Controlled human infection trials: Legitimacy and conditions of implementation in France.

This round table is the result of an observation. The observation being that controlled human infection clinical trials (also called "infectious challenge" trials or "Controlled Human Infection Models", "CHIM") recommended or even encouraged in the context of vaccine developments in particular, are not carried out in France. However, there are no formal prohibitions within regulations or ethical principles, which point to the prior assessment of risks and benefits for individuals and for society. The participants in this Round Table thus wished to examine, through the prism of their respective disciplines, the scientific and medical relevance of conducting such trials in France and, if possible, to imagine the conditions under which they would be carried out, thus resulting in recommendations on (1) the advisability of their conduct in France (2), the conditions under which they would be implemented in terms of logistics and regulations, and (3) their social acceptability. The recommendations on which the participants of the Round Table came to an agreement are presented as the analysis progresses.

Prolonged stay at an acute-care hospital in Israel among older adults awaiting transfer to post-acute care: retrospective study on risk factors and consequences.

BACKGROUND: Older adults frequently experience deconditioning following acute illnesses and require discharge from acute-care facilities to post-acute care facilities, which are limited. Our study aimed to explore predictors and outcomes associated with elongated length of stay (LOS) among older adults awaiting discharge to skilled nursing facility (SNF). METHODS: Retrospective cohort study was conducted at Shamir Medical Center, Israel, among adults (> 65 years) eligible for SNF. ROC curve analysis was used to determine prolonged LOS based on the risk to fall. Logistic and Cox regressions were used to analyze predictors and outcomes. RESULTS: Among 659 older adults awaiting transfer to SNF, 127 patients (24% among survivors of the index hospitalization) had prolonged LOS (> 12 days). The median age of patients was 82 years and 51% were females. The independent predictors for prolonged LOS were lower Norton index, higher MUST score, and admission from home. Prolonged LOS was independently associated with hospital-acquired infections, device related infections, and acquisitions of multidrug-resistant organisms. CONCLUSION: Prolonged LOS among older adults, awaiting transfer to SNF, should be suspected among non-institutionalized older adults with lower nutritional status and higher risk of pressure ulcers. The burden associated with establishing additional SNF beds, must be outweighed vs. the substantial infectious complications among awaiting older adults.

Temperature-controlled laser-soldering system and its clinical application for bonding skin incisions.

Laser tissue soldering is a method of repairing incisions. It involves the application of a biological solder to the approximated edges of the incision and heating it with a laser beam. A pilot clinical study was carried out on 10 patients who underwent laparoscopic cholecystectomy. Of the four abdominal incisions in each patient, two were sutured and two were laser soldered. Cicatrization, esthetical appearance, degree of pain, and pruritus in the incisions were examined on postoperative days 1, 7, and 30. The soldered wounds were watertight and healed well, with no discharge from these wounds or infection. The total closure time was equal in both methods, but the net soldering time was much shorter than suturing. There was no difference between the two types of wound closure with respect to the pain and pruritus on a follow-up of one month. Esthetically, the soldered incisions were estimated as good as the sutured ones. The present study confirmed that temperature-controlled laser soldering of human skin incisions is clinically feasible, and the results obtained were at least equivalent to those of standard suturing.

Immediate tight sealing of skin incisions using an innovative temperature-controlled laser soldering device: in vivo study in porcine skin.

BACKGROUND: A feedback temperature-controlled laser soldering system (TCLS) was used for bonding skin incisions on the backs of pigs. The study was aimed: 1) to characterize the optimal soldering parameters, and 2) to compare the immediate and long-term wound healing outcomes with other wound closure modalities. MATERIALS AND METHODS: A TCLS was used to bond the approximated wound margins of skin incisions on porcine backs. The reparative outcomes were evaluated macroscopically, microscopically, and immunohistochemically. RESULTS: The optimal soldering temperature was found to be 65 degrees C and the operating time was significantly shorter than with suturing. The immediate tight sealing of the wound by the TCLS contributed to rapid, high quality wound healing in comparison to Dermabond or Histoacryl cyanoacrylate glues or standard suturing. CONCLUSIONS: TCLS of incisions in porcine skin has numerous advantages, including rapid procedure and high quality reparative outcomes, over the common standard wound closure procedures. Further studies with a variety of skin lesions are needed before advocating this technique for clinical use.

Closure of skin incisions in rabbits by laser soldering: I: Wound healing pattern.

BACKGROUND AND OBJECTIVES: Temperature-controlled tissue laser soldering is an innovative sutureless technique awaiting only solid experimental data to become the gold-standard surgical procedure for incision closure. The goals of the current study were: (1) to define the optimal laser soldering conditions, (2) to explore the immediate skin reparative healing events after sealing the wound, and (3) to determine the long-term trajectory of skin wound healing. STUDY DESIGN/MATERIALS AND METHODS: Skin incisions were generated over rabbit dorsa and were closed using different wound-closure interventions, in three groups: (a) closure, using a temperature-controlled infrared fiberoptic CO2 laser system, employing 47% bovine serum albumin as a solder; (b) wound closure by cyanoacrylate glues; and (c) wound closure by sutures. The reparative outcomes were evaluated macroscopically and microscopically, employing semi-quantitative grading indices. RESULTS: Laser soldering of incisions at T = 65 degrees C emerged as the optimal method achieving immediate wound sealing. This in turn induced accelerated reparative events characterized by a reduced inflammatory reaction, followed by minimal scarring and leading to a fine quality healing. CONCLUSIONS: Temperature-controlled laser soldering offers an accelerated wound reparative process with numerous advantages over the conventional methods. Further investigations may reveal additional benefits in the spectrum of advantages that this innovative surgical technology has to offer. This can introduce new scientific insight that will pave the way for clinical use.

Closure of skin incisions in rabbits by laser soldering II: Tensile strength.

BACKGROUND AND OBJECTIVES: The basic characteristic property of wound closure is the immediate and long-term tensile strength (LTS). The objective of the current study was to compare tissue laser soldering to other available methods (i.e., cyanoacrylate glues and sutures) in the performance and outcome of wound closure and reparative healing process, with an emphasis on the immediate and LTS. STUDY DESIGN/MATERIALS AND METHODS: The animals were divided into three groups according to the type and details of the closure procedure. Group A: laser treatments at different temperatures were compared to sutured incisions, emphasizing the LTS after 10 days. Group B: laser soldering at 65 +/- 5 degrees C was compared to chemical glues (i.e., Histoacryl and Dermabond), emphasizing the immediate tensile strength (ITS). Group C: LTS of laser soldered incisions was compared to that of sutured incisions at various time intervals emphasizing LTS (3, 7, 14, 28 days). RESULTS: Group A: LTS at 60 degrees C exhibited the highest values (0.48 MPa). Group B: no ITS difference was detected between laser soldering and chemical glues. Group C: soldered incisions at 65 degrees C exhibited higher LTS (1.81 MPa) than that of sutured incisions (1.08 MPa) (P < 0.043). CONCLUSIONS: Temperature-controlled laser soldering at 65 degrees C provided sufficient ITS and higher bonding LTS values compared with sutures, resulting in better wound healing characteristics. The laser soldering system presented here should be tested on larger animal models before adopting it for clinical usage.