Sterile Intra-Abdominal Fluid Collection Associated with Seprafilm Use

Hirata

J of Obstet and Gynaecol

et al. 2021

Aim This study aimed to identify the risk factors for vaginal cuff infection after laparoscopic hysterectomy for benign gynecological diseases. Methods We conducted a retrospective cohort study among 1559 Japanese women who underwent total laparoscopic hysterectomy (TLH) for benign indications between 2014 and 2018 at Teine Keijinkai Hospital in Sapporo, Japan. All patients received preoperative antibiotics based on appropriate timing, choice, and weight‐based dosing. We assessed the risk factors of vaginal cuff infection after TLH, including demographic and clinical variables, and patient‐ and surgery‐related factors, using univariable and multivariable logistic regression analyses. Results Among all the patients who underwent TLH, 71 cases of vaginal cuff infections (4.6%) were recorded. Univariate analyses showed that current smoking, pathological result of adenomyosis, use of Seprafilm as an antiadhesive material, white blood cell counts on postoperative day (POD) 2, C‐reactive protein (CRP) level on POD2 and postoperative vaginal cuff hematoma were significantly associated with an increased risk of vaginal cuff infection. In multivariate analysis, current smoking, use of seprafilm, CRP level on POD2 and vaginal cuff hematoma were significantly associated with an increased risk of vaginal cuff infection. Conclusion Current smoking, use of seprafilm, CRP level on POD2 and vaginal cuff hematoma were identified as significant risk factors of vaginal cuff infection in the 30 days after surgery in Japanese women who underwent TLH for benign indications.

Section: Discussionmentioning

confidence: 99%

Risk factors of vaginal cuff infection in women undergoing laparoscopic hysterectomy for benign gynecological diseases

Hirata

J of Obstet and Gynaecol

et al. 2021

“…Collections of sterile intra-abdominal fluids were identified in three subjects following the use of Seprafilm in colorectal surgery [ 49 ]. The subjects of each received 2 or 3 sheets of Seprafilm.…”

Section: Clinical Safety and Efficacy Studiesmentioning

confidence: 99%

Seprafilm® adhesion barrier: (2) a review of the clinical literature on intraabdominal use

et al. 2012

This study seeks to provide a review of the clinical data published as of July 2011 concerning the postsurgical adhesion barrier, Seprafilm (chemically modified hyaluronic acid and carboxymethylcelulose; Genzyme Corporation, Cambridge, MA). Included articles detail the application of Seprafilm for intraabdominal uses that have been approved (on-label) and those considered investigational (off-label) by the FDA. Medline and EMBASE Drugs and Pharmaceuticals databases were searched for all original clinical Seprafilm research published as of July 2011. All human Seprafilm intraabdominal clinical reports and studies, excluding those related to prosthetic mesh were included. Data extraction involved the systematic review of each article. The data synthesis is the summary of Seprafilm human intraabdominal clinical reports and studies describing safety and/or efficacy. The safety and efficacy of Seprafilm in reducing postoperative adhesions has been clearly demonstrated in abdominal and pelvic laparotomy. While reports have described the safe and successful use of Seprafilm following laparoscopy, pediatric laparotomy, and in patients with malignancy and/or infection, the safety and efficacy of Seprafilm use in these procedures has not been definitively established in randomized controlled trials.

“…Isolated case reports (27)(28)(29)(30)(31) have nonetheless described a paradoxically intense intra-abdominal in ammatory reaction at the site corresponding to Sepra lm® application which can make re-entry unsafe within the rst seven days. This could potentially make a relook laparotomy in the event of complications such as an anastomotic leak even riskier.…”

Section: Discussionmentioning

confidence: 99%

“…This could potentially make a relook laparotomy in the event of complications such as an anastomotic leak even riskier. These accounts have described a foreign body reaction causing intense in ammation, with foreign body granulomas found on biopsy (29). This dense, thick, glue-like mass can envelop the underlying small intestine and transverse colon with resultant high risk of iatrogenic enterotomy (30).…”

Section: Discussionmentioning

confidence: 99%

“…This foreign body reaction can alternatively create collections of sterile intra-abdominal uids were identi ed in three subjects following the use of Sepra lm® in colorectal surgery (29). These case studies were included in the retrospective study at the Cleveland Clinic which found use of Sepra lm® in restorative proctocolectomy was associated with pelvic collections (32,33).…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Seprafilm® and adhesive small bowel obstruction in colorectal/gastrointestinal surgery: An Updated Systematic Review

Choy,

Le,

Kong

2023

Preprint

Background The efficacy of Seprafilm® in preventing clinically significant adhesive small bowel obstruction (ASBO) is controversial and deserves further review. The aim of this review was to assess the utility of Seprafilm® in preventing clinically significant adhesive bowel obstruction after gastrointestinal operations, with particular focus on colorectal resections. The secondary aim was to provide an updated literature review on the safety profile of this implant. Methods An up-to-date systematic review was performed on the available literature between 2000–2023 on PubMed, EMBASE, Medline, and Cochrane Library databases. The main outcome measures were rates of adhesive bowel obstruction, as well as rates of intervention. The secondary outcome was the clinical safety profile of Seprafilm® as described in current literature. Results A total of 17 observational studies were included, accounting for 62,886 patients. Use of Seprafilm® was associated with a significant reduction in adhesive bowel obstruction events (OR 0.449, 95% CI: 0.3271 to 0.6122, p < 0.001), with preserved efficacy seen in laparoscopic cases. This did not translate into a reduced rate of reintervention. Clinicians should also be aware of isolated reports of a paradoxical inflammatory reaction leading to fluid collections after Seprafilm® use, although they appear uncommon. Conclusion Seprafilm® can be considered in select patients although further study to determine which patients will benefit most is required.