing provided pain relief and reduced pain intensity without compromising healing or other safety parameters.

Less pain with Biatain-Ibu: initial findings from a randomised, controlled, double-blind clinical investigation on painful venous leg ulcers

Six out of 10 patients with chronic wounds suffer from persistent wound pain. A multinational and multicentre, randomised, double‐blind clinical investigation of 122 patients compared two moist wound‐healing dressings, a non adhesive foam dressing with ibuprofen (62 patients randomised to Biatain‐Ibu non adhesive, Coloplast A/S) with a non adhesive foam without ibuprofen (60 to Biatain non adhesive).The ibuprofen‐foam was regarded successful, if the pain relief on a 5‐point verbal rating scale was higher than the comparator without compromising safety, including appropriate healing rate. Additional endpoints were change in persistent wound pain between dressing changes and pain at dressing change on days 1–5 and days 43–47. The primary response variable, persistent pain relief, was significantly higher in the ibuprofen‐foam group compared with the comparator on days 1–5, with a quick onset of action (P < 0·05). The patients in the ibuprofen‐foam group had a significant (P < 0·05) higher reduction in the persistent wound pain from baseline (40%) as the comparator (30%). Women reported less pain intensity than men, and pain intensity decreased with increasing age. In addition, pain intensity increased with increasing initial pain intensity and increasing wound size. Wound healing was similar in the ibuprofen‐foam group to that of the comparator group. No difference in adverse events between placebo and local sustained release of low‐dose ibuprofen was observed in this study. This study has demonstrated that the ibuprofen‐foam dressing provided pain relief and reduced pain intensity without compromising healing or other safety parameters. The full report of this study will be published in Wound Repair and Regeneration.

Measurement of melanoma thickness ― comparison of two methods: Ultrasound versus morphology

OBJECTIVE The aim of our study was to investigate the association between non-invasive ultrasound examination and morphologic test results in the measurement of cutaneous melanoma thickness influencing surgical treatment strategy. METHODS Our prospective clinical study has been conducted in the Clinic of Plastic and Reconstructive Surgery of Kaunas University of Medicine Hospital (KUMH) since January 2004 until October 2008. A total of 100 patients with a clear clinical diagnosis of stage I-II cutaneous melanoma were enrolled in this study. Melanoma depth was measured using a linear 14-MHz frequency ultrasound sensor (Toshiba Xario XG). Surgically removed fragments of skin-subcutaneous tissue were fixated using 10% formalin solution in the operating theatre, and sent to KUMH Clinic of Pathological Anatomy. The most informative sections were analysed for tumour thickness, according to Breslow, as well as tumour type, vascular and lymphatic invasion and dissemination. A comparative data analysis of melanoma thickness measured by ultrasound (T) preoperatively and histologically estimated cutaneous melanoma (CM) thickness according to Breslow (pT) using the Bland-Altman method was performed. RESULTS Higher mean difference of melanoma thickness (60 μm) between T and pT measurements was found when tumour thickness matched pT1 and pT2 categories. In cases of CM depth exceeding 2mm, mean difference of measurements between CM thickness determined by ultrasound and histological examination was lower (30 μm). Data regression analysis showed that correlation between T and pT measurements was lower when CM was thinner (1-2 mm) (Pearsons correlation coefficient, r: 0.283). In cases of thicker melanoma (>2 mm), strong and statistically significant (p<0.0001) correlation (r: 0.869) was observed. CONCLUSIONS Correlation between melanoma thickness measured using a linear 14-MHz frequency ultrasound sensor and histologically estimated melanoma thickness according to Breslow was lower if melanoma was thinner (1-2 mm). However, in cases of thicker melanoma (>2 mm), very strong correlation between measurements was observed.

The use of modern dressings in managing split-thickness skin graft donor sites: a single-centre randomised controlled trial

OBJECTIVE To identify the most appropriate, most suitable and most efficient dressing for split-thickness skin graft (STSG) donor sites. Comparing the wound healing rate, pain severity and duration, as well as the dressing change frequency in four randomised patient groups. METHODS A single-centre non-blinded randomised controlled trial was carried out during 2010-2014. All patients treated for skin defects/lesions (due to burns, trauma or ulcers) using STSG were included in the study. All patients were randomly allocated in four different donor site treatment groups; polyurethane (PU group, Mepilex); polyurethane with silicone membrane (PUSM group; Mepilex border,); transparent, breathable film (TBF group; Mepitel film) and cotton gauze dressings (CG group) using Excel 2007. We evaluated: wound healing time, pain severity and duration, the frequency of dressing change, donor site re-epithelialisation, donor site complications (signs of inflammation or infection). Patients were assessed on postoperative days: 1, 3, 6, 9, 12, 15, 18 and 21. RESULTS After random allocation of study participants the number of patients in each group were: PU group n=25; PUSM group n=24; TBF group n=24; CG group n=25. The groups were homogenous according to gender, age, main pathology, donor site area and wound size. The STSG donor site healing time varied from 9 to 21 days. The mean healing time in the CG group was 14.76 days, whereas in the PU, PUSM, and TBF group it was significantly shorter; 12.25 days, 11.63 days and 10 days, respectively. Patients in the TBF group demonstrated the most rapid healing time with 66.7% of STSG donor sites healed by postoperative day 9. The pain duration interval in modern dressing groups (PU, PUSM and TBF groups) was 0-9 days, whereas it was 6-18 day in the CS group. Pain intensity mean on postoperative day 1 was 2.21 in the PU group; 1.67 in the PUSM group; 1.46 in the TBF group and 3.04 in the CG group. The average pain duration in Group PU, PUSM, and TBF was 4.08 days; 2.5 days; 2.29 days, respectively. The average number of times each dressing was changed in each group was, 2.83 times in the PU group and PUSM group and 1.46 times in the TBF group. The CG dressing group were changed once when the donor site wound re-epithelialised. There was one patient in the PU group who experienced signs of infection, was treated accordingly and excluded from the study. CONCLUSION The fastest healing time was demonstrated by patients in the TBF group. The pain was not as severe and for a shorter period of time in modern dressing study groups. However, the pain was lightest and felt shortest in TBF dressing group. The modern dressings PU and PUSM had to be changed more frequently than TBF.

Sentinel lymph node biopsy for high-risk cutaneous squamous cell carcinoma: Analysis of recurrence-free survival.

BACKGROUND AND AIM Cutaneous squamous cell carcinoma (CSCC) is a malignant epithelial cell tumor. CSCC has a tendency to spread via lymphogenic pathway. Metastases are found in 2%-6% of cases. Prognosis of patients with CSCC is directly related to the morphology and localization of primary tumor. The aim of this study was to evaluate the recurrence-free survival of patients with CSCC after tumor excision and SLNB as well as to analyze morphologic CSCC features related to patient recurrence-free survival. MATERIALS AND MATERIALS A retrospective analysis of 51 patients with CSCC, who underwent surgical treatment between January 1, 2012, and December 31, 2014, in the Clinic of Plastic and Reconstructive Surgery, Hospital of the Lithuanian University of Health Sciences, was done. The diagnosis of CSCC was verified on a histological examination, and all patients had no clinical evidence of nodal or distant metastases on a physical examination or imaging studies. Sentinel lymph node biopsy (SLNB) was performed for low- and high-risk CSCC patients. RESULTS A total of 51 patients were enrolled into the study (34 women and 17 men). Total of 68 lymph nodes were removed during sentinel lymph node biopsy. No micrometastases were identified. Until April 1, 2015, no relapse event was documented. The mean time after operation was 27.5 months. During the follow-up period, no distant metastases were identified. CONCLUSIONS No patient who had no micrometastases in sentinel lymph nodes developed local and distant CSCC metastases during the follow-up period. Our report supports the concept that SLNB can be applied for CSCC. It is obvious that larger prospective studies with longer follow-up period are needed to establish the efficacy of SLNB and define the optimal treatment of occult nodal metastasis for CSCC.

Free musculocutaneous and muscle flaps for foot reconstruction: a clinical and gait analysis study

Abstract Between 1986 and 1995, 48 microvascular flaps (14 fasciocutaneous, 13 muscle, and 21 musculocutaneous) were performed on 47 patients with foot defects. The study group consisted of 19 patients who successfully underwent weightbearing surface reconstruction with free musculocutaneous flaps or muscle flaps with a skin graft. The groups were identified on the basis of the free flap used. Group 1: Latissimus dorsi musculocutaneous flaps (11 patients); group 2: Skin grafted muscle flaps (8 patients: latissimus dorsi - 6, gracilis - 1, rectus abdominis - 1). The follow-up period was 1–11 years (average: 8.3 years). Follow-up included documentation of foot pain, presence of ulceration, sensory recovery, the ability to wear normal shoes, and the need for a second operation. In group 1, debulking operations were necessary (8 patients, 72.7%). Debulking was not required in group 2. Ulceration occurred in four (36.4%) group 1 patients and in one (12.5%) group 2 patient. All patients had good deep pressure sensation. All the group 2 patients could wear normal shoes. Four (36.4%) of the group 1 patients had to wear special orthopedic shoes. The gait analysis consisted of two parts: footprint analysis with the Harris mat technique and plantogram of Parotec system by Kraemer. Foot analysis with the Harris mat showed that the pressure on the muscle flap is less than the pressure on the musculocutaneous flap. Gait analysis by the Parotec system showed that in patients with musculocutaneous flaps, static load distribution on the reconstructed bare foot is nearly normal, but dynamic load distribution is pathological. In patients with muscle flaps, both static and dynamic load distribution were close to normal.

Split-thickness skin grafting: early outcomes of a clinical trial using different graft thickness

OBJECTIVE In clinical practice, split-thickness skin graft (STSG) transplantation remains the gold standard for covering large skin defects. Currently, there is no consensus on the optimal thickness of skin grafts. The purpose of our study was to compare the early healing processes of recipient and donor wounds after STSG transplantation using grafts of different thickness. METHOD This prospective, randomised clinical trial included 84 patients that underwent STSG transplantation surgery for post-burn, post-traumatic or postoperative skin defects. Patients were randomised to receive a skin graft of either 0.2mm, 0.3mm or 0.4mm thickness. After skin transplantation, the wound healing parameters of both the recipient and donor wounds were evaluated after three days, one week, two weeks and one month. RESULTS The greatest mean epithelialisation scores and highest rate of complete wound epithelialisation were identified in the recipient and donor wounds of the 0.2mm transplant group, at all time points. When the recipient wound pain scores were evaluated, the greatest visual analogue scale (VAS) values were found in the 0.2mm transplant group. The opposite result was found for the donor wound, where the highest VAS scores were identified in the 0.4mm transplant group. There were no significant differences, at any follow-up period, when wound secretion, erythema, swelling, localised warmth and fluctuation were compared. CONCLUSION The early healing of recipient wounds after STSG transplantation with grafts of various thickness differed considerably, especially regarding wound epithelialisation and pain.

Importance of sentinel lymphatic node biopsy in detection of early micrometastases in patients with cutaneous squamous cell carcinoma

BACKGROUND Cutaneous squamous cell carcinoma (CSCC) is the second most common malignant skin cancer with a tendency to spread through the lymphogenic pathway. Metastases are found in 2-6% of cases. The aim of this study was to determine CSCC micrometastases when non-invasive examination methods do not detect them. METHOD A total of 88 patients were included in the study with clinically diagnosed, histologically confirmed CSCC and no distant or regional lymph node metastases detected during instrumental tests. The patients were grouped into low- and high-risk CSCC groups. They underwent one-stage surgery - radical tumour excision and sentinel lymph node/nodes biopsy (SLNB). Significance level of 0.05 was chosen for testing statistical hypotheses. RESULTS One hundred and fifty-three sentinel lymph nodes (SLNs) were detected and excised in 88 patients. Micrometastases were found in five SLNs of three patients with high-risk CSCC. The rate of micrometastases was 3.4%; however, in the high-risk group it was 6.5%. The mean diameter of CSCC with micrometastases in SLN was 5.6 ± 3.5 cm, and that without micrometastases was 1.5 ± 1.1 cm (p = 0.003). The depth of CSCC according to Breslow in the patients with detected micrometastases in SLN was 3.5 ± 1.2 mm, and that without detected micrometastases was 2.2 ± 1.4 mm (p = 0.047). Patients with micrometastases in sentinel lymphatic nodes underwent radical lymphadenectomy. There was neither recurrence of CSCC metastases in regional lymph nodes nor distant metastases during the research period detected. CONCLUSIONS In patients with CSCC the rate of micrometastases directly correlates with the depth and diameter of the tumour. In patients with high-risk CSCC the rate of micrometastases is 6.5%.

Laser Doppler imaging as a tool in the burn wound treatment protocol

Introduction The main treatment of burns is early excision of injured tissues. Aim To compare two different methods of examination of burned patients: clinical burn depth examination (CDE) and laser Doppler imaging (LDI). Material and methods A prospective randomized study of 57 burn patients treated in 2009–2011 was carried out. The burned patients were randomized into a CDE group and an LDI group. The CDE and LDI scan were performed 72 h after injury, with the second and third CDE and LDI scan on the 7th and 14th day after the burn. Age, sex, length of inpatient stay, cost of burn treatment, burn depth, cause and localization of the burns were analyzed between the two groups. Results Fifty-seven patients were treated during 2 years. Thirty-two patients were in the CDE group and 25 patients were in the LDI group. Most of the patients were male (45 male vs. 12 female, p < 0.001). The age was similar between the males and the females (female: 46.4 ±16.9 years vs. male: 46.3 ±12.5 years; p = 0.11). The mean length of stay in hospital was significantly higher in the CDE group (47 ±34.4 day vs. 25 ±10.8 day; p = 0.005). The mean cost of treatment of burned patients was significantly higher in the CDE group. Conclusions The length of stay and cost of treatment of burn patients depends upon early diagnosis of the deep burns and well-timed surgical treatment of burn wounds.

Epidemiologinė lyginamoji LSMU ligoninėje Kauno klinikose gydytų nudegimų analizė: 2003–2005 m. vs. 2013–2015 m.

Background and objectives Burns are one of the most severe traumas, which traumatism has been changing over the past decades, globally and nationally. In LUHS hospital Kaunas Clinics, a study which analyses latest tendencies in burn epidemiology has not been conducted. Since 1972 LUHS Hospital Burns Center has been a national severe burns treatment center, thus our study data well represents national burns statistics. Our study aim was to analyze and compare data about burned patients who were admitted to Plastic and Reconstructive Surgery and Burns Department in LUHS Hospital Kaunas Clinics during two periods: 2003–2005 and 2013–2015. Methods This was a retrospective study. Patients from two comparison groups: treated in 2003–2005 and during 2013–2015 were divided according to age, gender, burn etiology, depth, degree, localization, hospitalization stay, surgery time (early surgery 7 days post-burn). Overall data from 757 burn patients admitted during both periods were collected and analyzed. Results Statistically significantly more men suffered from burn injuries during the both periods (66.3% men, 33,7 % women). A statistically significant correlation between burn mechanism and gender was found: men are more likely to be burned by flame, women by scald. The most common burn localizations were arm, legs and head/neck/face regions. During the second period statistically significantly less arm, stomach/waist and leg region burns occurred. Flame was the most common burn cause in both periods. Hospital stay during the second period was statistically significantly shorter (26 days vs. 24 days). Deep burn number statistically significantly decreased from 79.5% to 49.3%. When comparing burn surgery tactics more early burn necrectomies (135 vs. 165) were performed sooner after the trauma (10 vs. 8 days) in 2013–2015. Conclusions Our study results match worldwide burns epidemiologic and treatment tendencies: less deep burns occur (79.5% during first period, 49.3% during the second period, p<0.05), hospital stay is getting shorter (26 days during first period and 24 days during the second, p<0.05). During 2013–2015, more early burn surgeries were performed (135 surgeries during first period vs. 165 during the second, p<0.05), which matches the worldwide burns treatment guideline. Epidemiological data from our study could help understand changes in burn injuries and to improve burn prevention strategies.