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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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The purpose of this study is to determine whether the use of fibrin sealant reduces post-operative drainage following groin and axillary lymph node dissection.
Background: Fibrin sealant has been used for many years in clinical practice and has a wide range of applications including the control of lymphatic leaks and haemostasis. The physiological mechanism of action of fibrin was first described by Morawitz in 1905; fibrin sealant was first marketed in 1983.
Lymph node dissection is undertaken for the control of malignant disease - frequently malignant melanoma or squamous cell carcinoma. Following groin or axillary dissection, excessive post operative drainage may necessitate the presence of wound drains for 10 days or more. This may prolong hospital stay in some patients, and may be associated with an increased complication rate (such as wound infection).
Hypothesis: the use of fibrin sealant prior to wound closure following either groin or axillary dissection may reduce post-operative wound drainage.
Comparison: patients who require an elective groin or axillary dissection who either undergo standard wound closure or those who have fibrin sealant instilled into the surgical wound prior to wound closure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Groin dissection: sealant used. | Experimental |
| |
| Groin dissection: no sealant used. | Active Comparator |
| |
| Axillary dissection: sealant used. | Experimental |
| |
| Axillary dissection: no sealant used. | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibrin Sealant (Tisseel) used in the Experimental Arm. | Drug | For patients in the Experimental (Treatment) Arm, 4 ml of Tisseel fibrin sealant were instilled into the wound using the Duplojectâ„¢ spray delivery system prior to wound closure. Tisseelâ„¢ fibrin sealant was provided by Baxter Healthcare Ltd., Newbury, Berkshire, UK. For patients in the Active Comparator (Control) Arm, no fibrin sealant was used during wound closure (with the surgical procedure being identical in all other respects). |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative Wound Drainage. | The postoperative wound drainage volume was measured from the day of surgery until the the date of removal of the last wound drain. | From date of surgery to date of wound drain removal (typically a period of approximately one week). |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Inpatient Stay. | The length of hospital stay was calculated from the day of surgery to the day that the patient was discharged from hospital. | From date of surgery until date of discharge from hospital. |
| Length of Time Drains Remain in Situ. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henk P. Giele, MBBS FRACS | UK: National Health Service | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11743409 | Background | Oliver DW, Hamilton SA, Figle AA, Wood SH, Lamberty BG. A prospective, randomized, double-blind trial of the use of fibrin sealant for face lifts. Plast Reconstr Surg. 2001 Dec;108(7):2101-5, discussion 2106-7. doi: 10.1097/00006534-200112000-00044. | |
| 8985079 | Background | Moore MM, Nguyen DH, Spotnitz WD. Fibrin sealant reduces serous drainage and allows for earlier drain removal after axillary dissection: a randomized prospective trial. Am Surg. 1997 Jan;63(1):97-102. |
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All 74 patients who were enrolled in the trial were followed up until 1.6.10 (unless they died prior to this date).
Patient recruitment occurred between 1.1.2003 and 31.12.2006. A total of 74 patients were recruited. All patients were followed up until 1.6.2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Groin Dissection: Sealant Used. | All infrainguinal nodes, including Cloquet's node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the 'fast-set' preparation) were instilled into the wound using the Duplojectâ„¢ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied. |
| FG001 | Groin Dissection: no Sealant Used. | All infrainguinal nodes, including Cloquet's node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied. |
| FG002 | Axillary Dissection: Sealant Used. | A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the 'fast-set' preparation) were instilled into the wound using the Duplojectâ„¢ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied. |
| FG003 | Axillary Dissection: no Sealant Used. | A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Groin Dissection: Sealant Used. | All infrainguinal nodes, including Cloquet's node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the 'fast-set' preparation) were instilled into the wound using the Duplojectâ„¢ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Post-operative Wound Drainage. | The postoperative wound drainage volume was measured from the day of surgery until the the date of removal of the last wound drain. | Posted | Median | 95% Confidence Interval | ml | From date of surgery to date of wound drain removal (typically a period of approximately one week). |
|
From date of surgery (i.e. date of randomization) until the date of the adverse event (e.g. death, seroma formation) or the end of study follow-up period (1st June 2010) whichever is the sooner.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Groin Dissection: Sealant Used. | All infrainguinal nodes, including Cloquet's node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the 'fast-set' preparation) were instilled into the wound using the Duplojectâ„¢ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mr. Henk Giele, Consultant Plastic & Reconstructive Surgeon | John Radcliffe Hospital | 01865 231 056 | henk.giele@orh.nhs.uk |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D002294 | Carcinoma, Squamous Cell |
| D049291 | Seroma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D015718 | Fibrin Tissue Adhesive |
| ID | Term |
|---|---|
| D005337 | Fibrin |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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|
The duration of postoperative wound drainage was measured from the day of surgery until the the date of removal of the last wound drain. |
| From date of surgery until date of wound drain removal. |
| Number of Patients With Post-operative Complications (Excluding Lymphoedema). | Complications were classified as being either 'Minor' (i.e. (managed without operation, prolonged hospital stay or readmission) or 'Major' (i.e. requiring surgical intervention or readmission to hospital). The number of patients with each 'Minor' and 'Major' complication were recorded. | Until wound healing complete. |
| Post Operative Pain Score Measured on 1st Post-operative Day. | Pain score was recorded at 24 hours following the completion of surgery using a Visual Analogue Score (using a scale of 1 [no pain] to 10 [very severe pain]) which the patient was asked to record. | During the immediate post-operative period. |
| Disease Recurrence. | This was measured as either: 1. the number of participants with local recurrence; 2. the number of participants with in transit or regional recurrence; or 3. the number of participants with distant metastasis (but alive on 1st June 2010). | From date of surgery until end of study follow-up period (1st June 2010) |
| Death. | Death was recorded as the number of participants who had died by the end of the study follow-up period (1st June 2010). Deaths were recorded as either being related to the primary disease (i.e. due to distant metastasis) or death due to another (unrelated) cause (e.g. myocardial infarction or cerebrovascular accident). | From day of surgery until end of study follow-up period (1st June 2010) |
| 11518470 | Background | Berger A, Tempfer C, Hartmann B, Kornprat P, Rossmann A, Neuwirth G, Tulusan A, Kubista E. Sealing of postoperative axillary leakage after axillary lymphadenectomy using a fibrin glue coated collagen patch: a prospective randomised study. Breast Cancer Res Treat. 2001 May;67(1):9-14. doi: 10.1023/a:1010671209279. |
| 11265082 | Background | Giovannacci L, Renggli JC, Eugster T, Stierli P, Hess P, Gurke L. Reduction of groin lymphatic complications by application of fibrin glue: preliminary results of a randomized study. Ann Vasc Surg. 2001 Mar;15(2):182-5. doi: 10.1007/s100160010049. Epub 2001 Mar 1. |
| 14716794 | Background | Jain PK, Sowdi R, Anderson AD, MacFie J. Randomized clinical trial investigating the use of drains and fibrin sealant following surgery for breast cancer. Br J Surg. 2004 Jan;91(1):54-60. doi: 10.1002/bjs.4435. |
| 21456091 | Result | Swan MC, Oliver DW, Cassell OC, Coleman DJ, Williams N, Morritt DG, Giele HP. Randomized controlled trial of fibrin sealant to reduce postoperative drainage following elective lymph node dissection. Br J Surg. 2011 Jul;98(7):918-24. doi: 10.1002/bjs.7462. Epub 2011 Apr 1. |
| BG001 | Groin Dissection: no Sealant Used. | All infrainguinal nodes, including Cloquet's node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied. |
| BG002 | Axillary Dissection: Sealant Used. | A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the 'fast-set' preparation) were instilled into the wound using the Duplojectâ„¢ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied. |
| BG003 | Axillary Dissection: no Sealant Used. | A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Groin Dissection: no Sealant Used. | All infrainguinal nodes, including Cloquet's node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied. |
| OG002 | Axillary Dissection: Sealant Used. | A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the 'fast-set' preparation) were instilled into the wound using the Duplojectâ„¢ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied. |
| OG003 | Axillary Dissection: no Sealant Used. | A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied. |
|
|
|
| Secondary | Length of Hospital Inpatient Stay. | The length of hospital stay was calculated from the day of surgery to the day that the patient was discharged from hospital. | As the length of hospital stay was affected by numerous factors other than those related to the surgery itself (e.g. the patient's social circumstances), the results for this secondary outcome measure have not been presented. | Posted | Mean | Standard Deviation | Days | From date of surgery until date of discharge from hospital. |
|
|
| Secondary | Length of Time Drains Remain in Situ. | The duration of postoperative wound drainage was measured from the day of surgery until the the date of removal of the last wound drain. | Posted | Median | 95% Confidence Interval | Days | From date of surgery until date of wound drain removal. |
|
|
|
|
| Secondary | Number of Patients With Post-operative Complications (Excluding Lymphoedema). | Complications were classified as being either 'Minor' (i.e. (managed without operation, prolonged hospital stay or readmission) or 'Major' (i.e. requiring surgical intervention or readmission to hospital). The number of patients with each 'Minor' and 'Major' complication were recorded. | Posted | Number | Participants | Until wound healing complete. |
|
|
|
|
| Secondary | Post Operative Pain Score Measured on 1st Post-operative Day. | Pain score was recorded at 24 hours following the completion of surgery using a Visual Analogue Score (using a scale of 1 [no pain] to 10 [very severe pain]) which the patient was asked to record. | Posted | Median | Inter-Quartile Range | Units on a scale. | During the immediate post-operative period. |
|
|
|
|
| Secondary | Disease Recurrence. | This was measured as either: 1. the number of participants with local recurrence; 2. the number of participants with in transit or regional recurrence; or 3. the number of participants with distant metastasis (but alive on 1st June 2010). | Posted | Number | Participants. | From date of surgery until end of study follow-up period (1st June 2010) |
|
|
|
|
| Secondary | Death. | Death was recorded as the number of participants who had died by the end of the study follow-up period (1st June 2010). Deaths were recorded as either being related to the primary disease (i.e. due to distant metastasis) or death due to another (unrelated) cause (e.g. myocardial infarction or cerebrovascular accident). | Posted | Number | Participants. | From day of surgery until end of study follow-up period (1st June 2010) |
|
|
|
|
| 10 |
| 18 |
| 0 |
| 18 |
| EG001 | Groin Dissection: no Sealant Used. | All infrainguinal nodes, including Cloquet's node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied. | 12 | 20 | 0 | 20 |
| EG002 | Axillary Dissection: Sealant Used. | A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the 'fast-set' preparation) were instilled into the wound using the Duplojectâ„¢ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied. | 9 | 18 | 0 | 18 |
| EG003 | Axillary Dissection: no Sealant Used. | A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied. | 9 | 18 | 0 | 18 |
| Wound Seroma | Skin and subcutaneous tissue disorders | Systematic Assessment | Non-infected post-operative seroma requiring outpatient aspiration. In this category the seroma is neither infected nor does it require inpatient treatment (e.g. surgical drainage). |
|
| Wound cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Wound necrosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Infected seroma | Skin and subcutaneous tissue disorders | Systematic Assessment | Infected post-operative seroma requiring admission for intravenous antibiotics but not requiring surgical drainage. |
|
| Surgical seroma | Skin and subcutaneous tissue disorders | Systematic Assessment | Infected post-operative seroma requiring admission to hospital for incision & drainage procedure. |
|
| Haematoma | Skin and subcutaneous tissue disorders | Systematic Assessment | Post-operative haematoma requiring surgical drainage. |
|
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| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D018307 | Neoplasms, Squamous Cell |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 95 |
| No |
| Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| 0.301 |
| 95 |
| No |
| Superiority or Other |
| Distant metastasis in the groin cohort (with the patient being alive at the end of the study follow-up period on 1.6.10). | Fisher Exact | 0.474 | 95 | No | Superiority or Other |
| Local recurrence in the groin cohort. | Fisher Exact | 0.606 | 95 | No | Superiority or Other |
| In transit or regional recurrence in the axillary cohort. | Fisher Exact | 1.000 | 95 | No | Superiority or Other |
| Distant metastasis in the axillary cohort (with the patient being alive at the end of the study follow-up period on 1.6.10). | Fisher Exact | 0.486 | 95 | No | Superiority or Other |
| Regression, Cox |
| 0.338 |
| Hazard Ratio (HR) |
| 0.33 |
| 2-Sided |
| 95 |
| 0.03 |
| 3.20 |
| No |
| Superiority or Other |
| Death from metastatic disease in the axillary cohort. | Regression, Cox | 0.880 | Hazard Ratio (HR) | 0.93 | 2-Sided | 95 | 0.35 | 2.47 | No | Superiority or Other |
| Death from an unrelated cause in the axillary cohort. | Regression, Cox | 0.923 | Hazard Ratio (HR) | 0.923 | 2-Sided | 95 | 0.05 | 13.95 | No | Superiority or Other |