Trial Outcomes & Findings for The Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction (NCT NCT03064893)

NCT ID: NCT03064893

Last Updated: 2026-01-30

Results Overview

Postoperative duration of drain placements for each postoperative breast.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 62 participants
• Primary outcome timeframe: within 6 months of initial surgery
• Results posted on: 2026-01-30

Participant Flow

Unit of analysis: breasts

Participant milestones

Measure	Dermacell Device for immediate implant based breast reconstruction Dermacell: Reconstruction material	Alloderm Device for immediate implant based breast reconstruction Alloderm: Reconstruction material
Overall Study STARTED	31 40	31 41
Overall Study COMPLETED	31 40	28 38
Overall Study NOT COMPLETED	0 0	3 3

Reasons for withdrawal

Measure	Dermacell Device for immediate implant based breast reconstruction Dermacell: Reconstruction material	Alloderm Device for immediate implant based breast reconstruction Alloderm: Reconstruction material
Overall Study Change in surgery plan	0	2
Overall Study Moved away	0	1

Baseline Characteristics

This is a baseline measure. The number of patients analyzed at baseline and follow-up are not equal.

Baseline characteristics by cohort

Measure	Dermacell n=31 Participants Device for immediate implant based breast reconstruction Dermacell: Reconstruction material	Alloderm n=31 Participants Device for immediate implant based breast reconstruction Alloderm: Reconstruction material	Total n=62 Participants Total of all reporting groups
Smoking history Current	1 Participants n=31 Participants • This is a baseline measure. The number of patients analyzed at baseline and follow-up are not equal.	3 Participants n=31 Participants • This is a baseline measure. The number of patients analyzed at baseline and follow-up are not equal.	4 Participants n=62 Participants • This is a baseline measure. The number of patients analyzed at baseline and follow-up are not equal.
Smoking history Prior (>1 or equal to month before)	10 Participants n=31 Participants • This is a baseline measure. The number of patients analyzed at baseline and follow-up are not equal.	9 Participants n=31 Participants • This is a baseline measure. The number of patients analyzed at baseline and follow-up are not equal.	19 Participants n=62 Participants • This is a baseline measure. The number of patients analyzed at baseline and follow-up are not equal.
Smoking history Never	20 Participants n=31 Participants • This is a baseline measure. The number of patients analyzed at baseline and follow-up are not equal.	19 Participants n=31 Participants • This is a baseline measure. The number of patients analyzed at baseline and follow-up are not equal.	39 Participants n=62 Participants • This is a baseline measure. The number of patients analyzed at baseline and follow-up are not equal.
Age, Continuous	51.4 years STANDARD_DEVIATION 11.0 • n=31 Participants • This is a baseline measure. The number of patients analyzed at baseline and follow-up are not equal.	47.8 years STANDARD_DEVIATION 11.1 • n=31 Participants • This is a baseline measure. The number of patients analyzed at baseline and follow-up are not equal.	49.6 years STANDARD_DEVIATION 11.1 • n=62 Participants • This is a baseline measure. The number of patients analyzed at baseline and follow-up are not equal.
Sex: Female, Male Female	31 Participants n=31 Participants	31 Participants n=31 Participants	62 Participants n=62 Participants
Sex: Female, Male Male	0 Participants n=31 Participants	0 Participants n=31 Participants	0 Participants n=62 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	31 participants n=31 Participants • This is a baseline measure. The number of patients analyzed at baseline and follow-up are not equal.	31 participants n=31 Participants • This is a baseline measure. The number of patients analyzed at baseline and follow-up are not equal.	62 participants n=62 Participants • This is a baseline measure. The number of patients analyzed at baseline and follow-up are not equal.

PRIMARY outcome

Timeframe: within 6 months of initial surgery

Population: Participants may have had surgery on one or both breasts.

Postoperative duration of drain placements for each postoperative breast.

Outcome measures

Measure	Dermacell n=40 breasts Device for immediate implant based breast reconstruction Dermacell: Reconstruction material	Alloderm n=38 breasts Device for immediate implant based breast reconstruction Alloderm: Reconstruction material
Postoperative Duration of Drain Placements	9.2 days Standard Deviation 4.5	10.8 days Standard Deviation 5.5

SECONDARY outcome

Timeframe: within 6 months of initial surgery

Outcome measures

Measure	Dermacell n=40 breasts Device for immediate implant based breast reconstruction Dermacell: Reconstruction material	Alloderm n=38 breasts Device for immediate implant based breast reconstruction Alloderm: Reconstruction material
Number of Breasts With an Episode of Seroma Formation Requiring Aspiration	5 breasts	2 breasts

SECONDARY outcome

Timeframe: within 6 months of initial surgery

Outcome measures

Measure	Dermacell n=40 breasts Device for immediate implant based breast reconstruction Dermacell: Reconstruction material	Alloderm n=38 breasts Device for immediate implant based breast reconstruction Alloderm: Reconstruction material
Number of Breasts With Loss of Implant	2 breasts	2 breasts

SECONDARY outcome

Timeframe: within 6 months of initial surgery

Outcome measures

Measure	Dermacell n=40 breasts Device for immediate implant based breast reconstruction Dermacell: Reconstruction material	Alloderm n=38 breasts Device for immediate implant based breast reconstruction Alloderm: Reconstruction material
Number of Breasts With Events of Revisional Surgery/ Return to Operating Room	3 breasts	6 breasts

SECONDARY outcome

Timeframe: within 6 months of initial surgery

Wound dehiscence is a post-operative complication. Wound debridement is a procedure. This outcome was collected on a post-surgery case report form.

Outcome measures

Measure	Dermacell n=40 breasts Device for immediate implant based breast reconstruction Dermacell: Reconstruction material	Alloderm n=38 breasts Device for immediate implant based breast reconstruction Alloderm: Reconstruction material
Number of Breasts With Wound Dehiscence or Debridement	2 breasts	3 breasts

SECONDARY outcome

Timeframe: within 6 months of initial surgery

Capsular contracture is a post-operative complication identified by the plastic surgeon. This outcome was collected on a post-surgery case report form.

Outcome measures

Measure	Dermacell n=40 breasts Device for immediate implant based breast reconstruction Dermacell: Reconstruction material	Alloderm n=38 breasts Device for immediate implant based breast reconstruction Alloderm: Reconstruction material
Number of Breasts With Capsular Contracture (as Identified by the Plastic Surgeon)	0 breasts	1 breasts

SECONDARY outcome

Timeframe: within 6 months of initial surgery

Population: The type of units is breasts. One participant could have had surgery on two breasts.

Outcome measures

Measure	Dermacell n=31 Participants Device for immediate implant based breast reconstruction Dermacell: Reconstruction material	Alloderm n=31 Participants Device for immediate implant based breast reconstruction Alloderm: Reconstruction material
Number of Plastic Surgeon Visits	3 visits Interval 3.0 to 4.5	4 visits Interval 3.0 to 5.0

SECONDARY outcome

Timeframe: 2 years

Population: Data for this outcome was not collected due to funding limitations. Data will not be collected in the future.

Economic impact will be assessed based on calculation of total costs with each material used to include the material costs, duration of operative room use, clinic and inpatient hospital costs, surgical billing costs and anaesthesia costs

Outcome measures

Outcome data not reported

Adverse Events

Dermacell

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Alloderm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jing Zhang

The Ottawa Hospital

Phone: 613-798-5555

Email: jzhang1@toh.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place