Evidence map›Paper›PMID 33704185›Full record

Trial reportCurrent oncology (Toronto, Ont.)2020

A Randomized Controlled Trial Comparing Alloderm-RTU with DermACELL in Immediate Subpectoral Implant-Based Breast Reconstruction.

Angel Arnaout, Jing Zhang, Simon Frank, Moein Momtazi, Erin Cordeiro, Amanda Roberts, Ammara Ghumman, Dean Fergusson, Carol Stober, Gregory Pond and 5 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Current oncology (Toronto, Ont.), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03064893 (A Randomised Controlled Trial Comparing the Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction), which is not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
1.8field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03064893 nacompletednot on this map

A Randomised Controlled Trial Comparing the Use of Alloderm Versus Dermacell in Immediate Implant Based Breast Reconstruction

TypeinterventionalSponsorOttawa Hospital Research InstituteRan2017 to 2019Enrolled62ConditionsBreast ReconstructionArmsAlloderm, Dermacell
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 21 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 2 institutions in 1 country.

Angel ArnaoutDepartment of Surgery, The Ottawa Hospital and University of Ottawa, Ottawa, ON K1Y 4E9, Canada.
Jing ZhangDepartment of Surgery, The Ottawa Hospital and University of Ottawa, Ottawa, ON K1Y 4E9, Canada.
Simon FrankDepartment of Surgery, The Ottawa Hospital and University of Ottawa, Ottawa, ON K1Y 4E9, Canada.
Moein MomtaziDepartment of Surgery, The Ottawa Hospital and University of Ottawa, Ottawa, ON K1Y 4E9, Canada.
Erin CordeiroDepartment of Surgery, The Ottawa Hospital and University of Ottawa, Ottawa, ON K1Y 4E9, Canada.
Amanda RobertsDepartment of Surgery, The Ottawa Hospital and University of Ottawa, Ottawa, ON K1Y 4E9, Canada.
Ammara GhummanDepartment of Surgery, The Ottawa Hospital and University of Ottawa, Ottawa, ON K1Y 4E9, Canada.
Dean FergussonOttawa Hospital Research Institute and University of Ottawa, Ottawa, ON K1H 8L6, Canada.
Carol StoberOttawa Hospital Research Institute and University of Ottawa, Ottawa, ON K1H 8L6, Canada.
Gregory PondJuravinski Cancer Center, McMaster University, Hamilton, ON L8S 4L8, Canada.
Ahwon JeongOttawa Hospital Research Institute and University of Ottawa, Ottawa, ON K1H 8L6, Canada.
Lisa VandermeerOttawa Hospital Research Institute and University of Ottawa, Ottawa, ON K1H 8L6, Canada.
Brian HuttonOttawa Hospital Research Institute and University of Ottawa, Ottawa, ON K1H 8L6, Canada.ORCID 0000-0001-5662-8647
Mark ClemonsOttawa Hospital Research Institute and University of Ottawa, Ottawa, ON K1H 8L6, Canada.
On Behalf Of The REaCT Investigators
University of Ottawa · CAJuravinski Cancer Centre · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe effectiveness of different acellular dermal matrices (ADM) used for implant-based reconstruction immediately following mastectomy is an important clinical question. A prospective randomized clinical trial was performed to evaluate the superiority of DermACELL over Alloderm-RTU in reducing drain duration.

methodsPatients undergoing mastectomy with subpectoral immediate and permanent implant-based breast reconstruction were randomized to Alloderm-RTU or DermACELL. The primary outcome was seroma formation, measured by the duration of postoperative drain placement. Secondary outcomes included: post drain removal seroma aspiration, infection, redbreast syndrome, wound dehiscence, loss of the implant, and unplanned return to the operating room.

results62 patients were randomized for 81 mastectomies (41 Alloderm-RTU, 40 DermACELL). Baseline characteristics were similar. There was no statistically significant difference in mean drain duration (

conclusionThis is the first prospective randomized clinical trial comparing the two most commonly used human-derived ADMs. There was no statistically significant difference in drain duration, minor, or major complications between DermACELL over Alloderm-RTU in immediate subpectoral permanent implant-based breast reconstruction post-mastectomy.

Indexed as

Breast NeoplasmsMammaplastyCollagenFemaleHumansMastectomyProspective StudiesRetrospective StudiesAllodermCollagenacellular dermal matriximmediate breast reconstructionmastectomy

Identifiers

PMID33704185
PMCPMC7816190
OpenAlexW3114567972

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.