Evaluation of 4DryField® as an Adhesion Prophylaxis in Pediatric Patients: A Propensity-Score Matched Study.

 Abdominal adhesions following surgery can lead to complications like intestinal obstruction and pelvic pain. While no molecular therapies currently target the underlying adhesion formation process, various barrier agents exist. 4DryField® has shown promise in reducing bleeding and adhesions in adults. This study aimed to assess its effectiveness in children.  The study examined all pediatric patients who underwent laparotomy between January 2018 and February 2022. It compared outcomes between those treated with 4DryField® and a control group. Key endpoints included surgical revision, adhesion recurrence, infections, insufficiencies, fever, C-reactive protein (CRP) levels, and time to gastrointestinal passage.  In total, 233 children had surgery for bowel adhesions. After propensity score matching, 82 patients were included in the analysis: 39 in the control and 43 in the 4DryField® group. 4DryField® did not affect the readhesion rate. Children in the treatment group had significantly more complications (47 vs. 15%, p = 0.002), more often fever, and higher CRP levels.  4DryField® did not show potential in reducing adhesion formation, but it was associated with significantly more complications in pediatric patients. Thus, future prospective studies are needed to evaluate the safety and effectiveness of 4DryField® in children.

Klinke M ，Dietze N ，Trautmann T ，Jank M ，Martel R ，Elrod J ，Boettcher M ... -  《-》

Evaluation of 4DryField® PH as Adhesion Prevention Barrier Tested in an Optimized Adhesion Model in Rats.

Adhesions due to pelvic/abdominal surgery are a common serious pathology possibly entailing severe complications. This study investigates the adhesion prevention capability of the novel starch-based agent 4DryField® PH, which together with saline solution forms a barrier gel. Herein, an optimized adhesion model (OPAM) inducing severe adhesions/agglutinations with high reproducibility was used. In 19 Lewis rats, a 1 × 2 cm abdominal wall defect was created, the peritoneum of the neighboring cecum was abraded, and both injured areas were approximated by suture. Rats were randomized to control (n = 10) or 4DryField PH treatment (n = 9) groups. Another 8 rats had sham surgery for safety assessment of 4DryField PH. At day 7, the quantity and quality of adhesions were assessed macro-/microscopically and evaluated statistically. 4DryField PH treatment significantly reduced the incidence and severity of adhesions as verified by significantly improved adhesion scorings (0.4 vs. 4.5; 1.1 vs. 9). Histology revealed reconstitution of the cecum and abdominal wall including regeneration of the visceral/parietal peritoneum. In sham-operated rats, 4DryField PH did not induce adhesion formation. 4DryField PH gel was highly effective in preventing adhesions. Histologically, the injured cecum and abdominal wall regenerated well in the presence of 4DryField PH. Considering the severity of OPAM trauma, the potential of 4DryField PH to prevent adhesions can be rated excellent.

Poehnert D ，Abbas M ，Kreipe HH ，Klempnauer J ，Winny M ... -  《-》

Reduction of adhesion formation after gynaecological adhesiolysis surgery with 4DryField PH - a retrospective, controlled study with second look laparoscopies.

Ziegler N ，De Wilde RL 《-》

Treatment of de-peritonealized intestine with 4DryField(®) PH prevents adhesions between non-resorbable intra-peritoneal hernia mesh and bowel.

Winny M ，Maegel L ，Grethe LV ，Jonigk D ，Borchert P ，Kaltenborn A ，Schrem H ，Klempnauer J ，Poehnert D ... -  《American Journal of Translational Research》

Evaluation of the Effectiveness of Peritoneal Adhesion Prevention Devices in a Rat Model.

Poehnert D ，Grethe L ，Maegel L ，Jonigk D ，Lippmann T ，Kaltenborn A ，Schrem H ，Klempnauer J ，Winny M ... -  《International Journal of Medical Sciences》