A Phase 2 interventional study of FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma) and Standard of care in Seroma and Hematoma, sponsored by Baxter Healthcare Corporation. Completed at 6 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-06.
Sponsored by Baxter Healthcare Corporation · Phase 2, Interventional, and Treatment
The purpose of the study is to compare the safety and efficacy of ARTISS versus standard of care in adhering tissue places and reducing seroma/hematoma formation in subjects undergoing abdominoplasty.
101 studies on the registry are indexed under Seroma; 22 are open to participants now.
This study's enrollment of 40 is below the median of 100 across 92 interventional studies indexed under Seroma.
Browse Seroma studies →Baxter Healthcare Corporation is the lead sponsor of 80 studies on the registry; 1 is open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 3 (30%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ARTISS will be used as an adjuvant to standard of care.
Biological: FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma)
Standard of care
Procedure: Standard of care
Drug page: Fibrin Tissue Adhesive
Dosage form: spray (aerosolized sealant), Dosage frequency: once (1 layer). ARTISS will be applied onto the fascia or the wound bed.
Also known as: ARTISS
Standard of care
Total Drainage Volume Collected Until Drain Removal
Drainage fluids were to be collected through the Blake drain and into the collection bulb. The drainage volume was measured and recorded daily until the removal of the drain. During scheduled visits, measurement was to be performed at the study site, and on non-visit day recording of the drainage volume was to be done by a visiting home care nurse (or other study personnel). The drain was ready to be removed when the drainage volume in a given 24 hour period was \<=30 cc.
Time frame: Day 0 (Surgery Day) to Day 90
Occurrence of Seroma
The investigator inspected each subject post surgery (Day 0) an each scheduled visit (Day 3, 7, 14, 28, 60, 90) to determine whether there were any areas on the abdominal wall that meet the definition of seroma. A seroma is a pocket of clear serous fluid that sometimes develops in the body after surgery. This fluid is composed of blood plasma that has seeped out of ruptured small blood vessels and inflammatory fluid produced by the injured and dying cells.
Time frame: Day 0 (Surgery Day) to Day 90
Occurrence of Hematoma
The investigator inspected each subject post surgery (Day 0) an each scheduled visit (Day 3, 7, 14, 28, 60, 90) to determine whether there were any areas on the abdominal wall that meet the definition of hematoma. A hematoma is a collection of blood outside of a blood vessel.
Time frame: Day 0 (Surgery Day) to Day 90
Time to Drain Removal
The drain was ready to be removed when the drainage volume in a given 24 hour period was \<=30cc.
Time frame: Day 0 (Surgery Day) up to Day 90
Number of Fluid Aspiration for Seromas
Number of interventions recorded.
Time frame: Day 0 (Surgery Day) to Day 90
Total Volume of Fluid Aspirations for Seromas
Volume of fluid recovered was recorded.
Time frame: Day 0 (Surgery Day) to Day 90
Change From Baseline in Postoperative Skin Sensitivity 2 Inches Above Umbilicus
Test administered on abdomen midline using a set of different size Semmes-Weinstein monofilaments. These instruments are used to measure the cutaneous sensory perception threshold of patients. Each monofilament represents a unique amount of force. The force applied by each monofilament increases with each ascending size. Testing begins with small to large monofilaments. A higher score indicates a greater loss of sensation. Evaluator Size=ES, Hand \& Dorsal Foot Thresholds=HDFT, Normal=N, Diminished Light Touch=DLT,Diminished Protective Sensation=DPS, Loss of Protective Sensation=LOPS, Deep Pressure Sensation Only=DPSO: ES=1.65 (minimum),HDFT=N;ES=2.36,HDFT=N;ES=2.44,HDFT=N;ES=2.83,HDFT=N;ES=3.22,HDFT=DLT;ES=3.61,HDFT=DLT;ES=3.84,HDFT=DPS;ES=4.08,HDFT=DPS;ES-4.17,HDFT=DPS;ES=4.31,HDFT=DPS;ES=4.56,HDFT=LOPS;ES=4.74,HDFT=LOPS;ES=4.93,HDFT=LOPS;ES=5.07,HDFT=LOPS;ES=5.18,HDFT=LOPS;ES=5.46,HDFT=LOPS;ES=5.88,HDFT=LOPS;ES=6.10,HDFT=LOPS;ES=6.45,HDFT=LOPS;ES=6.65 (maximum),HDFT=DPSO.
Time frame: Days 0 (Baseline), 3, 7, 14, 28, 60, 90
Change From Baseline in Postoperative Skin Sensitivity 1 Inch Below Umbilicus
Test administered on abdomen midline using a set of different size Semmes-Weinstein monofilaments. These instruments are used to measure the cutaneous sensory perception threshold of patients. Each monofilament represents a unique amount of force. The force applied by each monofilament increases with each ascending size. Testing begins with small to large monofilaments, pressing at a 90 degree angle for approximately 1.5 seconds against the skin until it bows then it is removed. The patient is instructed to respond when a stimuli is felt, and a score is applied based on the monofilament in use. A higher score indiactes a greater loss of sensation.
Time frame: Days 0 (Baseline), 3, 7, 14, 28, 60, 90
Summary of Pain Assessment by Visit
Subjects were to be presented with a non-verbal visual analogue scale (VAS) to measure the level of pain (rating 0 \[no pain\] to 10 \[worst possible pain\]) the patient experienced at the site of surgery at the time of the visit.
Time frame: Day 3, 7, 14, 28, 60, 90
Summary of Numbness Assessment by Visit
Subjects were to be presented with a non-verbal VAS to measure the level of numbness (rating 0 \[no numbness\] to 10 \[complete numbness\]) that the patient experienced at the time of the visit.
Time frame: Day 3, 7, 14, 28, 60, 90
| Milestone | ARTISS | Standard of Care |
|---|---|---|
| Started | 20 | 20 |
| Completed | 20 | 20 |
| Not completed | 0 | 0 |
Drainage fluids were to be collected through the Blake drain and into the collection bulb. The drainage volume was measured and recorded daily until the removal of the drain. During scheduled visits, measurement was to be performed at the study site, and on non-visit day recording of the drainage volume was to be done by a visiting home care nurse (or other study personnel). The drain was ready to be removed when the drainage volume in a given 24 hour period was \<=30 cc.
| mL | ARTISS | Standard of Care |
|---|---|---|
| Total Drainage Volume Collected Until Drain Removal | 407.45 ± 470.36 | 595.90 ± 519.46 |
The investigator inspected each subject post surgery (Day 0) an each scheduled visit (Day 3, 7, 14, 28, 60, 90) to determine whether there were any areas on the abdominal wall that meet the definition of seroma. A seroma is a pocket of clear serous fluid that sometimes develops in the body after surgery. This fluid is composed of blood plasma that has seeped out of ruptured small blood vessels and inflammatory fluid produced by the injured and dying cells.
| Events | ARTISS | Standard of Care |
|---|---|---|
| Occurrence of Seroma | 8 | 5 |
The investigator inspected each subject post surgery (Day 0) an each scheduled visit (Day 3, 7, 14, 28, 60, 90) to determine whether there were any areas on the abdominal wall that meet the definition of hematoma. A hematoma is a collection of blood outside of a blood vessel.
| Events | ARTISS | Standard of Care |
|---|---|---|
| Occurrence of Hematoma | 0 | 0 |
The drain was ready to be removed when the drainage volume in a given 24 hour period was \<=30cc.
| Days | ARTISS | Standard of Care |
|---|---|---|
| Time to Drain Removal | 6.8 ± 7.11 | 9.55 ± 5.82 |
Number of interventions recorded.
| Interventions | ARTISS | Standard of Care |
|---|---|---|
| Number of Fluid Aspiration for Seromas | 5 ± 4.34 | 3.2 ± 1.64 |
Volume of fluid recovered was recorded.
| mL | ARTISS | Standard of Care |
|---|---|---|
| Total Volume of Fluid Aspirations for Seromas | 226.13 ± 157.78 | 152.2 ± 150.34 |
Test administered on abdomen midline using a set of different size Semmes-Weinstein monofilaments. These instruments are used to measure the cutaneous sensory perception threshold of patients. Each monofilament represents a unique amount of force. The force applied by each monofilament increases with each ascending size. Testing begins with small to large monofilaments. A higher score indicates a greater loss of sensation. Evaluator Size=ES, Hand \& Dorsal Foot Thresholds=HDFT, Normal=N, Diminished Light Touch=DLT,Diminished Protective Sensation=DPS, Loss of Protective Sensation=LOPS, Deep Pressure Sensation Only=DPSO: ES=1.65 (minimum),HDFT=N;ES=2.36,HDFT=N;ES=2.44,HDFT=N;ES=2.83,HDFT=N;ES=3.22,HDFT=DLT;ES=3.61,HDFT=DLT;ES=3.84,HDFT=DPS;ES=4.08,HDFT=DPS;ES-4.17,HDFT=DPS;ES=4.31,HDFT=DPS;ES=4.56,HDFT=LOPS;ES=4.74,HDFT=LOPS;ES=4.93,HDFT=LOPS;ES=5.07,HDFT=LOPS;ES=5.18,HDFT=LOPS;ES=5.46,HDFT=LOPS;ES=5.88,HDFT=LOPS;ES=6.10,HDFT=LOPS;ES=6.45,HDFT=LOPS;ES=6.65 (maximum),HDFT=DPSO.
| Units on a Scale | ARTISS | Standard of Care |
|---|---|---|
| Day 3 | 0.92 ± 1.79 | 0.89 ± 1.69 |
| Day 7 | 0.55 ± 1.37 | 0.73 ± 1.34 |
| Day 14 | 0.78 ± 1.42 | 0.54 ± 1.08 |
| Day 28 | 0.63 ± 1.41 | 0.53 ± 1.28 |
| Day 60 | 0.5 ± 1.26 | 0.3 ± 1.46 |
| Day 90 | 0.38 ± 0.95 | 0.19 ± 1.17 |
Test administered on abdomen midline using a set of different size Semmes-Weinstein monofilaments. These instruments are used to measure the cutaneous sensory perception threshold of patients. Each monofilament represents a unique amount of force. The force applied by each monofilament increases with each ascending size. Testing begins with small to large monofilaments, pressing at a 90 degree angle for approximately 1.5 seconds against the skin until it bows then it is removed. The patient is instructed to respond when a stimuli is felt, and a score is applied based on the monofilament in use. A higher score indiactes a greater loss of sensation.
| Score on a Scale | ARTISS | Standard of Care |
|---|---|---|
| Day 3 | 1.81 ± 1.83 | 1.78 ± 1.67 |
| Day 7 | 1.47 ± 1.32 | 1.02 ± 1.52 |
| Day 14 | 1.28 ± 1.47 | 0.49 ± 1.25 |
| Day 28 | 1.21 ± 1.43 | 0.81 ± 1.45 |
| Day 60 | 0.97 ± 1.67 | 0.50 ± 1.55 |
| Day 90 | 1.00 ± 1.68 | 0.84 ± 1.42 |
Subjects were to be presented with a non-verbal visual analogue scale (VAS) to measure the level of pain (rating 0 \[no pain\] to 10 \[worst possible pain\]) the patient experienced at the site of surgery at the time of the visit.
| Score on a Scale | ARTISS | Standard of Care |
|---|---|---|
| Day 3 | 3.68 ± 2.40 | 4 ± 2.03 |
| Day 7 | 2.7 ± 2.11 | 2.8 ± 1.79 |
| Day 14 | 1.7 ± 1.53 | 1.7 ± 1.34 |
| Day 28 | 1.05 ± 1.73 | 0.37 ± 0.50 |
| Day 60 | 0.37 ± 0.76 | 0.3 ± 0.57 |
| Day 90 | 0.3 ± 0.92 | 0.15 ± 0.37 |
Subjects were to be presented with a non-verbal VAS to measure the level of numbness (rating 0 \[no numbness\] to 10 \[complete numbness\]) that the patient experienced at the time of the visit.
| Score on a Scale | ARTISS | Standard of Care |
|---|---|---|
| Day 3 | 5.16 ± 3.24 | 6.30 ± 2.39 |
| Day 7 | 5.50 ± 2.54 | 4.95 ± 2.21 |
| Day 14 | 4.45 ± 2.52 | 4.35 ± 2.32 |
| Day 28 | 3.25 ± 1.92 | 3.42 ± 2.61 |
| Day 60 | 3.37 ± 1.74 | 3.16 ± 2.29 |
| Day 90 | 2.85 ± 1.69 | 2.11 ± 1.91 |
Collected over 90 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ARTISS | 0/20 (0%) | 1/20 (5%) | 10/20 (50%) |
| Standard of Care | 0/20 (0%) | 0/20 (0%) | 7/20 (35%) |
| Event | ARTISS | Standard of Care |
|---|---|---|
| HypertensionVascular disorders | 1/20 | 0/20 |
| Event | ARTISS | Standard of Care |
|---|---|---|
| SeromaInjury, poisoning and procedural complications | 8/20 | 5/20 |
| NauseaGastrointestinal disorders | 3/20 | 0/20 |
| Skin NecrosisSkin and subcutaneous tissue disorders | 0/20 | 2/20 |
| ConstipationGastrointestinal disorders | 1/20 | 0/20 |
| VomitingGastrointestinal disorders | 1/20 | 0/20 |
| Incision Site InfectionInfections and infestations | 1/20 | 1/20 |
| Abdominal AbscessInfections and infestations | 0/20 | 1/20 |
| CellulitisInfections and infestations | 0/20 | 1/20 |
| Urinary Tract InfectionInfections and infestations | 1/20 | 0/20 |
| Wound DehiscenceInjury, poisoning and procedural complications | 1/20 | 0/20 |
| Age, Continuous(Years) | ARTISS | Standard of Care | Total |
|---|---|---|---|
| Mean | 40.90 ± 7.89 | 45.60 ± 10.32 | 43.25 ± 9.38 |
| Sex: Female, Male(Participants) | ARTISS | Standard of Care | Total |
|---|---|---|---|
| Female | 20 | 19 | 39 |
| Male | 0 | 1 | 1 |
| Ethnicity (NIH/OMB)(Participants) | ARTISS | Standard of Care | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 7 | 13 |
| Not Hispanic or Latino | 14 | 13 | 27 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | ARTISS | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 18 | 20 | 38 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
The record gives a start of May 2010, a primary completion of Dec 2010 and a completion of Feb 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2018, 7 years 7 months after primary completion. A results delay was requested in Feb 2012.
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This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fibrin Tissue Adhesive
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