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Which graft is better for breast reconstruction? a Head-to-Head trial

NCT ID NCT03064893

Knowledge-focused Sponsor: Ottawa Hospital Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compared two types of skin grafts (Alloderm and Dermacell) used in immediate breast reconstruction after mastectomy. 62 women participated, and researchers tracked complications like infection, fluid buildup, and implant loss. The goal was to see if the cheaper option (Dermacell) works just as well as the more expensive one (Alloderm).

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

62 people

The number who actually took part.

Started

Feb 2017

Finished

Feb 2019

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 90 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Female patient * Ages 20-90 * All patients undergoing mastectomy for breast cancer or prophylaxis for breast cancer with immediate implant-based reconstruction * Able to provide verbal consent Exclusion Criteria: * Patients who have had prior chest wall or irradiation on the reconstructed side * Patients not undergoing immediate breast reconstruction at the time of mastectomy * Any patient with a contraindication to immediate breast reconstruction

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Conditions

The condition(s) this trial relates to.

breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast reconstruction

Contacts and locations

Locations

  • The Ottawa Hospital

    Ottawa, Ontario, K1H8L6, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.