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Adjuvant use of fibrin glue (FG) in the fistula tract has been shown to promote closure of low-output enterocutaneous fistulas (ECFs). The primary objectives of this study are to compare the clinical efficacy, safety of autologous platelet-rich fibrin glue (PRFG), commercial fibrin glue, and control therapy in the management of patients with low-output volume ECFs.
This is a prospective, randomized, multi-centered study clinical, safety and economic outcome of ECFs patients.
Subjects are randomized to one of 3 groups:
Study will include three phases:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRFG treatment | Experimental | As described in our previous study, platelet-rich cryoprecipitate and thrombin were obtained from 300-400ml whole blood of each patient enrolled in the PRFG group and then frozen at -20°C for storage. Prior to application, frozen cryoprecipitate and thrombin stored were thawed in a 37°C water bath. Aminomethylbenzoic Acid (1ml: 1mg, Sigma-Aldrich, St Louis, MO) was added into the cryoprecipitate in the volume ratio of 1:10. |
|
| Control | Sham Comparator | Patients in this group only received standard of care when their fistula output < 200ml/24h. |
|
| Commercial FG | Experimental | Commercial FG (Zhejiang Puji Porcine fibrin sealant) was applied to close fistulas. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopy exploration and glue application | Procedure | A forward-viewing fistula-fiberscope (EndoView, Outai Medical Equipment, Shanghai, China), with 15cm length and 5mm width of fiber optical wire, was inserted into the fistula tract to accomplish endoscopic visualization. Briefly, the fistula-fiberscope assisted procedure was carried out percutaneously, allowing the exposure of internal hole and the whole tracts, followed by insertion of this catheter with distal mixing device. |
| Measure | Description | Time Frame |
|---|---|---|
| Closure rates up to 14 days | The fraction of patients with complete closure of fistula during 14 days | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | Incidence of adverse events and severe adverse events up to 180 days (defined as an event that was fatal or life-threatening, led to additional hospitalization or disability, or required an intervention to prevent one of these outcomes) | Participants will be followed for at least 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Economic outcome | Hospital cost upon enrollment, Hospital cost during entire hospital stay, Cost between fistula onset and final outcome | From fistula onset to the end of treatment, which is at least 180 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianan Ren, MD | Contact | 862580860108 | jiananr@gmail.com | |
| XIUWEN WU | Contact | 862580860008 | xiuwenwoo@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianan Ren, MD | Jinling Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinling Hospital | Recruiting | Nanjing | Jiangsu | 210002 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26445823 | Derived | Wu X, Ren J, Wang G, Wang J, Wang F, Fan Y, Li Y, Han G, Zhou Y, Song X, Quan B, Yao M, Li J. Evaluating the use of fibrin glue for sealing low-output enterocutaneous fistulas: study protocol for a randomized controlled trial. Trials. 2015 Oct 7;16:445. doi: 10.1186/s13063-015-0966-9. |
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| ID | Term |
|---|---|
| D007412 | Intestinal Fistula |
| ID | Term |
|---|---|
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000900 | Anti-Bacterial Agents |
| D002442 | Ceftazidime |
| D002439 | Cefotaxime |
| D000077731 | Meropenem |
| D044623 | Nutrition Therapy |
| ID | Term |
|---|---|
| D000890 | Anti-Infective Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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|
| Endoscopy exploration | Procedure | A forward-viewing fistula-fiberscope (EndoView, Outai Medical Equipment, Shanghai, China), with 15cm length and 5mm width of fiber optical wire, was inserted into the fistula tract to accomplish endoscopic visualization. |
|
| Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin) | Drug | Antibacterial therapy in patients with signs of systemic sepsis or local inflammation with pain |
|
|
| Nutrition support | Dietary Supplement | Nutritional replacement and bowel rest via enteral or parenteral nutrition |
|
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002509 |
| Cephaloridine |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002505 | Cephacetrile |
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D013812 | Therapeutics |