Trial Outcomes & Findings for Post-Operative Drainage Following Lymph Node Dissection (NCT NCT00324272)
NCT ID: NCT00324272
Last Updated: 2011-08-11
Results Overview
The postoperative wound drainage volume was measured from the day of surgery until the the date of removal of the last wound drain.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
74 participants
Primary outcome timeframe
From date of surgery to date of wound drain removal (typically a period of approximately one week).
Results posted on
2011-08-11
Participant Flow
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.
All 74 patients who were enrolled in the trial were followed up until 1.6.10 (unless they died prior to this date).
Participant milestones
| Measure |
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 Duploject™ 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.
|
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.
|
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 Duploject™ 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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
20
|
18
|
18
|
|
Overall Study
COMPLETED
|
18
|
20
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Post-Operative Drainage Following Lymph Node Dissection
Baseline characteristics by cohort
| Measure |
Groin Dissection: Sealant Used.
n=18 Participants
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 Duploject™ 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.
|
Groin Dissection: no Sealant Used.
n=20 Participants
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.
|
Axillary Dissection: Sealant Used.
n=18 Participants
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 Duploject™ 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.
|
Axillary Dissection: no Sealant Used.
n=18 Participants
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.
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Age Continuous
|
57.3 years
STANDARD_DEVIATION 17.9 • n=5 Participants
|
58.2 years
STANDARD_DEVIATION 18.1 • n=7 Participants
|
64.7 years
STANDARD_DEVIATION 18.4 • n=5 Participants
|
57.3 years
STANDARD_DEVIATION 14.2 • n=4 Participants
|
58.1 years
STANDARD_DEVIATION 17.1 • n=21 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
35 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
18 participants
n=5 Participants
|
20 participants
n=7 Participants
|
18 participants
n=5 Participants
|
18 participants
n=4 Participants
|
74 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From date of surgery to date of wound drain removal (typically a period of approximately one week).The postoperative wound drainage volume was measured from the day of surgery until the the date of removal of the last wound drain.
Outcome measures
| Measure |
Groin Dissection: Sealant Used.
n=18 Participants
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 Duploject™ 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.
|
Groin Dissection: no Sealant Used.
n=20 Participants
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.
|
Axillary Dissection: Sealant Used.
n=18 Participants
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 Duploject™ 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.
|
Axillary Dissection: no Sealant Used.
n=18 Participants
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.
|
|---|---|---|---|---|
|
Post-operative Wound Drainage.
|
892.5 ml
Interval 265.0 to 2895.0
|
762.5 ml
Interval 25.0 to 3255.0
|
565 ml
Interval 30.0 to 1835.0
|
590 ml
Interval 230.0 to 9605.0
|
SECONDARY outcome
Timeframe: From date of surgery until date of discharge from hospital.Population: 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.
The length of hospital stay was calculated from the day of surgery to the day that the patient was discharged from hospital.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of surgery until date of wound drain removal.The duration of postoperative wound drainage was measured from the day of surgery until the the date of removal of the last wound drain.
Outcome measures
| Measure |
Groin Dissection: Sealant Used.
n=18 Participants
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 Duploject™ 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.
|
Groin Dissection: no Sealant Used.
n=20 Participants
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.
|
Axillary Dissection: Sealant Used.
n=18 Participants
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 Duploject™ 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.
|
Axillary Dissection: no Sealant Used.
n=18 Participants
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.
|
|---|---|---|---|---|
|
Length of Time Drains Remain in Situ.
|
7 Days
Interval 5.0 to 15.0
|
7.5 Days
Interval 2.0 to 37.0
|
7.5 Days
Interval 1.0 to 15.0
|
9 Days
Interval 3.0 to 26.0
|
SECONDARY outcome
Timeframe: Until wound healing complete.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.
Outcome measures
| Measure |
Groin Dissection: Sealant Used.
n=18 Participants
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 Duploject™ 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.
|
Groin Dissection: no Sealant Used.
n=20 Participants
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.
|
Axillary Dissection: Sealant Used.
n=18 Participants
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 Duploject™ 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.
|
Axillary Dissection: no Sealant Used.
n=18 Participants
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.
|
|---|---|---|---|---|
|
Number of Patients With Post-operative Complications (Excluding Lymphoedema).
|
12 Participants
|
16 Participants
|
13 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: During the immediate post-operative period.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.
Outcome measures
| Measure |
Groin Dissection: Sealant Used.
n=18 Participants
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 Duploject™ 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.
|
Groin Dissection: no Sealant Used.
n=20 Participants
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.
|
Axillary Dissection: Sealant Used.
n=18 Participants
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 Duploject™ 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.
|
Axillary Dissection: no Sealant Used.
n=18 Participants
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.
|
|---|---|---|---|---|
|
Post Operative Pain Score Measured on 1st Post-operative Day.
|
1 Units on a scale.
Interval 1.0 to 1.25
|
2 Units on a scale.
Interval 1.0 to 3.0
|
2 Units on a scale.
Interval 1.0 to 3.0
|
2 Units on a scale.
Interval 1.0 to 2.0
|
SECONDARY outcome
Timeframe: From date of surgery until end of study follow-up period (1st June 2010)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).
Outcome measures
| Measure |
Groin Dissection: Sealant Used.
n=18 Participants
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 Duploject™ 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.
|
Groin Dissection: no Sealant Used.
n=20 Participants
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.
|
Axillary Dissection: Sealant Used.
n=18 Participants
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 Duploject™ 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.
|
Axillary Dissection: no Sealant Used.
n=18 Participants
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.
|
|---|---|---|---|---|
|
Disease Recurrence.
|
11 Participants.
|
6 Participants.
|
5 Participants.
|
8 Participants.
|
SECONDARY outcome
Timeframe: From day of surgery until end of study follow-up period (1st June 2010)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).
Outcome measures
| Measure |
Groin Dissection: Sealant Used.
n=18 Participants
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 Duploject™ 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.
|
Groin Dissection: no Sealant Used.
n=20 Participants
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.
|
Axillary Dissection: Sealant Used.
n=18 Participants
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 Duploject™ 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.
|
Axillary Dissection: no Sealant Used.
n=18 Participants
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.
|
|---|---|---|---|---|
|
Death.
|
10 Participants.
|
12 Participants.
|
9 Participants.
|
9 Participants.
|
Adverse Events
Groin Dissection: Sealant Used.
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Groin Dissection: no Sealant Used.
Serious events: 12 serious events
Other events: 0 other events
Deaths: 0 deaths
Axillary Dissection: Sealant Used.
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
Axillary Dissection: no Sealant Used.
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Groin Dissection: Sealant Used.
n=18 participants at risk
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 Duploject™ 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.
|
Groin Dissection: no Sealant Used.
n=20 participants at risk
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.
|
Axillary Dissection: Sealant Used.
n=18 participants at risk
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 Duploject™ 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.
|
Axillary Dissection: no Sealant Used.
n=18 participants at risk
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.
|
|---|---|---|---|---|
|
General disorders
Death
|
55.6%
10/18 • Number of events 10 • 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.
|
60.0%
12/20 • Number of events 12 • 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.
|
50.0%
9/18 • Number of events 9 • 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.
|
50.0%
9/18 • Number of events 9 • 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.
|
|
Skin and subcutaneous tissue disorders
Wound Seroma
|
22.2%
4/18 • Number of events 4 • 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.
|
10.0%
2/20 • Number of events 2 • 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.
|
27.8%
5/18 • Number of events 5 • 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.
|
27.8%
5/18 • Number of events 5 • 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.
|
|
Skin and subcutaneous tissue disorders
Wound cellulitis
|
5.6%
1/18 • Number of events 1 • 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.
|
15.0%
3/20 • Number of events 3 • 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.
|
5.6%
1/18 • Number of events 1 • 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.
|
0.00%
0/18 • 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.
|
|
Skin and subcutaneous tissue disorders
Wound necrosis
|
5.6%
1/18 • Number of events 1 • 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.
|
0.00%
0/20 • 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.
|
11.1%
2/18 • Number of events 2 • 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.
|
5.6%
1/18 • Number of events 1 • 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.
|
|
Skin and subcutaneous tissue disorders
Infected seroma
|
0.00%
0/18 • 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.
|
10.0%
2/20 • Number of events 2 • 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.
|
0.00%
0/18 • 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.
|
11.1%
2/18 • Number of events 2 • 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.
|
|
Skin and subcutaneous tissue disorders
Surgical seroma
|
16.7%
3/18 • Number of events 3 • 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.
|
30.0%
6/20 • Number of events 6 • 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.
|
16.7%
3/18 • Number of events 3 • 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.
|
0.00%
0/18 • 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.
|
|
Skin and subcutaneous tissue disorders
Haematoma
|
5.6%
1/18 • Number of events 1 • 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.
|
5.0%
1/20 • Number of events 1 • 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.
|
0.00%
0/18 • 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.
|
0.00%
0/18 • 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.
|
Other adverse events
Adverse event data not reported
Additional Information
Mr. Henk Giele, Consultant Plastic & Reconstructive Surgeon
John Radcliffe Hospital
Phone: 01865 231 056
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place