Prevention of 5-FU-induced health-threatening toxicity by pretherapeutic DPD deficiency screening: Medical and economic assessment of a multiparametric approach.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 3601-3601
Author(s):  
Michele Boisdron-Celle ◽  
Olivier Capitain ◽  
Jean-Philippe Metges ◽  
Roger Faroux ◽  
Christophe Borg ◽  
...  
Keyword(s):  
Economic Assessment ◽  
Economic Benefits ◽  
Severe Toxicity ◽  
Safe Treatment ◽  
Dose Adaptation ◽  
Screening Cost ◽  
Group A ◽  
Group B ◽  
Partial Deficiency ◽  
Deficiency Screening

3601 Background: While 5-FU is the foundation of many in GI oncology treatments, pts with DPD deficiency can experience early-onset severe (5%) even fatal (0.3%) toxicities. This study aimed to confirm the pharmaco-economic benefits of pre-therapeutic screening for DPD deficiency using a multiparametric approach in a multicenter prospective cohort study (NCT01547923). Methods: Two parallel cohorts of pts treated with 5-FU-based chemotherapy for colorectal carcinoma were compared: Group A: initial DPD deficiency screening; Group B: no evaluation. Enrollment was based on 5-FU administration guidelines of each institution. DPD deficiency screening combined genotyping and phenotyping (ODPM Tox) (1,2,3). The 2 groups were to be compared in terms of early 5-FU-induced toxicity grade, toxicity cost and DPD screening cost. The enrollment was to be immediately closed in the case of proven 5-FU-related toxic death. Results: 1,130 pts were included from 06/01/2008 to 07/31/2012. Group A: no severe toxicity despite 1 pt with complete deficiency (pt not treated with 5-FU), 20 pts with partial deficiency had safe PK-monitored 5-FU (ODPM Protocol) with only one hospitalization due to toxicity. Group B: One death due to complete DPD deficiency, confirmed retrospectively. Enrollment prematurely closed after experts’ unanimous decision citing ethical concerns. 21 pts with partial DPD deficiency. 5 reported toxicity-related hospitalizations. Data treatment is ongoing. Conclusions: One complete deficiency occurred in both groups: Group A pt had safe treatment whereas Group B pt died due to 5-FU toxicity. Pre-therapeutic DPD deficiency screening using this multi-parametric approach should be performed before 5-FU-based treatment and PK-guided dose adaptation allows for safe treatment of even partially DPD deficient patients. Clinical trial information: NCT01547923. [Table: see text]

Prevention of 5-FU-induced toxicities using pretherapeutic DPD deficiency screening: Medical and economic assessment of a multiparametric approach.

2013 ◽  
Vol 31 (4_suppl) ◽  
pp. 351-351 ◽  
Author(s):  
Michele Boisdron-Celle ◽  
Olivier Capitain ◽  
Roger Faroux ◽  
Christophe Borg ◽  
Jean-Philippe Metges ◽  
...  
Keyword(s):  
Economic Assessment ◽  
Patient Characteristics ◽  
Severe Toxicity ◽  
Screening Cost ◽  
Grade 5 ◽  
Group A ◽  
Multicenter Prospective Cohort Study ◽  
Group B ◽  
Partial Deficiency ◽  
Deficiency Screening

351 Background: 5-FU is the backbone of most chemotherapy regimens in GI oncology. Patients with DPD deficiency can experience early onset severe (5%) even fatal (0.3%) toxic side-effects. We decided to confirm the medical and economic interest of pre-therapeutic screening of DPD deficiency using a multiparametric approach in a multicenter prospective cohort study (Eudract n°2008-000026-39). Methods: Two parallel cohorts of patients treated with 5-FU-based chemotherapy for colorectal carcinoma were compared: Group A: initial DPD activity evaluation; Group B: no evaluation. Enrollment in either group was based on 5-FU administration guidelines at each institution. DPD deficiency screening combined genotyping and phenotyping (ODPM Tox) as well as other patient characteristics (1,2,3). The 2 groups were compared in terms of early 5-FU-induced toxicity grade, toxicity cost and DPD screening cost. The enrollment was to be immediately closed if 5-FU-induced toxic death occurred. Results: 1,130 patients were included from to 16/06/2008 to 07/31/2012. Group A: no severe toxicity despite 1 patient with complete deficiency (5-FU replaced by another TS inhibitor), 17 patients with partial deficiency safely received PK-monitored 5-FU (ODPM Protocol). Group B: 1 death: 65 y.o. patient, adjuvant FOLFOX 4, 5-FU-induced SAE at day 6: grade 4 febrile neutropenia, septicemia, diarrhoea, mucositis and secondary dehydration, renal failure, then death. 5-FU imputable Grade 5 SAE declared by investigator. Complete DPD deficiency retrospectively confirmed. The enrollment was prematurely closed after unanimous experts’ decision for ethical reasons. Data treatment is ongoing. Conclusions: One complete deficiency occurred in both groups: Group A patient had safe treatment whereas Group B patient died due to 5-FU grade 5 toxicity. DPD deficiency screening by a multiparametric approach (ODPM Tox) should be performed before 5-FU treatments. Clinical trial information: 2008-000026-39. [Table: see text]

Nab-paсlitaxel (Nab-P) in patients with metastatic breast cancer (mBC) with visceral crisis (VC): Efficacy and tolerability.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12589-e12589 ◽  
Author(s):  
Kristina A. Novoselova ◽  
Liubov Yu Vladimirova ◽  
Natalia A Abramova ◽  
Anna E Storozhakova ◽  
Irina L. Popova ◽  
...  
Keyword(s):  
Triple Negative ◽  
Objective Response ◽  
Metastatic Breast ◽  
Normal Liver ◽  
Severe Toxicity ◽  
Inclusion Criteria ◽  
Pharmacokinetics And Pharmacodynamics ◽  
Group A ◽  
P Application ◽  
Group B

e12589 Background: Better efficiency and safety of Nab-P is known to be due to the advantages of pharmacokinetics and pharmacodynamics of the drug. The fraction of unbound paclitaxel in plasma is 2.6-fold higher with Nab-P than with P. The purpose of the study was to assess efficacy and safety of Nab-P in ≥2nd lines of chemotherapy (CT) in patients (pts) with mBC with VC. Methods: Inclusion criteria: mBC with VC, ≥ 2 line of CT, HR+, HER2neu+ or triple negative type (TN), normal liver and renal function. Pts received Nab-P 260 mg/m2 q 21 days. Pts with Her2/Neu + received trastuzumab 6 mg/kg q 21 days. Results: 32 mBC pts, mean age 51.34 years (CI 35-76) were included. Among 32 pts Her2/Neu + had 5 (15.6%), TN – 9 (28.1%), HR+ 18(56.3%). 13(40.6%) pts received Nab-P as 2 line of CT, 13 (40.6%) pts, as 3-4 lines, 7(21.9%) as ≥5 lines. Pts were divided into 2 groups: group A - pts with VC 17(53.1%), group B - without VC 15(46.9%). Groups were comparable by age, number of previous CT lines, immunohistochemical types of BC. Group A had 2.47±0.32 CT lines (CV51.83%), including 8(47%) pts, who had received paclitaxel (P) in previous CT lines. Group B had on average 2±0.27 CT lines (CV53.03%). The objective response rate (ORR) was 37.5%(12 pts). In the group A ORR was 35.3% (6 pts). Out of 8 pts with VC, who had received P in previous lines, ORR was achieved in 3 pts (37.5%). In the group B ORR was 33.34%(5 pts). TTP was 6.8 mos (95% CI 6.1-13.7) for all pts, in the group A – 5.7 mos (95% CI 5.9-10.2), in the group B 6 mos (95% CI 6.5-13.7) (p = 0.046). Median 3-year OS of pts in group A was 18.9 mos (95% CI 4.3-22.4), in group B - 22.5 mos (95% CI 8.2-26.7) (p = 0.038). Toxicity did not differ significantly in pts in groups A and B and was manageable. Pts, who previously received P, had no new or severe toxicity. Conclusions: The data obtained confirms the possibility of Nab-P application in pts with VC. The use of Nab-P in pts treated with taxanes in previous lines is supposed for further study.

Carboplatin and paclitaxel versus cisplatin, paclitaxel and doxorubicin for frontline chemotherapy of advanced ovarian carcinoma (AOC): A Hellenic Cooperative Oncology Group Study

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 5074-5074
Author(s):  
G. Aravantinos ◽  
G. Fountzilas ◽  
H. P. Kalofonos ◽  
D. V. Skarlos ◽  
P. Kosmidis ◽  
...  
Keyword(s):  
Residual Disease ◽  
Randomized Study ◽  
Stage Iv ◽  
Figo Stage ◽  
Severe Toxicity ◽  
Treatment Groups ◽  
Stage Iv Disease ◽  
Group A ◽  
Intent To Treat ◽  
Group B

5074 Background: Carboplatin combined with paclitaxel are considered treatment of choice as initial chemotherapy for AOC. We compared this combination with a regimen combining cisplatin plus paclitaxel and doxorubicin. In the pre-taxane era the addition of doxorubicin to the cisplatin-based regimens appeared to improve survival. Therefore, there was a significant interest in assessing the role of a taxane/platinum/ anthracycline combination therapy in a randomized study. Methods: Patients with AOC after the initial cytoreductive surgery were stratified according to the FIGO stage and the presence of residual disease and randomized to either 6 courses of paclitaxel 175 mg/m2 as 3h infusion plus carboplatin 7AUC (group A) or paclitaxel at the same dose plus cisplatin 75 mg/m2 plus doxorubicin 40 mg/m2 and G-CSF (Lenograsim) 0.263 mg sc from day 7 to day 11 (group B). Primary endpoint was overall survival (OS). At alpha = 5%, 400 patients were required, to detect with power of 80%, a ±15% difference to a baseline survival rate of 50% at the 3-year time point. Results: Intent to treat analysis was performed on 432 patients (group A: 210, B: 222). The treatment groups were well balanced in terms of major patient and tumor characteristics. 70% of the patients had stage III and 23% stage IV disease. Significantly more patients developed febrile neutropenia in group B (p = 0.01). No other significant differences were observed in terms of severe toxicity and no difference was found between the two groups in complete and overall response rate. With a median follow up of 44 months, median survival was 37.2 months in group A and 45.2 months in group B (p = 0.33). Conclusions: Both regimens are well tolerated and effective as first line chemotherapy of AOC. Combination of cisplatin, paclitaxel and doxorubicin does not seem to improve survival as compared with the standard carboplatin/paclitaxel regimen. No significant financial relationships to disclose.

scholarly journals A Comparative Study between Single Dose of Ceftriaxone, Metronidazole and Gentamicine as a Prophylaxis versus Conventional Dose Antibiotic in Hysterectomy in BSMMU

2015 ◽  
Vol 32 (3) ◽  
pp. 149-152
Author(s):  
Salma Akter Munmun ◽  
Rowson Ara ◽  
Shiuly Chowdhury ◽  
Mst. Manjumun Ara Sarkar ◽  
Saleha Begum Chowdhury ◽  
...  
Keyword(s):  
Wound Infection ◽  
Abdominal Hysterectomy ◽  
Economic Benefits ◽  
Conventional Dose ◽  
Number Of Patients ◽  
Significant Difference ◽  
Group A ◽  
Group B ◽  
Clinical Records ◽  
Operative Wound

A prospective study was done in the Department of Obstetrics & Gynaecology, BSMMU, Dhaka from January 2006 to December 2006. Hundred cases were studied during this period. The patients admitted for hysterectomy operation were divided into group A and group B. In group A 50 patients received prophylactic injectable 1 gm ceftriaxone, 500 mg metronidazole and 80 mg gentamicine one hour before operation. In group B 50 patients received conventional antibiotic comprising ciprofloxacin for 7 days (both I.V and Oral), metronidazole for 5 days (both I.V and oral) and gentamicine for 3 days (I.V / I.M). After fulfilling the inclusion and exclusion criteria the patients were randomly assigned to receive either parenteral loading dose of 1 gm Ceftriaxone, 500 mg Metronidazole and 80 mg Gentamicine (Group-A) pre-operatively or conventional dose of antibiotic (Group- B). Relevant careful clinical records and data were kept on predesigned proforma. Incidence of post-operative complications, operative time and hospital stay were recorded for each patient. Data was analyzed using SPSS program with the consultation of the statistician. Because of nature of the analysis, only chi-squire(X2) test was applied. Most of the patients (64% in Group-A and 67% in Group-B) were from low socio-economic class. Significant number of patients were anaemic (Hb% between 50-55%) and duration of operation was within 60-89 minutes in most of the cases. There were 3(6%) post operative wound infection in Group- A and 2(4%) post operative wound infection in Group-B after abdominal hysterectomy. 1 patient of Group-A and 1 patient of Group-B developed wound infection after vaginal hysterectomy operation. So, there was no significant difference in post-operative wound infection between Group- A and Group-B. Length of post-operative hospital stays in both groups were within 5-9 days (Group-A 90% and Group- B 92%). The study demonstrates that there is no significant difference regarding surgical outcome between Group-A and Group-B. Moreover the patient of Group-A needs antibiotic cost only Tk. 220 and Group-B needs of about Tk. 640, so that it saves about Tk. 420 which supports the economic benefits for Group-A and cost effectiveness.J Bangladesh Coll Phys Surg 2014; 32: 149-152

Docetaxel, trastuzumab, pertuzumab versus trastuzumab emtansine as neoadjuvant treatment of HER2-positive breast cancer: Results from the Swedish PREDIX HER2 trial identifying a new potential de-escalation standard?

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 501-501 ◽  
Author(s):  
Jonas C. S. Bergh ◽  
Anne Andersson ◽  
Judith Bjohle ◽  
Ana Bosch ◽  
Lena Carlsson ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Neoadjuvant Therapy ◽  
Preoperative Treatment ◽  
Severe Toxicity ◽  
Trastuzumab Emtansine ◽  
Her2 Positive ◽  
Her2 Positive Breast Cancer ◽  
Group A ◽  
Group B ◽  
Positive Breast Cancer

501 Background: Neoadjuvant therapy produces high rates of pathological complete response (pCR) and is the standard of care in HER2 positive breast cancer; however, the optimal treatment regimen remains to be established. Methods: In this randomized phase II study patients ≥18 years with HER2 positive breast cancer > 20mm or verified lymph node metastases were randomized to 6 courses of docetaxel, trastuzumab and pertuzumab (DTP, group A) or trastuzumab emtansine (T-DM1, group B), q 21 days. The protocol allowed switch to the competing treatment upon lack of response or drug-related severe toxicity. Patients received postoperative epirubicin+cyclophosphamide, trastuzumab for a total of one year and endocrine therapy. Accrual was completed in October 2018 after randomization of 202 patients, data on pCR were available for 190 at the time for this abstract submission. Median age, 52 years (26-74), menopausal status, histological type and grade were well balanced between the treatment groups. 62.6% of the tumors were hormone receptor (HR) positive. Results: Primary endpoint was pathological objective response. 190 patients completed the protocol-specified preoperative treatment. pCR was achieved in 45.3% of patients, 46.4% in patients treated with DTP and 44.1% with T-DM1 (chi-sq., p = 0.75). In HR-positive tumors, pCR was obtained in 35.3% of patients, 35.9% in group A vs. 34.6% in group B (p = 0.87); in HR-negative tumors, the overall pCR rate was 62.0%, 66.7% in group A vs. 57.9% in group B (p = 0.45). Severe (grade 3/4) toxicity was reported at 68 occasions related to DTP, compared with 16 related to T-DM1, 26 vs. 3 caused by febrile neutropenia. Significantly better quality of life was reported by patients treated with T-DM1. Conclusions: Our data on TDM-1 demonstrates similar efficacy and less toxicity, in particular for patients with HER2 and HR positive cancers, being a potential new standard for neoadjuvant therapy. Clinical trial information: NCT02568839.

Pre-therapeutic dihydropyridimidine dehydrogenase (DPD) deficiency screening: Impact on fluoropyrimidine dose reduction at the second chemotherapy cycle and on early severe toxicity.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 3096-3096
Author(s):  
Côme De Metz ◽  
Benjamin Hennart ◽  
Marie-Cecile Le Deley ◽  
Pierre-Yves Cren ◽  
Christophe Desauw ◽  
...  
Keyword(s):  
Dose Reduction ◽  
Screening Method ◽  
Chemotherapy Cycle ◽  
Severe Toxicity ◽  
Dose Adaptation ◽  
Kappa Test ◽  
Grade 5 ◽  
Phenotype Analysis ◽  
Grade 3 ◽  
Deficiency Screening

3096 Background: DPD deficiency screening before fluoropyrimidine is a matter of debate. To avoid lethal toxicity, French authorities impose DPD screening before fluoropyrimidine-based chemotherapy by dosing uracilemia since April 2019. Methods: We have included all consecutive adult patients receiving 5-fluorouracil (5-FU) or capecitabin from April 2019 to January 2020 in 6 cancer centers. During the study period, different methods for screening had been applied: DPYD complete sequencing, phenotype (uracilemia and/or dihydrouracilemia/uracilemia ratio - UH2/U -) or both. All sceening tests were conducted in the same laboratory. Association between the method of DPD screening and fluoropyrimidine dose reduction at second chemotherapy cycle or on severe ≥grade 3 early toxicity (between first and second cycle) was evaluated using multivariate logistic regression. Concordance between genotype and phenotype for DPD deficiency was explored using Cohen Kappa test. Results: We included 597 patients, the median age was 63 (range, 55-77). The most prevalent cancers were digestive (68.3%), head and neck (19.4%) and breast (9.2%). 12.3% of patients received capecitabine and 87.3% received polychemotherapy. DPD deficiency screening was done for most of patients (n=519, 86.9%). DPD screening method consisted in full sequencing of DPYP (n=41; 7.9%), phenotype analysis (n=44, 8.5%) or both (n=424, 83.6%). We did not identify any complete DPD deficiency. Uracilemia was dosed for 467 patients, the median was 6.5 ng/mL and for 21 patients (4.5%) uracilemia was > 16 ng/mL and/or UH2/U <6, suggesting DPD deficiency. Severe early toxicities were observed for 82 patients (14%), with two patients presenting grade 5 toxicity. Overall DPD screening and method of DPD screening were not associated with fluoropyrimidine dose reduction at second cycle or early severe toxicity. In multivariate analysis, the only predictor for fluoropyrimidine reduction at second cycle (n = 125 patients) was polychemotherapy (OR=2.8; p=0.012). Kappa between uracilemia and UH2/U was 0.23 (poor concordance). Kappa between DPYP sequencing and uracilemia or UH2/U was 0.09 (very poor concordance). Conclusions: No DPD deficiency screening method was associated with dose adaptation at second cycle or early severe toxicity. The optimal strategy for DPD screening requires further clinical evaluation.

An ultrastructural study of sertoli cells in two geographically isolated populations of Aphanius dispar

1992 ◽  
Vol 50 (1) ◽  
pp. 548-549
Author(s):  
Taber A. Ba-Omar ◽  
Philip F. Prentis
Keyword(s):  
Ultrastructural Level ◽  
Uranyl Acetate ◽  
Freshwater Teleost ◽  
Isolated Populations ◽  
En Bloc ◽  
The North ◽  
Group A ◽  
Ultrathin Sections ◽  
Group B ◽  
Geographically Isolated

We have recently carried out a study of spermiogenic differentiation in two geographically isolated populations of Aphanius dispar (freshwater teleost), with a view to ascertaining variation at the ultrastructural level. The sampling areas were the Jebel Al Akhdar in the north (Group A) and the Dhofar region (Group B) in the south. Specimens from each group were collected, the testes removed, fixed in Karnovsky solution, post fixed in OsO, en bloc stained with uranyl acetate and then routinely processed to Agar 100 resin, semi and ultrathin sections were prepared for study.

Comparison of one-year prognosis of patients classified as chronic critical lower limb ischaemia according to TASC II or European consensus definition in the COPART cohort

VASA ◽  
2015 ◽  
Vol 44 (3) ◽  
pp. 0220-0228 ◽  
Author(s):  
Marion Vircoulon ◽  
Carine Boulon ◽  
Ileana Desormais ◽  
Philippe Lacroix ◽  
Victor Aboyans ◽  
...  
Keyword(s):  
Medical Treatment ◽  
Critical Limb Ischaemia ◽  
Limb Ischaemia ◽  
Medical Group ◽  
Consensus Definition ◽  
Transcutaneous Oxygen ◽  
European Consensus ◽  
Group A ◽  
One Year ◽  
Group B

Background: We compared one-year amputation and survival rates in patients fulfilling 1991 European consensus critical limb ischaemia (CLI) definition to those clas, sified as CLI by TASC II but not European consensus (EC) definition. Patients and methods: Patients were selected from the COPART cohort of hospitalized patients with peripheral occlusive arterial disease suffering from lower extremity rest pain or ulcer and who completed one-year follow-up. Ankle and toe systolic pressures and transcutaneous oxygen pressure were measured. The patients were classified into two groups: those who could benefit from revascularization and those who could not (medical group). Within these groups, patients were separated into those who had CLI according to the European consensus definition (EC + TASC II: group A if revascularization, group C if medical treatment) and those who had no CLI by the European definition but who had CLI according to the TASC II definition (TASC: group B if revascularization and D if medical treatment). Results: 471 patients were included in the study (236 in the surgical group, 235 in the medical group). There was no difference according to the CLI definition for survival or cardiovascular event-free survival. However, major amputations were more frequent in group A than in group B (25 vs 12 %, p = 0.046) and in group C than in group D (38 vs 20 %, p = 0.004). Conclusions: Major amputation is twice as frequent in patients with CLI according to the historical European consensus definition than in those classified to the TASC II definition but not the EC. Caution is required when comparing results of recent series to historical controls. The TASC II definition of CLI is too wide to compare patients from clinical trials so we suggest separating these patients into two different stages: permanent (TASC II but not EC definition) and critical ischaemia (TASC II and EC definition).

Absorbable suture material in carotid surgery

VASA ◽  
2015 ◽  
Vol 44 (6) ◽  
pp. 451-457 ◽  
Author(s):  
Vincenzo Gasbarro ◽  
Luca Traina ◽  
Francesco Mascoli ◽  
Vincenzo Coscia ◽  
Gianluca Buffone ◽  
...  
Keyword(s):  
Suture Material ◽  
Absorbable Suture ◽  
Paediatric Surgery ◽  
Carotid Surgery ◽  
Suture Materials ◽  
Absorbable Suture Material ◽  
Absorbable Sutures ◽  
Group A ◽  
Group B

Abstract. Background: Absorbable sutures are not generally accepted by most vascular surgeons for the fear of breakage of the suture line and the risk of aneurysmal formation, except in cases of paediatric surgery or in case of infections. Aim of this study is to provide evidence of safety and efficacy of the use of absorbable suture materials in carotid surgery. Patients and methods: In an 11 year period, 1126 patients (659 male [58.5 %], 467 female [41.5 %], median age 72) underwent carotid endarterectomy for carotid stenosis by either conventional with primary closure (cCEA) or eversion (eCEA) techniques. Patients were randomised into two groups according to the type of suture material used. In Group A, absorbable suture material (polyglycolic acid) was used and in Group B non-absorbable suture material (polypropylene) was used. Primary end-point was to compare severe restenosis and aneurysmal formation rates between the two groups of patients. For statistical analysis only cases with a minimum period of follow-up of 12 months were considered. Results: A total of 868 surgical procedures were considered for data analysis. Median follow-up was 6 years (range 1-10 years). The rate of postoperative complications was better for group A for both cCEA and eCEA procedures: 3.5 % and 2.0 % for group A, respectively, and 11.8 % and 12.9 % for group B, respectively. Conclusions: In carotid surgery, the use of absorbable suture material seems to be safe and effective and with a general lower complications rate compared to the use of non-absorbable materials.

Randomized trial of medical compression stockings versus two-layer short-stretch bandaging in the management of venous leg ulcers

Phlebologie ◽  
2009 ◽  
Vol 38 (04) ◽  
pp. 157-163 ◽  
Author(s):  
A. Franek ◽  
L. Brzezinska-Wcislo ◽  
E. Blaszczak ◽  
A. Polak ◽  
J. Taradaj
Keyword(s):  
Drug Therapy ◽  
Randomized Clinical Trials ◽  
Therapy Group ◽  
Long Term Results ◽  
Leg Ulcers ◽  
Compression Stockings ◽  
Venous Leg Ulcers ◽  
Group A ◽  
Group B ◽  
Medical Compression Stockings

SummaryA prospective randomized clinical trial was undertaken to compare a medical compression stockings with two-layer short-stretch bandaging in the management of venous leg ulcers. Study endpoints were number of completely healed wounds and the clinical parameters predicting the outcome. Patients, methods: Eighty patients with venous leg ulcers were included in this study, and ultimately allocated into two comparative groups. Group A consisted of 40 patients (25 women, 15 men). They were treated with the compression stockings (25–32 mmHg) and drug therapy. Group B consisted of 40 patients (22 women, 18 men). They were treated with the short-stretch bandages (30–40 mmHg) and drug therapy, administered identically as in group A. Results: Within two months the 15/40 (37.50%) patients in group A and 5/40 (12.50%) in group B were healed completely (p = 0.01). For patients with isolated superficial reflux, the healing rates at two months were 45.45% (10/22 healed) in group A and 18.18% (4/22 healed) in group B (p = 0.01). For patients with superficial plus deep reflux, the healing rates were 27.77% (5/18 healed) in group A and 5.55% (1/18 healed) in group B (p = 0.002). Comparison of relative change of the total surface area (61.55% in group A vs. 23.66% in group B), length (41.67% in group A vs. 27.99% in group B), width (46.16% in group A vs. 29.33% in group B), and volume (82.03% in group A vs. 40.01% in group B) demonstrated difference (p = 0.002 in all comparisons) in favour of group A. Conclusion: The medical compression stockings are extremely useful therapy in enhancement of venous leg ulcer healing (both for patients with superficial and for patients who had superficial plus deep reflux). Bandages are less effective (especially for patients with superficial plus deep reflux, where the efficiency compared to the stockings of applied compression appeared dramatically low). These findings require confirmation in other randomized clinical trials with long term results.

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