Fractional CO2laser treatment of caesarean section scars-A randomized controlled split-scar trial with long term follow-up assessment

2016 ◽  
Vol 49 (2) ◽  
pp. 189-197 ◽  
Author(s):  
Katrine E. Karmisholt ◽  
Elisabeth H. Taudorf ◽  
Camilla B. Wulff ◽  
Emily Wenande ◽  
Peter A. Philipsen ◽  
...  
Keyword(s):  
Caesarean Section ◽  
Randomized Controlled ◽  
Long Term Follow Up

scholarly journals OT-Equator® Attachments Comparison for Retaining an Early Loaded Implant Overdenture on Two or Three Implants: 1 Year RCT Preliminary Data

2021 ◽  
Vol 11 (18) ◽  
pp. 8601
Author(s):  
Marco Tallarico ◽  
Gabriele Cervino ◽  
Marco Montanari ◽  
Roberto Scrascia ◽  
Emiliano Ferrari ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Survival Rates ◽  
Marginal Bone Loss ◽  
Patient Centered ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Long Term Follow Up ◽  
Implant Overdenture

The purpose of this multicenter randomized controlled trial was to compare the clinical, radiographic, and patient-centered outcomes of early loaded mandibular overdentures deliberately placed on two or three implants. The outcomes were: implant and prosthesis success and survival rates; biological and technical complications; marginal bone loss; patient satisfaction; and periodontal parameters. The results showed no differences between the groups in any of the outcomes analyzed. With the limitations of the present study, and looking at long-term follow-up, the gold standard of prosthetic rehabilitations with attachments, in agreement with the scientific community, should prefer two non-splinted implants.

T1 Top Line Results of the DETECT Enzymatic Debridement Multicenter Randomized Controlled Trial

2020 ◽  
Vol 41 (Supplement_1) ◽  
pp. S1-S1
Author(s):  
William L Hickerson ◽  
Jeremy Goverman ◽  
Sigrid A Blome-Eberwein ◽  
Adam Singer ◽  
Lucy Wibbenmeyer
Keyword(s):  
Median Time ◽  
Wound Closure ◽  
The United States ◽  
Acute Stage ◽  
Phase Iii ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Long Term Follow Up

Abstract Introduction Bromelain Based Debridement (BBD) of deep burns is approved for use in Europe, Argentina, Russia, South Korea, Peru and Israel. In the United States it is an investigational product and currently there are 2 multicenter RCTs (DETECT – adults, CIDS – children). Patient enrollment in the DETECT adult trial has been completed. The aim of this abstract is to present the acute stage top line results of the DETECT trial. Methods 175 adult patients suffering from deep burns were included in a phase III multicenter, multinational, randomized, controlled, assessor blinded trial. Patients were randomized to 3 arms – BBD, Standard of Care (SOC), or Gel vehicle (Placebo control) in a 3:3:1 ratio (75 BBD, 75 SOC, 25 Gel). The primary endpoint was the incidence of complete eschar removal (BBD vs Gel). Additional acute stage endpoints included the time to complete eschar removal, incidence of surgical eschar removal and eschar removal associated blood loss.Time to complete wound closure (BBD vs SOC) was assessed as a safety endpoint. Following the acute stage, a long-term follow up period of 2 years is being conducted. Results Patient demographics and wound baseline characteristics were comparable across study arms.The incidence of complete eschar removal was significantly higher for BBD vs Gel patients (93.3% vs 4%, p< 0.0001). The incidence of surgical eschar removal was significantly lower for BBD vs SOC patients (4% vs 72%, p< 0.0001). The median time to complete eschar removal was significantly shorter for BBD vs SOC patients (1 day vs 3.8 days, p< 0.0001). Calculated eschar removal associated blood loss was significantly lower for BBD vs SOC patients (14ml vs 815ml, p< 0.0001). The median time to complete wound closure was similar for BBD and SOC patients (27 and 28 days). The overall safety profile of BBD treated patients was good and consistent with the safety data known from previous studies.The results of the long term follow up period are not yet available. Conclusions The acute stage results of this robust phase III RCT demonstrate the safety and efficacy of BBD and are in line with previous trial results. Applicability of Research to Practice The results of this trial may help pave the way for US approval of BBD.

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