Trial Outcomes & Findings for Bioprosthetic Mesh to Expand the Lower Pole in Tissue Expander Reconstruction (NCT NCT01310075)
NCT ID: NCT01310075
Last Updated: 2019-04-30
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
through study completion, an average of 1 year
Results posted on
2019-04-30
Participant Flow
This study began enrollment on 04/15/2011 and was closed to enrollment on 12/08/2015. All recruitment done at the University of Texas MD Anderson Cancer Center.
Participant milestones
| Measure |
Arm 1- Surgimend
Surgimend Mesh - 10 x 15 cm piece of fenestrated material is sewn to the fold, curved side along the fold, using vicryl suture.
|
Arm 2-Alloderm
Alloderm Mesh - 6 x 12 cm piece or 6 x 16 cm piece is trimmed into a semicircle and sewn into the inframammary fold using vicryl. The smooth side is placed against the implant.
Device: Alloderm 6 x 12 cm piece or 6 x 16 cm piece is trimmed into a semicircle and sewn into the inframammary fold using vicryl. The smooth side is placed against the
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
31
|
35
|
|
Overall Study
NOT COMPLETED
|
14
|
10
|
Reasons for withdrawal
| Measure |
Arm 1- Surgimend
Surgimend Mesh - 10 x 15 cm piece of fenestrated material is sewn to the fold, curved side along the fold, using vicryl suture.
|
Arm 2-Alloderm
Alloderm Mesh - 6 x 12 cm piece or 6 x 16 cm piece is trimmed into a semicircle and sewn into the inframammary fold using vicryl. The smooth side is placed against the implant.
Device: Alloderm 6 x 12 cm piece or 6 x 16 cm piece is trimmed into a semicircle and sewn into the inframammary fold using vicryl. The smooth side is placed against the
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Physician Decision
|
10
|
7
|
|
Overall Study
Protocol Violation
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Bioprosthetic Mesh to Expand the Lower Pole in Tissue Expander Reconstruction
Baseline characteristics by cohort
| Measure |
Arm 1
n=31 Participants
Surgimend
|
Arm 2
n=35 Participants
Alloderm
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Age, Continuous
|
48.06 years
n=99 Participants
|
48.69 years
n=107 Participants
|
48.39 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=99 Participants
|
35 participants
n=107 Participants
|
65 participants
n=206 Participants
|
|
Region of Enrollment
Guatemala
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: through study completion, an average of 1 yearPopulation: Of the 90 randomized participants, 66 (74%) were evaluable for the primary measure
Outcome measures
| Measure |
Arm 1
n=31 Participants
Surgimend
|
Arm 2
n=35 Participants
Alloderm
|
|---|---|---|
|
Number of Participants With Complications After Tissue Expander Replacement With Implant
|
10 participants
|
10 participants
|
Adverse Events
Arm 1
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Arm 2
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=31 participants at risk
Surgimend
|
Arm 2
n=35 participants at risk
Alloderm
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/31 • through study completion, an average of 1 year
|
2.9%
1/35 • through study completion, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/31 • through study completion, an average of 1 year
|
2.9%
1/35 • through study completion, an average of 1 year
|
|
General disorders
Pain
|
3.2%
1/31 • through study completion, an average of 1 year
|
0.00%
0/35 • through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Delayed wound healing
|
3.2%
1/31 • through study completion, an average of 1 year
|
0.00%
0/35 • through study completion, an average of 1 year
|
|
Infections and infestations
Infection
|
3.2%
1/31 • through study completion, an average of 1 year
|
0.00%
0/35 • through study completion, an average of 1 year
|
Other adverse events
| Measure |
Arm 1
n=31 participants at risk
Surgimend
|
Arm 2
n=35 participants at risk
Alloderm
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/31 • through study completion, an average of 1 year
|
8.6%
3/35 • through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/31 • through study completion, an average of 1 year
|
2.9%
1/35 • through study completion, an average of 1 year
|
|
General disorders
Pain
|
9.7%
3/31 • through study completion, an average of 1 year
|
22.9%
8/35 • through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/31 • through study completion, an average of 1 year
|
2.9%
1/35 • through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.00%
0/31 • through study completion, an average of 1 year
|
5.7%
2/35 • through study completion, an average of 1 year
|
|
Vascular disorders
Hematoma
|
0.00%
0/31 • through study completion, an average of 1 year
|
2.9%
1/35 • through study completion, an average of 1 year
|
|
Vascular disorders
Seroma
|
0.00%
0/31 • through study completion, an average of 1 year
|
2.9%
1/35 • through study completion, an average of 1 year
|
|
General disorders
Fatigue
|
3.2%
1/31 • through study completion, an average of 1 year
|
0.00%
0/35 • through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Delayed wound healing
|
6.5%
2/31 • through study completion, an average of 1 year
|
0.00%
0/35 • through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Wound dehiscensence
|
6.5%
2/31 • through study completion, an average of 1 year
|
2.9%
1/35 • through study completion, an average of 1 year
|
Additional Information
Dr. Mark W Clemens, Associate Professor, Plastic Surgery
UT MD Anderson Cancer Center
Phone: 713-794-1247
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place