ALLODERM -
The Use of Alloderm in Breast
Reconstruction Surgery
METHOD: Peer reviewed English language publications of human, Theraputic Studies only – investigating the efficacy and safety of Alloderm in breast reconstruction. Repetitive evaluation and similar results of same data sets were not included.
TOTAL: 19 ALLODERM STUDIES
16 Studies
0 Studies
2 Studies
16 Level IV
0 Studies
2 Level III
The preponderance of studies are favorable, but are exclusively level IV evidence and therefore a Two Star ** rating (>25% of studies are Level IV). Although the product may be better then others in the same category, there is lack of high levels of evidence to support this.
Click Here for description of Evidence Based Medicine
Click Here for description of AME Rating System
ALLODERM
Studies Favorable: Total 16
Level IV: 16 Studies
1. Inferolateral AlloDerm hammock for implant coverage in breast reconstruction
Breuing KH, Colwell AS.
Ann Plast Surg. 2007 Sep;59(3):250-5.
Study Design: Case series
Level IV – FAVORABLE for Alloderm: Implant reconstruction with an inferolateral AlloDerm hammock facilitates positioning of the implant in immediate or revisional breast reconstruction and simplifies expander-implant reconstruction. This safe technique is easy to learn and should be considered a viable option for breast reconstruction.
2. Use of AlloDerm in primary nipple reconstruction to improve long-term nipple projection
Garramone CE, Lam B.
Plast Reconstr Surg. 2007 May;119(6):1663-8.
Study Design: Case series
Level IV – FAVORABLE for Alloderm: The authors’ results demonstrate that the use of a modified star dermal flap pattern with the placement of an AlloDerm graft core is a safe, easily performed, and reproducible technique for improving the long-term maintenance of projection in reconstructed nipples.
3. Use of regenerative human acellular tissue (AlloDerm) to reconstruct the abdominal wall following pedicle TRAM flap breast reconstruction surgery
Glasberg SB, D’Amico RA.
Plast Reconstr Surg. 2006 Jul;118(1):8-15
Study Design: Case series
Level IV – FAVORABLE for Alloderm: Based on these results, the authors recommend the use of AlloDerm as an alternative option for abdominal fascia closure after TRAM flap harvest for breast reconstruction.
4. Immediate bilateral breast reconstruction with implants and inferolateral AlloDerm slings
Breuing KH, Warren SM.
Ann Plast Surg. 2005 Sep;55(3):232-9.
Study Design: Case series
Level IV – FAVORABLE for Alloderm: This technique shortens or eliminates the need for tissue expansion and provides an additional option for single-stage breast reconstruction with implants. We have selectively used this technique as a reconstructive option for 10 women undergoing bilateral mastectomy (20 breasts).
5. Implant-based breast reconstruction with allograft
Zienowicz RJ, Karacaoglu E.
Plast Reconstr Surg. 2007 Aug;120(2):373-81.
Study Design: Case series
Level IV – FAVORABLE for Alloderm: Breast reconstruction with implant and AlloDerm enables the surgeon to create a submuscular pocket large enough to place a fully inflated breast implant. Interposition of a lower-pole internal sling, to increase the capacity of the pectoralis major pocket while providing immediate ability to achieve full or subtotal prosthetic fill and optimal aesthetic breast contouring and to maintain thicker muscle coverage in the upper and medial pole areas and stronger lower pole support, would obviate many of the current disadvantages to implant reconstruction.
6. Immediate single-stage breast reconstruction using implants and human acellular dermal tissue matrix with adjustment of the lower pole of the breast to reduce unwanted lift
Topol BM, Dalton EF, Ponn T, Campbell CJ.
Ann Plast Surg. 2008 Nov;61(5):494-9.
Study Design: Case series
Level IV – FAVORABLE for Alloderm: Human acellular dermal tissue matrix can successfully be used in conjunction with breast implants to achieve an aesthetically pleasing breast reconstruction in one stage at the time of skin-sparing mastectomy. The use of a tissue expander and its associated risks and costs are eliminated. The complication rate is low. In addition, either inframammary fold reconstruction or lower chest advancement and fold reconstruction to augment lower pole skin coverage can improve symmetry with the opposite breast.
7. Implant breast reconstruction using acellular dermal matrix
Gamboa-Bobadilla GM.
Ann Plast Surg. 2006 Jan;56(1):22-5.
Study Design: Case series
Level IV – FAVORABLE for Alloderm: The use of a human acellular dermal matrix in breast reconstruction is an alternative protocol in high-risk patients, resulting in a minimal increase in operative time and a decrease in morbidity compared with more extensive procedures.
8. Correction of chest wall deformity after implant-based breast reconstruction using poly-L-lactic acid (Sculptra)
Schulman MR, Lipper J, Skolnik RA
Breast J. 2008 Jan-Feb;14(1):92-6.
Study Design: Case series
Level IV – UNFAVORABLE for Alloderm: Placement of acellular cadaveric dermis (Alloderm) failed to improve the appearance of her chest wall. The authors utilized poly-L-lactic acid (Sculptra) for soft tissue augmentation of her chest wall with significant esthetic improvement. This novel use of poly-L-lactic acid offers a useful alternative to invasive surgical procedures to correct a soft tissue deformity of the chest wall. While poly-L-lactic acid has recently gained popularity for soft tissue augmentation of the face, to date, no reports in the literature exist describing its use in the correction of difficult chest wall defects after mastectomy and implant reconstruction. We maintain that poly-L-lactic acid may also be useful to improve a variety of soft tissue deformities of the breast.
9. Nonexpansive immediate breast reconstruction using human acellular tissue matrix graft (AlloDerm)
Salzberg CA.
Ann Plast Surg. 2006 Jul;57(1):1-5.
Study Design: Case series
Level IV – FAVORABLE for Alloderm: In this population, 49 patients (76 breasts) successfully underwent the acellular tissue matrix-based immediate reconstruction, resulting in durable breast reconstruction with good symmetry. These findings may predict that acellular tissue matrix-supplemented immediate breast reconstruction will become a new technique for the immediate reconstruction of the postmastectomy breast.
10. Acellular dermis-assisted breast reconstruction
Spear SL, Parikh PM, Reisin E, Menon NG.
Aesth Plast Surg (2008) 32:418–425
Study Design: Case series
Level IV – FAVORABLE for Alloderm: Acellular dermis appears to be a useful adjunct in immediate prosthetic breast reconstruction. Acellular dermis-assisted breast reconstruction has a low complication rate, helps to reconstruct an aesthetically pleasing breast, and facilitates expeditious completion of the reconstruction.
11. Intracapsular allogenic dermal grafts for breast implant-related problems
Baxter RA.
Plast Reconstr Surg. 2003 Nov;112(6):1692-6; discussion 1697-8.
Study Design: Case series
Level IV – FAVORABLE for Alloderm: Techniques for use of allogenic dermal grafts and early results from 10 patients are summarized in this article, along with histologic analysis confirming viability of the grafts at 6-month follow-up in one patient. No graft-related complications were identified.
12. Use of acellular cadaveric dermis and tissue expansion in postmastectomy breast reconstruction
Bindingnavele V, Gaon M, Ota KS, Kulber DA, Lee DJ.
J Plast Reconstr Aesthet Surg. 2007;60(11):1214-8. Epub 2007 Apr 25. Review.
Study Design: Case series
Level IV – FAVORABLE for Alloderm: The use of ACD in expansive postmastectomy breast reconstruction has an extremely low complication rate, results in good cosmetic outcome, and should be in the repertoire of plastic surgeons. Further follow up is needed to evaluate the long term outcomes of ACD use in postmastectomy breast reconstruction.
13. Alloderm (Acellular Human Dermis) in Breast Reconstruction with Tissue Expansion
Julio Hochberg, MD; Aaron Margulies, MD; James C. Yuen, MD; Julie Kepple, MD; Rhonda H. Tillman, MD; Scott Dorroh, BS; Amanda Pennington, RN; Kent Westbrook, MD; Suzanne Klimberg, MD
Plastic & Reconstructive Surgery. Abstract Supplement. 116, no 3, 2005.
Study Design: Case series
Level IV – FAVORABLE for Alloderm: The acellular human dermis allograt (Alloderm) is excellent for closure of the sub-pectoral pocket in breast reconstruction with tissue expanders. It maintains proper support of the fully inflated tissue expander without lateral displacement.The patient has immediate satisfaction with some breast volume and cleavage appearance, with a low rate of complications.
14. Immediate Breast Reconstruction with Tissue Expanders and Alloderm
Parikh, Pranay M. MD; Spear, Scott L. MD; Menon, Nathan MD; Reisin, Elan MD
Plastic & Reconstructive Surgery. Abstract Supplement. 118(4) Supplement:18, September 15, 2006.
Study Design: Case series
Level IV – FAVORABLE for Alloderm: Alloderm appears to be a useful adjunct in immediate prosthetic breast reconstruction. Use of Alloderm has a low complication rate, helps create an aesthetically pleasing breast, and affords an expeditious reconstruction.
15. Secondary Nipple Reconstruction Using Local Flaps and AlloDerm
Nahabedian, Maurice Y. M.D.
Plastic & Reconstructive Surgery. 115(7):2056-2061, June 2005.
Study Design: Case series
Level IV – FAVORABLE for Alloderm: Secondary nipple reconstruction using AlloDerm results in improved nipple projection. This was demonstrated in seven of eight nipple reconstructions (88 percent). In the only nipple that flattened, a tertiary reconstruction again using AlloDerm resulted in good projection. This limited experience has demonstrated that AlloDerm is simple to use, well tolerated, and has the potential for improved long-term nipple projection. Further studies are warranted.
16. Chest Wall Reconstruction with Acellular Dermal Matrix (AlloDerm) and a Latissimus Muscle Flap
Cothren, C Clay M.D.; Gallego, Kelly M.D.; Anderson, Erica D. M.D.; Schmidt, Douglas M.D.
Plastic and Reconstructive Surgery Volume 114(4), 15 September 2004, pp 1015-1017 ©2004American Society of Plastic Surgeons.
Study Design: Case series
Level IV – FAVORABLE for Alloderm: Although five pieces of AlloDerm had to be pieced together to span the 20 × 20-cm chest wall defect, it proved an ideal material, providing adequate structural stability and graftability without becoming infected, as could have happened with other prosthetic materials, despite partial inferior flap necrosis./p>
ALLODERM
Studies Unfavorable: Total 0
ALLODERM
Studies Neutral: Total 2
Level III: 2 Studies
1. AlloDerm versus DermaMatrix in immediate expander-based breast reconstruction: a preliminary comparison of complication profiles and material compliance
Becker S, Saint-Cyr M, Wong C, Dauwe P, Nagarkar P, Thornton JF, Peng Y.
Plastic and Reconstructive Surgery, Jan 2009, Vol 23, no. 1.
Study Design: Retrospective cohort study comparing Dermamatrix vs. Alloderm.
Level III – NEUTRAL for Alloderm: This study demonstrated no significant differences in the rate of complications or material compliance. The total complication rate was 4 percent, with seroma and wound infection being the most common complications. The authors’ preliminary findings indicate no significant difference between implant / expander-based reconstructions using AlloDerm and those using DermaMatrix./p>
2. The influence of AlloDerm on expander dynamics and complications in the setting of immediate tissue expander/implant reconstruction: a matched-cohort study
Preminger BA, McCarthy CM, Hu QY, Mehrara BJ, Disa JJ.
Ann Plast Surg. 2008 May;60(5):510-3
Study Design: Retrospective cohort study
Level III – NEUTRAL for Alloderm: Intraoperatively, expanders in the AlloDerm and non-AlloDerm cohorts were filled to a mean volume of 223.8 and 201.1 mL (P = 0.180). Median number of expansions performed was 5 and 6 in the AlloDerm and non-AlloDerm cohorts (P = 0.117). There was no difference in the mean rate of postoperative tissue expansion (AlloDerm: 97 mL/injection versus non-AlloDerm: 95 mL/injection [P = 0.907]), nor in the incidence of complications (P = 0.289). Minor complications occurred in 13.1% of AlloDerm cases (cellulitis [n = 3], seroma [n = 3], hematoma [n = 1]. Although this study does not address AlloDerm’s efficacy in decreasing morbidity or improving esthetic outcomes in TE/I reconstruction, it indicates that AlloDerm does not increase the rate of tissue expansion after immediate TE placement. It does not, however, appear to increase the risk of postoperative complications.
LEVEL I
Randomized, controlled clinical trials. Researchers would use a computer program to randomly assign patients with back pain into two groups of 20. The first group (placebo group known as the control) would drink water (that only tasted like pomegranate juice but was not) for 10 days. The second group would drink real pomegranate juice for 10 days. None of the patients would know if they were drinking the real pomegranate juice or not. (This is called a blinded study). Then a researcher who does not know which person drank what (which now makes this a what’s called a “double blinded” study) would interview the patients to determine if their back pain was reduced, worsened or stayed the same. After this was all done, the information about which patients drank what would then be revealed. One could then see if those who drank the real pomegranate juice were better or not than the water drinking group.
LEVEL II
Non-randomized, prospective comparative study. A researcher looks at 40 patients medical records to select 20 patients for the pomegranate drinking group and 20 patients for the control group who will drink water. This is called a “cohort,” namely a control and experimental patient make a cohort. Here the researcher may introduce his own bias whether he intends to or not. If he believes pomegranate is a safe, effective treatment for back pain then whether he means to or not he may put the healthier patients with less back pain in the pomegranate group and patients complaining of more back pain in the water-drinking group. (This particular bias is called “selection bias.” See section on types of research bias.)
LEVEL III
Retrospective (already occurred) comparative study or case controlled study (each “experimental“ patient is matched to a patient that never had the experimental). This is not a reliable standard for determining one treatment over another, though it can be helpful to, say, see how many complications a certain treatment has. Researchers do a retrospective study for example reviewing 20 patient records of patients who reported they have been drinking pomegranate juice in the past and then 20 patients who have not reported drinking pomegranate juice. Then the researchers review the patients’ medical records determine if the back pain was reported better, worse or stayed the same. Here again, the selection process may introduce bias intentionally or not. In this case it may not only be selection bias, but could involve “recall” bias, or “expectation bias” or “attention bias.” (See Bias in Research section).
LEVEL IV
Case series do not determine success or failure of a treatment compared to other treatments or no treatment at all. Researchers or a physician does a case study on 20 patients who drink pomegranate juice for 10 days and then report the results. In this case there is no control group or comparison to patients who are not drinking pomegranate juice. It does not take into consideration that back pain could get better in 10 days if the patient takes nothing at all for the pain. These studies are easier and cheaper. They can be of value to determine better methods of doing a particular treatment, or what the complications of a certain treatment are, but NOT for determining if one treatment is better than another.
LEVEL V
Expert opinion. One physician expert’s opinion on if pomegranate juice helps reduce back pain. No original research is conducted. Instead, just a written opinion or editorial that may talk about other research and give opinions, but no clinical study is conducted. AME considers this to be one step above hearsay for determining one treatment over another, though it may be valuable for stimulating discussion and ideas on a particular topic.
For More Information On Evidence Based Medicine Rating System Click Here.
