Trial · NCT00708071
Efficacy and Safety Study of Fibrin Sealant With 4 IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated (FS VH S/D 4) in Face-Lift Procedures
NCT00708071, Phase 2, Completed, Baxter Healthcare Corporation; results first posted 2012-08-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Fibrin Sealant With 4 IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated (FS VH S/D 4) in Face-Lift Procedures. Trials, record NCT00708071. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00708071
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Fibrin Sealant With 4 IU/mL Thrombin, Vapor Heated, Solvent Detergent Treated (FS VH S/D 4) in Face-Lift Procedures
- NCT number
- NCT00708071
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 45 participants, actual
- Lead sponsor
- Baxter Healthcare Corporation
- Conditions
- Facial Rhytidectomy (Face-lift)
- Interventions
- Fibrin Sealant with 4 IU/ml Thrombin, Vapor-Heated, Solvent Detergent Treated Containing Synthetic Aprotinin (FS VH S/D 4)
- First posted
- 2008-07-02
- Last updated
- 2012-10-23
- Results first posted
- 2012-08-27
Source ClinicalTrials.gov
Registered outcomes35
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Visual Comparison of Ecchymosis at Postoperative Day 3 | Through Postoperative Day 3 | Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs. |
| Primary | Incidence of Adverse Events (AEs) Related to Study Product (FS VH S/D 4) Throughout the Study Period | Through Postoperative Day 14 (± 1) | |
| Secondary | Visual Comparison of Ecchymosis at Day 1 | Through Postoperative Day 1 | Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs. |
| Secondary | Visual Comparison of Ecchymosis at Day 5 | Through Postoperative Day 5 | Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs. |
| Secondary | Visual Comparison of Ecchymosis at Day 7 | Through Postoperative Day 7 | Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs. |
| Secondary | Visual Comparison of Ecchymosis at Day 10 | Through Postoperative Day 10 | Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs. |
| Secondary | Visual Comparison of Ecchymosis at Day 14 | Through Postoperative Day 14 | Comparison between the FS VH S/D 4 treated side of the face and the side treated using standard of care (SoC) assessed by 5 separate blinded reviewers using standard digital photographs. |
| Secondary | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 1 | Through Postoperative Day 1 | Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers \>25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved Statistical Analysis Plan (SAP) specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. |
| Secondary | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 3 | Through Postoperative Day 3 | Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers \>25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. |
| Secondary | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 5 | Through Postoperative Day 5 | Reviewers used photographs from postoperative Day 1, 3, 5, 7, 10, and 14. Differences are calculated as (SoC Grade) - (FS VH S/D 4 Grade). MMS for Post Rhytidectomy (Facelift) Ecchymosis: Grade 0= No bruising; Grade 1= Barely perceivable (easily hidden with makeup, yellowish color and affects limited area); Grade 2= Present, minimal (yellow color and covers ≤25% of operated area); Grade 3= Moderate (yellow color and covers \>25% of operated area, red color, blue color but covers a very small area); Grade 4= Extensive (blue color and covers more than just a very small area, dark purple color) The planned and approved SAP specified a pre-aggregation of the data whereby differences between the two sides of the face were computed first within participants to retain the inherent correlation (pairings) in the measures. Summary statistics and statistical tests were then computed on the differences between the two sides of the face using paired sample tests. |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 registered outcomesOutcomes35
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Visual Comparison of Ecchymosis at Postoperative Day 3 | Through Postoperative Day 3 | Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis. | participants | NUMBER |
| SECONDARY | Visual Comparison of Ecchymosis at Day 1 | Through Postoperative Day 1 | Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis. | participants | NUMBER |
| SECONDARY | Visual Comparison of Ecchymosis at Day 5 | Through Postoperative Day 5 | Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis. | participants | NUMBER |
| SECONDARY | Visual Comparison of Ecchymosis at Day 7 | Through Postoperative Day 7 | Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis. | participants | NUMBER |
| SECONDARY | Visual Comparison of Ecchymosis at Day 10 | Through Postoperative Day 10 | Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis. | participants | NUMBER |
| SECONDARY | Visual Comparison of Ecchymosis at Day 14 | Through Postoperative Day 14 | Per Protocol. If there is no majority (i.e., 3 or more in agreement) in the outcomes of the visual comparison of both sides of the face from the 5 blinded reviewers then the assessment will not contribute to the analysis. | participants | NUMBER |
| SECONDARY | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 1 | Through Postoperative Day 1 | Per Protocol | Scores on a scale | MEDIAN |
| SECONDARY | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 3 | Through Postoperative Day 3 | Per Protocol | Scores on a scale | MEDIAN |
| SECONDARY | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 5 | Through Postoperative Day 5 | Per Protocol | Scores on a scale | MEDIAN |
| SECONDARY | Difference in Marchac Grades Using A Modified Marchac Scale (MMS) of Ecchymosis Between Two Sides of Face Assessed by 5 Independent, Blinded Reviewers- Day 7 | Through Postoperative Day 7 | Per Protocol | Scores on a scale | MEDIAN |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 outcomesResults by group150
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Visual Comparison of Ecchymosis at Postoperative Day 3 | Participants With Less Ecchymosis Treated With FS VH S/D 4 | 5 | participants | ||
| Visual Comparison of Ecchymosis at Postoperative Day 3 | Participants With Less Ecchymosis Treated With SoC | 12 | participants | ||
| Visual Comparison of Ecchymosis at Postoperative Day 3 | Participants With Equal Ecchymosis On Both Sides | 11 | participants | ||
| Visual Comparison of Ecchymosis at Postoperative Day 3 | Participants With No Ecchymosis on Either Side | 0 | participants | ||
| Visual Comparison of Ecchymosis at Day 1 | Participants With Less Ecchymosis Treated With FS VH S/D 4 | 2 | participants | ||
| Visual Comparison of Ecchymosis at Day 1 | Participants With Less Ecchymosis Treated With SoC | 11 | participants | ||
| Visual Comparison of Ecchymosis at Day 1 | Participants With Equal Ecchymosis On Both Sides | 16 | participants | ||
| Visual Comparison of Ecchymosis at Day 1 | Participants With No Ecchymosis on Either Side | 0 | participants | ||
| Visual Comparison of Ecchymosis at Day 5 | Participants With Less Ecchymosis Treated With FS VH S/D 4 | 5 | participants | ||
| Visual Comparison of Ecchymosis at Day 5 | Participants With Less Ecchymosis Treated With SoC | 8 | participants |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Facelift Participants | 45 | |
| Overall Study | COMPLETED | Facelift Participants | 45 | |
| Overall Study | NOT COMPLETED | Facelift Participants | 0 |
Source ClinicalTrials.gov
Adverse events9
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Oedema | General disorders | Localized to SoC Side of Face | 3 | 45 | 4 |
| other | Oedema | General disorders | Localized to FS VH S/D 4 Side of Face | 3 | 45 | 3 |
| other | Oedema | General disorders | Non-localized AEs | 0 | 45 | 0 |
| other | Haematoma | Vascular disorders | Localized to SoC Side of Face | 7 | 45 | 7 |
| other | Haematoma | Vascular disorders | Localized to FS VH S/D 4 Side of Face | 0 | 45 | 0 |
| other | Haematoma | Vascular disorders | Non-localized AEs | 0 | 45 | 0 |
| serious | Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Localized to SoC Side of Face | 1 | 45 | 1 |
| serious | Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Localized to FS VH S/D 4 Side of Face | 0 | 45 | 0 |
| serious | Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-localized AEs | 0 | 45 | 0 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Localized to SoC Side of Face | ||
| Total, all-cause mortality | Localized to FS VH S/D 4 Side of Face | ||
| Total, all-cause mortality | Non-localized AEs | ||
| Total, other adverse events | Localized to SoC Side of Face | 10 | 45 |
| Total, other adverse events | Localized to FS VH S/D 4 Side of Face | 3 | 45 |
| Total, other adverse events | Non-localized AEs | 0 | 45 |
| Total, serious adverse events | Localized to SoC Side of Face | 1 | 45 |
| Total, serious adverse events | Localized to FS VH S/D 4 Side of Face | 0 | 45 |
| Total, serious adverse events | Non-localized AEs | 0 | 45 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23515377 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00708071
GET https://conductscience.org/api/trials/v1/NCT00708071/registered?page=2