Application of a collagen matrix dressing on a neuropathic diabetic foot ulcer: a randomised control trial

Objective: Diabetic foot ulcers (DFU) are often hard-to-heal, despite standard care. With such a complicated healing process, any advanced wound care to aid healing is recommended. Chitosan/collagen composite hydrogel materials have the potential to promote the regenerative process. In this study, the efficacy of a new collagen matrix dressing including chitosan/collagen hydrogel was compared with a standard dressing of saline-moistened gauze for wound healing in patients with a hard-to-heal neuropathic DFU. Method: This is an open labelled, randomised clinical trial. After conventional therapy consisting of debridement, infection control and offloading, patients were randomly allocated to receive either a collagen matrix dressing (the study group, receiving Tebaderm manufacturer) or a saline-moistened gauze dressing (control group) for wound care. The reduction in DFU size and the number of patients with complete healing were measured throughout the treatment and in follow-up. Results: A total of 61 patients with a neuropathic DFU were recruited. Average percentage reduction in DFU size at four weeks was greater in the study group compared with the control group (54.5% versus 38.8%, respectively). Rate of complete healing rate at 20-weeks' follow-up was significantly better in the study group than the control group (60% versus 35.5%, respectively). Conclusion: The collagen matrix dressing used in this study accelerated the healing process of patients with a hard-to-heal DFU. Further research may suggest the used of this dressing to shorten the length of time to achieve complete healing.

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Outcomes More Than 2 Years After Meniscal Repair for Longitudinal Tears of the Lateral Meniscus Combined With Anterior Cruciate Ligament Reconstruction

The American Journal of Sports Medicine ◽

10.1177/0363546520981976 ◽

2021 ◽

pp. 036354652098197

Author(s):

Akira Tsujii ◽

Yasukazu Yonetani ◽

Kazutaka Kinugasa ◽

Tomohiko Matsuo ◽

Kenji Yoneda ◽

...

Keyword(s):

Ligament Reconstruction ◽

Cruciate Ligament ◽

Lateral Meniscus ◽

Complete Healing ◽

Control Group ◽

Study Group ◽

Meniscal Extrusion ◽

Second Look ◽

Anterior Cruciate

Background: Meniscal function after repair of longitudinal tears of the lateral meniscus (LM) with anterior cruciate ligament reconstruction (ACLR) has not been comprehensively investigated. Purpose: To evaluate not only the clinical outcomes and radiographic findings of patients who underwent repair of longitudinal tears of the LM combined with ACLR but also the healing status of the repaired meniscus and changes in chondral status with second-look arthroscopy. Study Design: Case series; Level of evidence, 4. Methods: Among 548 patients who underwent primary anatomic ACLR at our institution between 2010 and 2017, 39 who had concomitant longitudinal tears of the LM and underwent repair were studied. During follow-up for more than 2 years, all patients were evaluated clinically (pain, range of motion, swelling, and knee instability) and with imaging (plain radiograph and magnetic resonance imaging [MRI]), and compared with a matched control group (based on age, sex, body mass index, and follow-up period) without any concomitant injuries who underwent ACLR. Measurements on MRI were recorded preoperatively, immediately after surgery, and at final follow-up, and the change in the values over time was assessed. Of the 39 patients in each group, 24 were assessed by second-look arthroscopy with hardware removal 2 years postoperatively. Results: The mean follow-up times of the study and control group were at a mean of 42.4 and 45.4 months, respectively. There were no significant differences in clinical findings, lateral joint space narrowing on radiographs, and chondral status at the lateral compartment between groups, whereas lateral and posterior meniscal extrusion on MRI progressed significantly in the study group (0.43 ± 1.0 mm vs -0.29 ± 1.1 mm, P = .003; 1.9 ± 1.9 mm vs 0.14 ± 1.1 mm, P < .0001, respectively). Second-look arthroscopy revealed complete healing in 12 patients (50%), partial healing in 9 (37.5%), and failure in 3 (12.5%) in the study group, and no new tear in the control group. Conclusion: The clinical and imaging outcomes after repair of longitudinal tears of the LM combined with anatomic ACLR were successful and comparable with those after isolated ACLR without any other injuries at 42 months postoperatively, although meniscal extrusion showed progression on coronal/sagittal MRI. Based on the MRI findings and the result that only half of patients achieved complete healing, meniscal function could not be fully restored even after repair. Although degenerative changes were not apparent, longer-term follow-up is needed.

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Efficacy of low level infrared light therapy on wound healing in patients with chronic diabetic foot ulcers: a randomised control trial

International Surgery Journal ◽

10.18203/2349-2902.isj20191885 ◽

2019 ◽

Vol 6 (5) ◽

pp. 1650

Author(s):

Mimamaychet B. Sangma ◽

Selvakumaran Selvaraju ◽

Fremingston Marak ◽

Simon David Dasiah

Keyword(s):

Diabetes Mellitus ◽

Diabetic Foot ◽

Financial Burden ◽

Infrared Light ◽

Randomised Control Trial ◽

Foot Ulcers ◽

Control Group ◽

Study Group ◽

Diabetic Foot Ulcers ◽

Significant Difference

Background: A total of 52-patients with Type-2 Diabetes Mellitus having Meggitt-Wagner Grade-I of foot ulcers of at least more than 4-weeks duration, less than 6×6 cm, with negative culture were studied. Diabetic foot ulcers are serious complications of diabetes mellitus and are known to be resistant to conventional treatment. It also causes a significant cause of morbidity, mortality and financial burden. If the ulcer is left untreated they can create a severe complications. This study was designed to examine the effect of infrared radiation on the healing of diabetic foot ulcer.Methods: This clinical trial was performed on 52 patients with diabetic foot ulcer Wagner Grade-I. Patients were classified into 26 control and 26 study group. Electromagnetic radiations in the form of photons are delivered to the ulcer site by infrared light to stimulate healing.Results: Male preponderance was found with ratio of 2:1. Mean age of the patients was 58.82 years in control group and 52.44 years in study group. The mean HbA1C levels in the control groups were 7 (range 6.2-8.3%) and 7.2 (range 7-8%) in the study group, suggesting no biochemical differences between two groups. Mean reduction in the ulcer area was 375.30 mm in the control group and 893.56 mm in the study group and this differences between the two groups was statistically significant (p<0.010).Conclusions: It is shown that using infrared plus routine dressing is more effective than merely routine dressing in diabetic foot ulcers and there was a significant difference in reduction of ulcer size in study group.

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Role and effectiveness of complex and supervised rehabilitation on overall and hand function in systemic sclerosis patients—one-year follow-up study

Scientific Reports ◽

10.1038/s41598-021-94549-y ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Michał Waszczykowski ◽

Bożena Dziankowska-Bartkowiak ◽

Michał Podgórski ◽

Jarosław Fabiś ◽

Arleta Waszczykowska

Keyword(s):

Systemic Sclerosis ◽

Hand Function ◽

Exercise Program ◽

Rehabilitation Program ◽

Long Term Results ◽

Home Exercise ◽

Control Group ◽

Study Group

AbstractThe aim of this study was to estimate the long-term results of complex and supervised rehabilitation of the hands in systemic sclerosis (SSc) patients. Fifty-one patients were enrolled in this study: 27 patients (study group) were treated with a 4-week complex, supervised rehabilitation protocol. The control group of 24 patients was prescribed a home exercise program alone. Both groups were evaluated at baseline and after 1-, 3-, 6-, and 12-months of follow-up with the Disability of the Arm, Shoulder and Hand Questionnaire (DAHS) as the primary outcome, pain (VAS—visual analog scale), Cochin Hand Function Scale (CHFS), Health Assessment Questionnaire Disability Index (HAQ-DI), Scleroderma-HAQ (SHAQ), range of motion (d-FTP—delta finger to palm, Kapandji finger opposition test) and hand grip and pinch as the secondary outcomes. Only the study group showed significant improvements in the DASH, VAS, CHFS and SHAQ after 1, 3 and 6 months of follow-up (P = 0.0001). Additionally, moderate correlations between the DASH, CHFS and SHAQ (R = 0.7203; R = 0.6788; P = 0.0001) were found. Complex, supervised rehabilitation improves hand and overall function in SSc patients up to 6 months after the treatment but not in the long term. The regular repetition of this rehabilitation program should be recommended every 3–6 months to maintain better hand and overall function.

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318. Deferring Amputation in Diabetic Foot Osteomyelitis: Doing more Harm than Good?

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa439.514 ◽

2020 ◽

Vol 7 (Supplement_1) ◽

pp. S231-S232

Author(s):

Shiwei Zhou ◽

Brian M Schmidt ◽

Oryan Henig ◽

Keith S Kaye

Keyword(s):

Diabetic Foot ◽

Medical Management ◽

Wound Care ◽

Cohort Analysis ◽

Severity Of Illness ◽

Complete Healing ◽

Knee Amputation ◽

Management Group ◽

One Year ◽

Diabetic Foot Osteomyelitis

Abstract Background Diabetic foot osteomyelitis (DFO) is a leading cause of below knee amputation (BKA). Even when medical treatment is deemed unlikely to succeed, patients with DFO are often resistant to amputation. Methods An observational cohort analysis was done on patients with DFO at Michigan Medicine who were evaluated by podiatry and recommended BKA from Oct 2015 - Jun 2019. Primary outcome was mortality after BKA recommendation. Secondary outcomes were healing of affected limb, rate of BKA or above knee amputation (AKA) and total antibiotic days in the 6 months following. All intravenous antibiotics and oral courses of linezolid and fluoroquinolones were captured. Results Of 44 patients with DFO, 18 chose BKA, 26 chose medical management with wound care. Mean age of the cohort was 61, 68% male, 80% white with a median Charlson Comorbidity Index of 6 (IQR 4,7). The two groups were similar with regards to demographics and comorbid conditions. Those who chose medical management did so because their infection was non-life-threatening and they desired to avoid amputation. One-year mortality was greater in patients who were medically managed compared to those who had BKA (23.1% vs 0%, OR 11.7, 95% CI 0.6–222.9). Considering only the 33 patients who were followed for at least 2 years, 2-year mortality was also greater in the medically managed group compared to the BKA group (38.5% vs 5.6%, OR 10.6, 95% CI 1.2–92.7, Figure 1). Fewer patients in the medical management group had complete healing of their wound/stump compared to the BKA group (46.2% vs 88.9%, OR 9.3, 95% CI 1.8–49.1). In the medically managed group, 18 (69%) patients went on to require BKA or AKA at a median of 76.5 days compared to 2 (11%) in the BKA group who required AKA at 1 and 11 days following recommendation. Median antibiotic days were significantly greater in the medically managed group compared to the BKA group (55 IQR 42,78 vs 17 IQR 10,37, p=0.0017). Conclusion In this cohort of DFO patients where BKA was recommended, medical management was associated with increased mortality, poor healing of the affected limb, and excess antibiotic exposure compared to BKA. These findings are particularly notable as case mix and severity of illness were similar between the two groups. This study can be used to inform providers and patients in cases where BKA is recommended. Disclosures All Authors: No reported disclosures

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Autologous Peripheral Blood Mononuclear Cells for Limb Salvage in Diabetic Foot Patients with No-Option Critical Limb Ischemia

Journal of Clinical Medicine ◽

10.3390/jcm10102213 ◽

2021 ◽

Vol 10 (10) ◽

pp. 2213

Author(s):

Alessia Scatena ◽

Pasquale Petruzzi ◽

Filippo Maioli ◽

Francesca Lucaroni ◽

Cristina Ambrosone ◽

...

Keyword(s):

Peripheral Blood Mononuclear Cells ◽

Critical Limb Ischemia ◽

Diabetic Foot ◽

Peripheral Blood ◽

Mononuclear Cells ◽

Limb Ischemia ◽

Control Group ◽

Peripheral Blood Mononuclear ◽

Blood Mononuclear Cells

Peripheral blood mononuclear cells (PBMNCs) are reported to prevent major amputation and healing in no-option critical limb ischemia (NO-CLI). The aim of this study is to evaluate PBMNC treatment in comparison to standard treatment in NO-CLI patients with diabetic foot ulcers (DFUs). The study included 76 NO-CLI patients admitted to our centers because of CLI with DFUs. All patients were treated with the same standard care (control group), but 38 patients were also treated with autologous PBMNC implants. Major amputations, overall mortality, and number of healed patients were evaluated as the primary endpoint. Only 4 out 38 amputations (10.5%) were observed in the PBMNC group, while 15 out of 38 amputations (39.5%) were recorded in the control group (p = 0.0037). The Kaplan–Meier curves and the log-rank test results showed a significantly lower amputation rate in the PBMNCs group vs. the control group (p = 0.000). At two years follow-up, nearly 80% of the PBMNCs group was still alive vs. only 20% of the control group (p = 0.000). In the PBMNC group, 33 patients healed (86.6%) while only one patient healed in the control group (p = 0.000). PBMNCs showed a positive clinical outcome at two years follow-up in patients with DFUs and NO-CLI, significantly reducing the amputation rate and improving survival and wound healing. According to our study results, intramuscular and peri-lesional injection of autologous PBMNCs could prevent amputations in NO-CLI diabetic patients.

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1548. Association of bacterial colonization in ulcerative lesions of the diabetic foot together with the cicatrization process

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa439.1728 ◽

2020 ◽

Vol 7 (Supplement_1) ◽

pp. S773-S775

Author(s):

Alexander A Ozoria Loveras ◽

Jacques Paré Espinal ◽

David de luna ◽

Noemi Acevedo

Keyword(s):

Diabetic Foot ◽

Bacterial Colonization ◽

Healing Process ◽

Foot Ulcer ◽

Primary Source ◽

Diabetic Foot Ulcer ◽

Care Program ◽

Antimicrobial Treatment ◽

Control Group ◽

Experimental Group

Abstract Background In 2018, a review of the scientific literature identifed biofilm studies in the past 3 years. Wherein, the role of the biofilm in the progression of the diabetic foot ulcer with the presence of biofilm is reviewed. As a result, tissue sampling is more effective than transcure, Levin, and aspiration. A study in Cuba evaluate the effectiveness of a new proposal for antimicrobial treatment in patients with diabetic foot infection in 2017. The method used was a experimental type of two groups. The control group, was treated with the treatment scheme proposed in the Comprehensive Care Program for the patient with diabetic foot ulcer (PAIPUPD). Instead, the other experimental group was treated according to the scheme based on the local microbial map. They used a random distribution. Using the Wagner classification, there were patients classificate with a grade of W2 (13% of patients), W3 (66%) and W4 (12%). The most frequent germs found were Staphylococcus aureus, Escherichia coli and Enterobacter sp. The experimental group required less days with hospitalization. Methods This is an observational study of primary source with a non-probability sample with 58 patients. Adult patients diagnosed with type 2 diabetes mellitus, with diabetic foot, Wagner classification 1, 2 and 3, who attended the healing area of the Institute of Diabetes of Santiago were included. After identifying the colonized pathogen, its cicatrization process was evaluate for four weeks. Results Of the total sample, 12.07% belonged to Wagner 1, 43.1% to Wagner 2 and 44.83% to the Wagner 3 classification. In the case of the Wagner 3 group, S. aureus and Pseudomona aeruginosa were present in 6 cases. Despite the infectious processes detected by the culture, the patients showed a successful cicatrization process after four weeks of evaluation. Graph 1: Isolated Microorganism Vs Wagner’s Degree (n=60) Graph 2: Gram positive microorganism vs. healing process per week in patients with diabetic foot (n=22) Graph 3: Gram-negative microorganism vs. healing process (n=33) Conclusion During the four weeks of clinical evaluation, more than 88% of patients progressed positively to clinical recovery, regardless of the type of bacteria colonized and/or their resistance to antibiotics. Disclosures All Authors: No reported disclosures

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Effect of intravenous oxycodone on the physiologic responses to extubation following general anesthesia

BMC Anesthesiology ◽

10.1186/s12871-021-01350-5 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Menglu Jiang ◽

Jiawei Ji ◽

Xin Li ◽

Zhenqing Liu

Keyword(s):

Blood Pressure ◽

Heart Rate ◽

General Anesthesia ◽

Control Group ◽

Study Group ◽

Clinical Trial Registry ◽

Blood Oxygen Saturation ◽

Blood Concentrations ◽

Number Of Patients ◽

Blood Hormones

Abstract Background Endotracheal intubation and extubation may cause undesirable hemodynamic changes. Intravenous oxycodone has recently been introduced and used for relieving hemodynamic alterations in response to intubation, but there is insufficient information regarding its application in stabilizing hemodynamics during extubation in the patients emerging from general anesthesia. Methods One hundred patients, who had undergone assorted laparoscopic surgeries under general anesthesia, were randomly assigned to Control group (saline injection, 50 cases) and Study group (intravenous injection of 0.08 mg/kg oxycodone immediately after completion of the surgical procedure, 50 cases). Blood pressure, heart rate, blood oxygen saturation (SpO2) as well as blood concentrations of epinephrine, norepinephrine, and cortisol were recorded or measured immediately before extubation (T0), during extubation (T1), as well as one minute (T2), 5 min (T3), and 10 min after extubation (T4). In addition, coughing and restlessness, time of eye-opening, and duration from completing surgery to extubation as well as Ramsay Sedation Scale were analyzed. Results Blood pressure and heart rate as well as blood concentrations of epinephrine, norepinephrine, and cortisol were significantly higher in the Control group compared with the Study group at the time of extubation as well as 1, 5, and 10 min after extubation (P < 0.05). When the patients emerged from general anesthesia, 70 % of the Control group had cough, which was significantly higher than that of Study group (40 %, P < 0.05). Significantly higher number of patients manifested restlessness in the Control group before (40 %) and after extubation (20 %) compared with that in the Study group (20 and 2 %, respectively, P < 0.05). In addition, patients of Control group had lower Ramsay score at extubation (1.7 ± 0.7) as well as 30 min after extubation (2.4 ± 0.9) compared to that of the patients of Study group (2.2 ± 0.9, and 3.0 ± 0.8, respectively, P = 0.003 and 0.001). Conclusions Intravenous oxycodone attenuated alterations of hemodynamics and blood hormones associated with extubation during emergence from general anesthesia. Trial registration Chinese Clinical Trial Registry: ChiCTR2000040370 (registration date: 11-28-2020) “‘retrospectively registered”.

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Engineered Fat Graft Enhanced with Adipose-Derived Stromal Vascular Fraction Cells for Regenerative Medicine: Clinical, Histological and Instrumental Evaluation in Breast Reconstruction

Journal of Clinical Medicine ◽

10.3390/jcm8040504 ◽

2019 ◽

Vol 8 (4) ◽

pp. 504 ◽

Cited By ~ 31

Author(s):

Pietro Gentile ◽

Donato Casella ◽

Enza Palma ◽

Claudio Calabrese

Keyword(s):

Breast Reconstruction ◽

Preoperative Evaluation ◽

Three Dimensional ◽

Stromal Vascular Fraction ◽

Fat Graft ◽

Control Group ◽

Study Group ◽

Fat Tissue ◽

Calvarial Defects

The areas in which Stromal Vascular Fraction cells (SVFs) have been used include radiotherapy based tissue damage after mastectomy, breast augmentation, calvarial defects, Crohn’s fistulas, and damaged skeletal muscle. Currently, the authors present their experience using regenerative cell therapy in breast reconstruction. The goal of this study was to evaluate the safety and efficacy of the use of Engineered Fat Graft Enhanced with Adipose-derived Stromal Vascular Fraction cells (EF-e-A) in breast reconstruction. 121 patients that were affected by the outcomes of breast oncoplastic surgery were treated with EF-e-A, comparing the results with the control group (n = 50) treated with not enhanced fat graft (EF-ne-A). The preoperative evaluation included a complete clinical examination, a photographic assessment, biopsy, magnetic resonance (MRI) of the soft tissue, and ultrasound (US). Postoperative follow-up took place at two, seven, 15, 21, 36 weeks, and then annually. In 72.8% (n = 88) of breast reconstruction treated with EF-e-A, we observed a restoration of the breast contour and an increase of 12.8 mm in the three-dimensional volume after 12 weeks, which was only observed in 27.3% (n = 33) of patients in the control group that was treated with EF-ne-A. Transplanted fat tissue reabsorption was analyzed with instrumental MRI and US. Volumetric persistence in the study group was higher (70.8%) than that in the control group (41.4%) (p < 0.0001 vs. control group). The use of EF-e-A was safe and effective in this series of treated cases.

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Are patients willing to remove, and capable of removing, their own nonabsorbable sutures?

CJEM ◽

10.2310/8000.2012.120451 ◽

2012 ◽

Vol 14 (04) ◽

pp. 221-227 ◽

Cited By ~ 2

Author(s):

Peter Macdonald ◽

Nadia Primiani ◽

Adam Lund

Keyword(s):

Wound Care ◽

Intervention Group ◽

Comfort Level ◽

Patient Comfort ◽

Control Group ◽

Complication Rates ◽

Eligibility Criteria ◽

Telephone Contact ◽

Physician Visits

ABSTRACTObjectives:Providing patients with instructions and equipment regarding self-removal of nonabsorbable sutures could represent a new efficiency in emergency department (ED) practice. The primary outcome was to compare the proportion of patients successfully removing their own sutures when provided with suture removal instructions and equipment versus the standard advice and follow-up care. Secondary outcomes included complication rates, number of physician visits, and patient comfort level.Methods:This prospective, controlled, single-blinded, pseudorandomized trial enrolled consecutive ED patients who met the eligibility criteria (age > 19 years, simple lacerations, nonabsorbable sutures, immunocompetent). The study group was provided with wound care instructions, a suture removal kit, and instructions regarding suture self-removal. The control group received wound care instructions alone. Outcomes were assessed by telephone contact at least 14 days after suturing using a standardized questionnaire.Results:Overall, 183 patients were enrolled (93 in the intervention group; 90 in the control group). Significantly more patients performed suture self-removal in the intervention group (91.5%; 95% CI 85.4–97.5) compared to the control group (62.8%; 95% CI 52.1–73.6) (p< 0.001). Patients visited their physician less often in the intervention group (9.8%; 95% CI 3.3–16.2) compared to the control group (34.6%; 95% CI 24.1–45.2%) (p< 0.001). Complication rates were similar in both groups.Conclusion:Most patients are willing to remove, and capable of removing, their own sutures. Providing appropriate suture removal instructions and equipment to patients with simple lacerations in the ED appears to be both safe and acceptable.

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Abstract T MP103: Effect of Follow-up Phone Calls on 30-day Readmission Rates for Stroke Patients

Stroke ◽

10.1161/str.46.suppl_1.tmp103 ◽

2015 ◽

Vol 46 (suppl_1) ◽

Author(s):

Kelly Anderson

Keyword(s):

Intervention Group ◽

Signs And Symptoms ◽

Lifestyle Changes ◽

Phone Call ◽

Control Group ◽

Readmission Rates ◽

Convenience Sample ◽

Phone Calls ◽

Number Of Patients

Background and Purpose: Patients who are hospitalized for a stroke or TIA go home with a great deal of information about risk factors, medications, diet and exercise, signs and symptoms of stroke and follow-up care. This information may be difficult for the patient or caregiver to understand and can be overwhelming in the face of a new life-changing event. In addition, The Centers for Medicare and Medicaid Services will start publicly reporting 30-day readmission rates beginning in 2016. The purpose of this study is to determine if follow-up phone calls with a nurse help to reduce 30 day readmission rates for patients with stroke and TIA. Methods: This study utilized a convenience sample of adult patients who were admitted for ischemic stroke, ICH, SAH or TIA from March 2013 to February 2014. Patients in the intervention group participated in a phone call seven days after discharge to assess their compliance with medications, physician appointments and lifestyle changes. The proportion of readmissions between the groups was compared with Fisher’s exact test. Results: The total number of patients enrolled in the study was 586 and there were no significant differences in demographics between the control and intervention groups. Of the 533 patients in the control group, 54 (10%) of them were readmitted, including 11 patients readmitted for elective surgical procedures. Of the 52 patients in the intervention group, 3 (5.7%) of them were readmitted before the 7-day phone call. Of the 49 patients who participated in the 7-day phone call, none of them were readmitted ( p =0.0098). Conclusions: Patients who participate in a 7-day phone call appear to benefit and are less likely to be readmitted to the hospital. Other strategies may need to be considered for patients who are at higher risk, and thus more likely to be readmitted within seven days of discharge. In addition, some providers may wish to reconsider how they schedule elective procedures for secondary stroke prevention.

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