An interventional study of Dermabond in Ascites and Fluid Loss, sponsored by Methodist Health System. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-07-10.
Sponsored by Methodist Health System · Not applicable, Interventional, and Health services research
Among 63 studies in Ascites with a site in United States — 11 open to participants now, 12 under way, none of them phase 3. Ascites · United States.
Among the 63 studies in Ascites with a site in United States, this one is the 10th largest by planned enrollment of the 52 interventional ones that give a count, is one of 4 that started in 2022, is one of 24 with no phase, reaches primary completion later than 0 of the 11 other live ones, and was the 50th registered.
247 studies on the registry are indexed under Ascites; 57 are open to participants now.
Browse Ascites studies →11 of the 63 studies in Ascites with a site in United States are open now. Recruiting first, the newest first:
University of Utah · Sites in United States
Ages 18+
W.L.Gore & Associates · Sites in United States, Italy
Ages 18+
CAMC Health System · Sites in United States
Ages 18+
Anahita Rabiee MD MHS · Sites in United States
Ages 18+
Milton S. Hershey Medical Center · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 41 Ascites studies recruiting now, 21 (51%) set no upper age limit and 13 (32%) stop at 75 or younger; 1 takes children under 18; 2 take healthy volunteers.
This study: 18 Years to 100 Years · all sexes · no healthy volunteers.
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63 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 15 · Phase 3 7 · Phase 4 4
First in 1997; this study’s year is marked. 4 started in 2022.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 134 is above the median of 54 across 179 interventional studies indexed under Ascites.
Median enrollment 49 across the 52 interventional studies, 53 across the 10 observational. Of the 44 that completed or were terminated, 17 (39%) have results posted.
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20 of 63 have an industry lead sponsor. The 10 most frequent:
Methodist Health System is the lead sponsor of 170 studies on the registry; 50 are open to participants now.
Methodist Health System has 1 study filed under Ascites — fewer than ten, so there is no comparison to draw.
6 of the studies in Ascites with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06812390Anahita Rabiee MD MHSAlbumin Assisted Diuresis in Patients with Cirrhosis and Ascites | 2026-12 |
| NCT06174272Milton S. Hershey Medical CenterTransitional Care Program for Fluid Overload in Cirrhosis | 2027-02-15 |
| NCT06764966CAMC Health SystemStatin and Beta Blocker Use in Patients With Decompensated Cirrhosis | 2027-03 |
| NCT05867602Baylor College of MedicineHigh Dose Albumin in Refractory Ascites | 2027-03-25 |
| NCT05726747Abramson Cancer Center at Penn MedicineQOL and Sarcopenia in Patients With Ascites | 2027-04 |
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Among the 63 studies in Ascites with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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Paracentesis is a commonly performed procedure in the inpatient and outpatient settings for treatment of ascites. The most frequent complication of paracentesis is fluid leak. Risk for this complication can be reduced by following the Z-track technique; however, fluid leaks still occur causing significant morbidity. 2-Octyl cyanoacrylate (2-OCA, Dermabond manufactured by Ethicon Inc) skin adhesive has been used for years for skin closure for wounds from surgical incisions including punctures from minimally invasive surgery and simple trauma lacerations.
Paracentesis is a commonly performed procedure in the inpatient and outpatient settings for treatment of ascites. The most frequent complication of paracentesis is fluid leak. Risk for this complication can be reduced by following the Z-track technique; however, fluid leaks still occur causing significant morbidity. 2-Octyl cyanoacrylate (2-OCA, Dermabond manufactured by Ethicon Inc) skin adhesive has been used for years for skin closure for wounds from surgical incisions including punctures from minimally invasive surgery and simple trauma lacerations. It has also been used for treatment of ascites fluid leaks following paracentesis with success in case reports. While the initial FDA approval included a contraindication for use on mucosal surfaces, some evidence in literature suggests that use on mucosal surfaces might warrant further investigation. For example, 2-OCA has been used for repair of a lacerated tongue of a pediatric patient and for closure of congenital cleft lips
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Exclusion Criteria:
Randomization will take place utilizing serial randomization to Glue Group (GG) and No Glue Group (NG) where skin closure will be assigned serially to a week of GG alternating with a week NG.
Other: Dermabond
Randomization will take place utilizing serial randomization to Glue Group (GG) and No Glue Group (NG) where skin closure will be assigned serially to a week of GG alternating with a week NG.
High viscosity Dermabond is a sterile, liquid topical skin adhesive containing monomeric (2-OCA) formulation and the colorant D \& C Violet # 2. The product has a syrup-like in viscosity and polymerizes within minutes when applied to the skin. 2-OCA is an effective barrier against microbial penetration by Gram-positive (inc. methicillin-resistant Staphylococcus aureus) and Gram-negative motile and nonmotile species as long the as the film is intact (11-13). The high viscosity of Dermabond is intended to reduce the risk of unintended placement of the adhesive during the application process to other body parts, patient's clothing or in between the skin layers in the wound, which can result in delayed wound healing.
Access topical 2-OCA application
To assess if topical 2-OCA application for skin closure would prevent post-paracentesis fluid leaks.
Time frame: up to 1 year
Access the rate of complications
Assess the rate of complications after topical 2-OCA application post-paracentesis such as skin infections, peritonitis, perforation of viscus, and bleeding.
Time frame: up to 1 year
Access post-paracentesis fluid leaks
Incidence of post-paracentesis fluid leaks within 48 hours of paracentesis and topical 2-OCA application
Time frame: up to 1 year
Incidence of bleeding from site
local irritation/burning, infections, and/or perforation within 48 hours post-procedure and topical 2-OCA application.
Time frame: up to 1 year.
Number of participants with complications from paracentesis procedure
Cellulitis, peritonitis, bleeding, perforated viscus
Time frame: up to 1 year
Number of participants with Evidence of Skin Reactions
itching, burning, sensation, redness, dermatitis
Time frame: up to 1 year
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2022 (actual). Primary completion is estimated for Jan 2024, 24 months after the start.
Of 33 interventional studies with no phase under Ascites, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 62. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
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