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Autologous Fibrin Glues for Fistulas Closure

Primary Purpose

Enterocutaneous Fistulas, Intra-abdominal Infection

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Autologous platelet-rich fibrin glue (PRFG)
Octreotide
Sponsored by
Jinling Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Enterocutaneous Fistulas focused on measuring Fibrin glue, Platelet, Autologous derivation, Prospective randomized trial, Fistulas

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • older than 18 years
  • presence of one or more fistulas
  • fistulas of low-output volume (< 200ml/24h)

Exclusion Criteria:

  • failure to meet inclusion criteria
  • mental handicap
  • extreme thinness
  • fistulous tract length < 2 cm
  • fistulous tract diameter > 1 cm
  • entero-atmospheric fistulas
  • Crohn's disease-related fistulas
  • any conditions that might impede spontaneous closure of the fistula, such as complex tracts, associated abscesses, residual disease, foreign bodies or distal obstruction
  • any conditions that might increase the risk of auto-transfusion, including hypertension, or diabetes; and acquired immune deficiency syndrome (AIDS)

Sites / Locations

  • Department of Surgery, Jinling Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

conservative therapy

Application of autologous PRFG

Arm Description

Conservative therapy includes orrection of electrolytic disturbances, suppression of gastric/intestinal secretion with octreotide, nutritional support.

The application of the glues through the external opening of the fistula was controlled by the drainage tube, which was based on fistulography to assure total occlusion of the internal hole. To allow the adhesion of the fibrin glues patch, all fistulous tracts were debrided to produce a smooth surface. At the time of procedures, the two components were mixed together to yield a gelatinous substance. After the FG was instilled, any redundant glue was removed from the external openings.

Outcomes

Primary Outcome Measures

counting time from enrollment or glue application to fistula closure or healing (d)
The primary measures were defined as the time required for fistula closure and also fistula healing after the last treatment received if in study group, or since enrollment if in control group. Closure was predefined as the absence of drainage through the external openings whether occurring spontaneously or under externally applied pressure. Healing was predefined as complete reepithelialization of external openings.

Secondary Outcome Measures

counting time from enrollment or glue application to enteral intake (d)
For secondary analyses, the time required to resume enteral intake from parenteral nutrition was collected. The hospitalization after enrollment, and also the proportion of patients with recurrence of a healed fistula during 12 months follow-up were evaluated. The incidence of adverse events and severe adverse events (defined as an event that was fatal or life-threatening, led to hospitalization or disability, or required an intervention to prevent one of these outcomes) was determined at each study visit.

Full Information

First Posted
March 16, 2012
Last Updated
February 23, 2013
Sponsor
Jinling Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT01561066
Brief Title
Autologous Fibrin Glues for Fistulas Closure
Official Title
Adjuvant Use of Autologous Platelet-rich Fibrin Glue in the Treatment of Fistulas and Anastomotic Leakages of the Digestive Tract
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Adjuvant use of fibrin glue in the fistula tract may promote healing in low-output enterocutaneous fistulas. However, there are only few studies that report autologous glue application in a larger patient group or clinical-controlled studies in this setting. The aim of this study was to investigate the efficacy and safety of autologous platelet-rich fibrin glue (PRFG) in the treatment of low-output digestive fistulas and compare them with conservative management without the use of adjuvant application of FG into the fistulous tract.
Detailed Description
The sudden appearance of intestinal contents draining from an abdominal incision is an emotionally devastating experience for both patients and surgeons. An enterocutaneous fistulas (ECF) is an abnormal communication between the bowel lumen and skin, often associated with fluid and electrolyte abnormalities, malnutrition, and sepsis. It is reported that spontaneous fistula closure rates vary from 15% to 71% after conservative treatment with wound care, control of infection, and nutritional support. Sufficient time should be allotted for the ECF to heal with conservative treatment, which also results in long-term discomfort. Adjuvant use of fibrin glue (FG) in the fistula tract may promote healing in low-output ECF. Containing high concentrations of human fibrinogen and thrombin, FG have been used extensively in many surgical fields as a biological adhesive system for tissue adhesion or hemostasis. Different types of FG are now employed: commercially produced and homemade autologous adhesives. Currently available FDA-approved commercial products such as Tisseel, Artiss (Baxter, Westlake Village, CA, USA), and Evicel (Johnson & Johnson, Somerville, NJ, USA) are widely used in clinical applications. Risks of infection transmission, allergic reactions, and also the high cost, however, still make autologous FG attractive. Additionally, in comparison with other adhesives, autologous compounds have several advantages in terms of biocompatibility and biodegradation. The aim of this study was to investigate the efficacy and safety of autologous platelet-rich fibrin glue (PRFG) in the treatment of low-output digestive fistulas and compare them with conservative management without the use of adjuvant application of FG into the fistulous tract.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enterocutaneous Fistulas, Intra-abdominal Infection
Keywords
Fibrin glue, Platelet, Autologous derivation, Prospective randomized trial, Fistulas

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conservative therapy
Arm Type
Sham Comparator
Arm Description
Conservative therapy includes orrection of electrolytic disturbances, suppression of gastric/intestinal secretion with octreotide, nutritional support.
Arm Title
Application of autologous PRFG
Arm Type
Active Comparator
Arm Description
The application of the glues through the external opening of the fistula was controlled by the drainage tube, which was based on fistulography to assure total occlusion of the internal hole. To allow the adhesion of the fibrin glues patch, all fistulous tracts were debrided to produce a smooth surface. At the time of procedures, the two components were mixed together to yield a gelatinous substance. After the FG was instilled, any redundant glue was removed from the external openings.
Intervention Type
Procedure
Intervention Name(s)
Autologous platelet-rich fibrin glue (PRFG)
Intervention Description
Preparation of autologous platelet-rich fibrin glues (PRFG) The platelet-rich plasma (PRP) was separated by centrifugation from 300-400 ml whole blood for 6 min at 1000g, 22°C twice, keeping most of the platelets (50%-60%) in the plasma fraction. For 50g PRP from each patient, with citric acid (2.84mM) lowering and NaHCO3 (75mM) adjusting the PH value, thrombin solution was produced. On the other hand, cryoprecipitate was produced from the rest of the plasma. Frozen at -80°C for at least 6h and then thawed at 4°C, PRP went through centrifugation at 4000rpm/min for 5min. PRFG application The application of the glues through the external opening of the fistula was controlled by the drainage tube through a double-syringe system with distal mixing device. The distance was based on fistulography to assure total occlusion of the internal hole. After the FG was instilled, any redundant glue was removed from the external openings.
Intervention Type
Drug
Intervention Name(s)
Octreotide
Other Intervention Name(s)
Octreotide Acetate Injection, Novartis, Switzerland
Intervention Description
subcutaneous injection, 0.3mg/8h until enteral nutrition resolution
Primary Outcome Measure Information:
Title
counting time from enrollment or glue application to fistula closure or healing (d)
Description
The primary measures were defined as the time required for fistula closure and also fistula healing after the last treatment received if in study group, or since enrollment if in control group. Closure was predefined as the absence of drainage through the external openings whether occurring spontaneously or under externally applied pressure. Healing was predefined as complete reepithelialization of external openings.
Time Frame
1-90 days
Secondary Outcome Measure Information:
Title
counting time from enrollment or glue application to enteral intake (d)
Description
For secondary analyses, the time required to resume enteral intake from parenteral nutrition was collected. The hospitalization after enrollment, and also the proportion of patients with recurrence of a healed fistula during 12 months follow-up were evaluated. The incidence of adverse events and severe adverse events (defined as an event that was fatal or life-threatening, led to hospitalization or disability, or required an intervention to prevent one of these outcomes) was determined at each study visit.
Time Frame
1-90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: older than 18 years presence of one or more fistulas fistulas of low-output volume (< 200ml/24h) Exclusion Criteria: failure to meet inclusion criteria mental handicap extreme thinness fistulous tract length < 2 cm fistulous tract diameter > 1 cm entero-atmospheric fistulas Crohn's disease-related fistulas any conditions that might impede spontaneous closure of the fistula, such as complex tracts, associated abscesses, residual disease, foreign bodies or distal obstruction any conditions that might increase the risk of auto-transfusion, including hypertension, or diabetes; and acquired immune deficiency syndrome (AIDS)
Facility Information:
Facility Name
Department of Surgery, Jinling Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
24183344
Citation
Wu X, Ren J, Gu G, Wang G, Han G, Zhou B, Ren H, Yao M, Driver VR, Li J. Autologous platelet rich fibrin glue for sealing of low-output enterocutaneous fistulas: an observational cohort study. Surgery. 2014 Mar;155(3):434-41. doi: 10.1016/j.surg.2013.09.001. Epub 2013 Oct 29.
Results Reference
derived

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Autologous Fibrin Glues for Fistulas Closure

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