Comparison of Different Acellular Dermal Matrices in Breast Reconstruction: The 50/50 Study

Pittman, Troy A. M.D.; Fan, Kenneth L. M.D.; Knapp, Andrew B.S.; Frantz, Shelby B.S.; Spear, Scott L. M.D.

Plastic & Reconstructive Surgery: March 2017 - Volume 139 - Issue 3 - p 521–528
doi: 10.1097/PRS.0000000000003048
Breast: Original Articles
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Background: Acellular dermal matrix has enjoyed extensive use in primary and secondary alloplastic breast aesthetic and reconstructive surgery. The objective of this study was to examine clinical outcomes between available acellular dermal matrix products: DermACELL (LifeNet Health, Virginia Beach, Va.) and AlloDerm Ready To Use (LifeCell Corp., Branchburg, N.J.).

Methods: A retrospective chart review was performed on 58 consecutive patients (100 breasts) reconstructed with either DermACELL (n = 30 patients; 50 breasts) or AlloDerm Ready To Use (n = 28 patients; 50 breasts). The mastectomies were performed by three different breast surgeons. All reconstructions were performed by the same plastic surgeon (T.A.P.). Statistical analysis was performed by means of Fisher’s exact test.

Results: Differences in the average age, body mass index, percentage having neoadjuvant/adjuvant chemotherapy or breast irradiation, and numbers of therapeutic and prophylactic mastectomies between the two groups were not statistically significant (p < 0.05). Complications in both cohorts of patients were clinically recorded for 90 days after immediate reconstruction. When comparing outcomes, patients in the DermACELL group had a significantly lower incidence of “red breast syndrome” (0 percent versus 26 percent; p = 0.0001) and fewer days before drain removal (15.8 days versus 20.6 days; p = 0.017). No significant differences were seen in terms of seroma, hematoma, delayed healing, infection, flap necrosis, or explantation.

Conclusion: Patients reconstructed with DermACELL as compared with AlloDerm Ready To Use have significantly decreased number of days to drain removal and red breast syndrome and equivalent rates of other complications, including seroma, infection, flap necrosis, and explantation.

CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

This and Related “Classic“ Articles Appear on Prsjournal.Com for Journal Club Discussions.

Washington, D.C.

From the Department of Plastic Surgery, MedStar Georgetown University Hospital; Georgetown University School of Medicine; and private practice.

Received for publication March 9, 2016; accepted August 19, 2016.

Disclosure: Dr. Pittman is a consultant for MedTronic, Novadaq, and Sientra. Dr. Spear is a consultant for LifeCell, Allergan, Bonti, Motiva, and Novadaq. No funds were received or utilized for this research.

Troy A. Pittman, M.D., Department of Plastic Surgery, MedStar Georgetown University Hospital, Washington, D.C. 20007, troy.a.pittman@gunet.georgetown.edu

Article Outline

As a biological material, acellular dermal matrix was first introduced in 1994 for the treatment of extensive burn injuries.1 Human acellular dermal matrix is derived from tissue-banked deepithelialized cadaver skin processed to remove antigenic components and cellular debris, thus preventing host reaction while providing an excellent scaffold for tissue ingrowth and cell repopulation.2 The first use of acellular dermal matrix was reported in 2001, by Duncan, to correct rippling after breast implantation for soft-tissue–deficient patients.3 In 2005, Breuing and Warren described the use of acellular dermal matrix in the inferolateral pole to reestablish continuity of the pectoralis major.4 The physical properties of acellular dermal matrix make it similar to dermis, allowing elasticity and deformation under load, and resistance to tearing. This ability allows compliance during expansion in expander-based reconstruction and maintains lower pole coverage throughout the reconstruction process, leading to a more aesthetically pleasing lower breast pole. Since then, acellular dermal matrix has enjoyed extensive use in primary and secondary alloplastic breast aesthetic and reconstructive surgery.5–8

A number of acellular dermal matrix products are available on the market, beginning with AlloDerm, introduced in 1994 (LifeCell, Corp., Bridgewater, N.J.). AlloDerm is aseptically processed with sodium deoxycholate and sodium chloride, and freeze-dried. It requires refrigeration and must be soaked for a minimum of 5 minutes or until the backing separates in warm normal saline or lactated Ringer solution.9 It is then transferred to a second bath, which may contain antibiotics, until it is fully hydrated and pliable. AlloDerm Ready To Use is a similar product that is packaged in preservatives and does not require refrigeration or rehydration; however, it is recommended that the material be soaked for a minimum of 2 minutes in a sterile saline bath to remove the preservative before implantation.10

Although acellular dermal matrix use has become well accepted by many surgeons, concerns have been raised regarding the added cost of acellular dermal matrices and reports by some describing increased rates of infection, inflammatory reactions, and seroma, particularly compared with total submuscular reconstruction.9,11–14 Nahabedian found, in a study of 361 women, that the postoperative infection rate of breasts undergoing prosthetic-based reconstruction was 5.85 percent without AlloDerm and 5 percent with AlloDerm.15 In a meta-analysis on the efficacy and associated morbidities with acellular dermal matrix, Sbitany and Serletti found a statistically significant higher rate of seroma in expander implant reconstruction combined with acellular dermal matrix compared with total submuscular techniques (8.4 percent versus 4.3 percent, respectively).16 The addition of acellular dermal matrix has been associated with increased surgical complications, especially in smokers, those with elevated body mass indices, and those that have been previously irradiated.6,17

Recently, DermACELL (LifeNet Health, Virginia Beach, Va.) was introduced to the market. DermACELL is decellularized with an anionic detergent and endonuclease proprietary process called MatrACELL (LifeNet Health).18–20 This process removes more than 97 percent of donor DNA, indicating nearly complete decellularization and potentially reduced immunogenicity. Terminal sterilization is performed using low-dose gamma irradiation at low temperatures to achieve a sterility assurance level of 10−6. The product is stored at room temperature and is packaged in glycerol, making it ready to use without rehydration or rinsing.

With the increasing number of products available on the market, the obvious question becomes whether one product has advantages over the others. Few studies have been published comparing performance and complications among acellular dermal matrices.21,22 Given the high cost of acellular dermal matrices, and their different rates of infection, inflammatory reactions, and seroma formation, such a comparison is justified. The objective of our study was to compare clinical performance and complication rates between AlloDerm Ready To Use and DermACELL.

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PATIENTS AND METHODS

Charts of 58 consecutive patients (100 breasts) undergoing immediate breast reconstruction with either tissue expanders or implants following mastectomy were reviewed. Of the 58 consecutive cases reviewed, AlloDerm Ready To Use was used in the reconstruction of the first 28 consecutive patients (n = 50 breasts) and DermACELL was used in the second 30 consecutive patients (n = 50 breasts). All reconstructions were performed by a single plastic surgeon (T.A.P.), with one of three breast surgeons performing the mastectomies. Patients were selected for either nipple-sparing or skin-sparing mastectomy based on patient-specific anatomical and oncologic factors, as described by the senior author (S.L.S.).23 Both prophylactic and oncologic mastectomies were included. All operations were performed at MedStar Georgetown University Hospital. Each group contained a mixed cohort of immediate tissue expander and direct-to-implant reconstruction based on patient and/or surgeon preference. Generally, patients who received neoadjuvant chemotherapy or those with absolute indications for postoperative irradiation were chosen for direct-to-implant reconstructions, in an attempt to minimize postoperative complications.24

Chart review was performed to obtain patients’ relevant data, including age, body mass index, and medical history, and details regarding neoadjuvant or adjuvant chemotherapy and/or irradiation, indications for mastectomy, and type of mastectomy performed. Other outcomes of interest were the incidence of seroma, hematoma, “red breast syndrome,” delayed wound healing, mastectomy flap necrosis, cellulitis, infection, total reconstructive failure, and total number of days before drain removal. Adverse events that occurred within the first 90 days postoperatively in all patients were included. Analysis of outcomes was performed counting each breast independently, resulting in 50 breasts in each cohort.

In our analysis, red breast syndrome was defined as self-limiting erythema, in the absence of skin edema or induration, in an otherwise asymptomatic patient that was isolated to the lower pole of the breast in the distribution of the underlying acellular dermal matrix (Fig. 1), was refractory to oral antibiotics, and resolved without further complication.25 Cellulitis was defined as whole breast erythema and edema that resolved with oral antibiotics within 10 days. Presence of infection that progressed beyond cellulitis was based on criteria published by the Centers for Disease Control and Prevention, previously used by Ranganathan et al.22: (1) presence of purulent drainage; (2) positive aseptically obtained culture; (3) peri-incisional erythema and incision opened by the surgeon; or (4) physician diagnosis of infection, such as cellulitis, for which antibiotics were prescribed.22,26 Total reconstructive failure was defined as patients requiring complete explantation of their breast prosthesis. Delayed wound healing was recorded in patients with wound disruption that did not require surgical intervention, whereas mastectomy flap necrosis was recorded in patients that underwent sharp débridement and closure of the skin.

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Operative Technique

In all cases, acellular dermal matrix was used as an extension of the pectoralis major muscle. The pectoralis was released from its inferior and inferomedial attachments; a pocket was created beneath the muscle. On opening the package, the acellular dermal matrix was rinsed briefly in a bath of non–antibiotic-containing normal saline. Serial washing or soaking of the material was not attempted to completely remove the packing preservative from the acellular dermal matrix, as both products are marketed as “ready to use.” The acellular dermal matrix was sewn to the caudal border of the pectoralis muscle. The expanders or implants were placed beneath the pectoralis/acellular dermal matrix construct, and the acellular dermal matrix was sewn at the level of the inframammary fold using 3-0 Vicryl (Ethicon, Inc., Somerville, N.J.) suture. A single, 7-mm, flat Jackson-Pratt drain was placed in the area of the wound where fluid was most likely to accumulate and brought out through lateral stab incisions. In tissue expander cases, the drain was placed between the tissue expander and the acellular dermal matrix. In direct-to-implant cases, the drain was placed between the implant and the mastectomy flap. The AlloDerm Ready To Use consisted of perforated contour medium pieces and the DermACELL used consisted of 8 × 16-cm pieces that were fenestrated 1:1 using the Brennan mesher (Molnlycke Health Care, Gothenburg, Sweden). All patients received a dose of perioperative antibiotics, and oral antibiotics were continued until removal of the drains. Jackson-Pratt drain output was recorded independently by the patients, and drains were removed when output was less that 30 cc/day for 2 consecutive days.

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Statistical Analysis

Data were analyzed counting each breast independently. Adverse events were compared between cases in which AlloDerm Ready To Use was used and cases in which DermACELL was used for immediate breast reconstruction. Means and standard deviations were calculated for continuous variables, counts and percentages were calculated for categorical values, and p values were calculated using Fisher’s exact test. Values of p < 0.05 were considered to be statistically significant.

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RESULTS

There were 28 consecutive patients (50 breasts) who underwent reconstruction from December of 2014 to May of 2015 using AlloDerm Ready To Use. There were 30 consecutive patients (50 breasts) who underwent reconstruction from May of 2015 to August of 2015 using DermACELL. Differences in patient demographics between the two cohorts of patients were not statistically significant (Table 1). The average age and body mass index of the AlloDerm group was 46.0 years and 24.1 kg/m2, respectively. The average age and body mass index of the DermACELL group was 47.7 years and 25.8 kg/m2, respectively. Only one patient in the study was an active smoker (within 4 weeks of surgery) in the DermACELL group. There were no diabetic patients in our patient population. In the AlloDerm group, 33 of 50 mastectomies (66 percent) were nipple-sparing, with the remainder being skin-sparing. In the DermACELL group, 36 of 50 mastectomies (72 percent) were nipple-sparing, with the remainder being skin-sparing. The differences in the types of mastectomies in each group were not significant.

Thirty-seven of 50 breasts (74 percent) were reconstructed immediately with tissue expanders in the AlloDerm cohort with a mean initial expansion volume of 193 ± 84 ml. Twenty-eight of 50 breasts (56 percent) were reconstructed immediately with tissue expanders in the DermACELL group with a mean initial expansion volume of 188 ± 120 ml. The remainder of patients in each group underwent direct-to-implant reconstruction: 13 of 50 (26 percent) in the AlloDerm group and 22 of 50 (44 percent) in the DermACELL group. The average volume of implants placed in the direct-to-implant breasts was 463 ± 133 cc in the AlloDerm group and 443 ± 102 cc in the DermACELL group. Differences in the number of breasts reconstructed with expander/implant placement between the two groups did not reach statistical significance, nor did the differences between initial expander or implant volumes.

Twenty patients (71 percent) in the AlloDerm group underwent bilateral reconstructions, compared with 22 patients (73 percent) in the DermACELL group. Twenty-eight of the 50 breasts (56 percent) in the AlloDerm group were prophylactic, whereas 24 of the 50 breasts (48 percent) in the DermACELL group were prophylactic. Three of the 28 patients (11 percent) had received neoadjuvant chemotherapy in the AlloDerm group, versus eight of the 30 patients (27 percent) in the DermACELL group. One patient (2 percent) in each cohort had undergone unilateral whole breast irradiation on a single breast during breast conservation therapy before their mastectomy (one of 50 breasts). Five patients (10 percent) in each cohort underwent unilateral postreconstruction radiation therapy (five of 50 breasts). None of these differences was statistically significant.

Comparisons between outcomes in the 50 breasts reconstructed with AlloDerm and the 50 breasts reconstructed with DermACELL are listed in Table 2. All complications are reported per breast.

There was a significant decrease in time to drain removal with the DermACELL group compared with the AlloDerm group (15.8 days versus 20.6 days; p = 0.017). Looking independently at the tissue expander cohort versus the direct-to-implant cohort in each group, keeping all other variables relatively constant, including tissue expander initial fill and implant volumes, the average time to drain removal in the AlloDerm cohort was 22.7 days and 18.5 days, respectively. In the DermACELL cohort, the average time to drain removal was 17.5 days in the tissue expander cohort and 14.1 days in the direct-to-implant cohort.

There was a higher incidence of red breast syndrome in the AlloDerm population compared with the DermACELL population. Thirteen of 50 breasts (26 percent) developed red breast syndrome in the AlloDerm population, whereas no red breast syndrome was seen in the DermACELL group (p = 0.0001). Hematoma in the AlloDerm group was seen in two breasts (4 percent) versus zero breasts in the DermACELL group (p = 0.495). Seroma in the AlloDerm group was seen in 12 breasts (24 percent) versus five breasts (10 percent) in the DermACELL group (p = 0.069). Delayed wound healing was recorded in 10 of the 50 breasts (20 percent) in the AlloDerm group, versus four of the 50 breasts (8 percent) in the DermACELL group. Overt mastectomy flap necrosis requiring operative débridement occurred in two of 50 breasts (4 percent) in the AlloDerm cohort and four of 50 breasts (8 percent) in the DermACELL cohort (p = 0.678). All patients requiring operative débridement of necrotic mastectomy flaps went on to successful reconstruction. Cellulitis requiring oral antibiotics occurred in two of 50 breasts (4 percent) in each group. All patients with cellulitis, requiring oral antibiotics, went on to successful breast reconstruction. None of these patients progressed to overt infection requiring intravenous antibiotics or explantation. Infection beyond cellulitis, defined by the presence of purulent drainage, positive aseptically obtained culture, presence of frank pus after incision opened by the surgeon, and/or physician diagnosis of infection, occurred in three of 50 breasts (6 percent) in the AlloDerm cohort and in none of the DermACELL breast cohort. All patients diagnosed with infection went on to explantation of their implant and were thus counted as total implant failures.

Differences in time to drain removal and rate of red breast syndrome were statistically significant between the two groups. The rate of seroma between the two groups approached significance but was not found to be statistically significant (p = 0.069). All other reported complications, such as hematoma, delayed wound healing, flap necrosis, cellulitis, infection, and explantation, did not reach statistical significance when the two groups were compared.

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DISCUSSION

The primary objective of this study was to compare immediate breast reconstruction using AlloDerm Ready To Use versus DermACELL, a newer acellular dermal matrix with few clinical studies on its performance in breast reconstruction.18,27 Acellular dermal matrix use in breast reconstruction is now commonplace. Different acellular dermal matrix products vary by source tissue, processing, storage, surgical preparation, available sizes, and cost.9,28 Acellular dermal matrix has been used in immediate tissue expander–based breast reconstruction, allowing surgeons to increase expander fill, reconstruct the lower pole of the breast, and prevent superior retraction of the pectoralis.9 Furthermore, the natural evolution of immediate breast reconstruction has been the increasing popularity of direct-to-implant reconstruction.29–33

Several authors have found increased complications with the use of acellular dermal matrix in prosthesis-based reconstruction (i.e., infection, red breast syndrome, and increased rate of seroma).16,17,34 However, in comparing the use of acellular dermal matrix to total submuscular reconstruction, superior long-term aesthetic results and decreased rates of capsular contracture may outweigh the overall increased complication rate.13,35

In this study, complication rates for loss of implant, cellulitis, and surgical take-backs between AlloDerm Ready To Use and DermACELL were not significant. However, the incidence of red breast syndrome and the total number of days to drain removal were significant and favored the use of DermACELL.

The total number of days to drain removal are a reflection of the fluid generated by the acellular dermal matrix, and although seroma between the two acellular dermal matrices did not reach statistical significance, the prolonged drainage and the trend toward statistical significance suggest that this problem is more significant with AlloDerm. Throughout the study period, the incidence of direct-to-implant reconstruction in our practice increased, resulting in a larger, although not statistically significant, number of direct-to-implant reconstructions in the DermACELL cohort. To ensure that the decreased number of days to drain removal was not a result of this trend, we analyzed our data for each group independently. In both tissue expander and direct-to-implant reconstructions, the initial tissue expander fill volume and implant volume were similar in both cohorts. The average days to drain removal remained less in the DermACELL cohort, looking at the tissue expander group (17.5 days versus 22.7 days) and the direct-to-implant group (14.1 days versus 18.5 days) independently. We therefore conclude that regardless of the type of immediate reconstruction, the drains were removed faster in the DermACELL cohort. Perhaps these differences can be attributed to the differing decellularization techniques, the sterile processing, the packaging differences between the two products, or the difference in fenestrations present in the material. Although we acknowledge our “off-label” meshing of DermACELL deviates from standard protocol, we found this a simple and easy way to fenestrate the material without overmanipulating it. As hypothesized by Mowlds et al., fenestrations in acellular dermal matrix aid in egress of fluid from the subpectoral pocket.36 Although the acellular dermal matrix in each cohort was perforated and allowed placement of a single drain, perhaps the decreased number of days to drain removal is a result of differences in perforation techniques. We are actively in the process of further investigation into the ramifications of meshing or “microperforating” acellular dermal matrix.

AlloDerm Ready To Use is prepared from a cadaveric split-thickness skin graft processed aseptically with sodium chloride and sodium deoxycholate and freeze-dried. Its storage mechanism, the inner pouch, is not sterile, requires refrigeration, and requires two rehydration baths to wash. The newer product, AlloDerm Ready To Use, does not require refrigeration or rehydration; however, the manufacturer recommends a 2-minute sterile soak of the material before implantation despite the product being marketed as “ready to use.”

DermACELL is fully hydrated and ready for use with a sterile inner package. Decellularization is performed using proprietary MatrACELL technology, a nondenaturing anionic detergent and endonuclease–based decellularization process, which has been shown to remove greater than 97 percent of donor DNA, which exceeds the amount of DNA removed in GraftJacket (freeze-dried AlloDerm) or AlloDerm Ready To Use.18,20 Terminal sterilization is achieved using low-dose gamma irradiation at low temperatures to ensure a medical device sterility assurance level of 10−6. The product is finally packaged in glycerol, is stored at room temperature, and does not require rinsing of the material, thus making it truly ready to use out of the package.

Sterility assurance level is defined as the probability of a single unit being nonsterile after it has been subjected to sterilization. A sterility assurance level of 10−6 results in a one in 1 million chance that the material is contaminated, whereas a sterility assurance level of 10−3 has a one in 1000 chance of being contaminated. Although no regulatory standard exists for acellular dermal matrix, the U.S. Food and Drug Administration requires that all biological implants (i.e., orthopedic and cardiac prosthesis) have a sterility assurance level of at least 10−6.

DermACELL is the only non–freeze-dried acellular dermal matrix with a sterility assurance level of 10−6, whereas both AlloDerm and AlloDerm Ready To Use have a sterility assurance level of 10–3. This could possibly explain the trend toward the higher, but not statistically significant, rate of infection and seroma we experienced with AlloDerm Ready To Use.

In this study, red breast syndrome was treated as a distinct clinical entity, separate from cellulitis. We defined red breast syndrome as erythema overlying the lower pole of the breast in the distribution of the acellular dermal matrix. All patients were otherwise asymptomatic and showed no signs of elevated skin temperature, induration, or clinical evidence of infection. We noted a significant decrease in the incidence of red breast syndrome in our DermACELL cohort.

Red breast syndrome, first defined by Nahabedian, describes delayed erythema of the skin overlying the acellular dermal matrix recalcitrant to antibiotics, without systemic signs of infection such as fever or leukocytosis.15,37,38 Typically appearing days to weeks after reconstruction and being self-limiting, Rawlani et al. proposed red breast syndrome to be a result of poor incorporation, caused by seroma or inverted dermal-epidermal orientation, preventing revascularization, forcing host immune system to treat acellular dermal matrix as a foreign triggering inflammatory sequela.39 The overall incidence of red breast syndrome is largely unknown but is estimated to be as high as 7.6 percent.40,41 In a series by Ganske et al., results of punch biopsies of skin flaps with apparent red breast syndrome demonstrated a type IV hypersensitivity, T-cell–mediated immune response.25 In this study, patients were treated with systemic steroids and responded in 75 percent of the reported cases. In a meta-analysis of breast reconstruction using acellular dermal matrix, Kim et al. suggested a potential link between red breast syndrome and increasing rates of seroma.13 Nahabedian noted that erythema associated with acellular dermal matrix does seem to be attenuated or eliminated by washing the product in at least two baths.42

We noted red breast syndrome in 26 percent of our AlloDerm population, which is high compared with previously published reports. We attribute this high rate of red breast syndrome to the fact that, to maintain intraoperative efficiency, we treated the material as a true “ready-to-use” product and abandoned the 2-minute sterile bath before implantation, and instead performed a quick wash to remove the excess preservatives. We did not have any cases of red breast syndrome in our DermACELL population. Perhaps this statistically significant difference stems from allergens within the acellular dermal matrix, either retained DNA fragments or immunogenicity within packing preservatives. Although not the focus of the study, the incidence of red breast syndrome in the AlloDerm cohort may suggest that the product is not truly ready to use, still requires multiple baths to prepare it for use, increases operative time and requires additional setup.

In this study, the use of AlloDerm Ready To Use and DermACELL for immediate breast reconstruction was associated with an overall low complication rate in both groups. Both materials were well incorporated when tissue expanders were exchanged for implants. There was a trend toward lower rates of seroma and infection in the DermACELL population and a statistically significant lower incidence of red breast syndrome with faster removal of drains in the DermACELL population. We hypothesize that these differences are related to the processing and packaging of the individual products. Although a learning curve may be hypothesized to play a role in outcomes with any consecutive series, the primary surgeon (T.A.P.) had performed roughly 750 AlloDerm Ready To Use breast reconstructions before the study. There was less experience with DermACELL comparatively.

We acknowledge that the limitations of this study include the retrospective nature of data collection, the small sample size, and a relatively homogeneous population with a low body mass index and few comorbidities. We acknowledge that any study with drain removal as an endpoint may be flawed because we rely on patient-reported drain outputs. Given the relatively infrequent incidence of major complication with this procedure, a larger sample size would be needed to show a significant difference between the two cohorts when comparing rates of infection or total implant failure. However, given the high rate of red breast syndrome seen with AlloDerm, this study was adequately powered to significantly show a difference. Furthermore, the consecutive nature of our study decreases inherent biases in patient selection.

Our study serves as a pilot study for further analysis. These studies are underway. Future study will be prospective in nature; include a larger patient population; and examine aesthetic outcomes to capture long-term results of infection, seroma, capsular contracture, and implant failure.

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CONCLUSION

The use of DermACELL in immediate breast reconstruction is as safe and effective as AlloDerm Ready To Use and may have advantages in terms of inflammatory response as measured by the frequency of red breast syndrome and the time to drain removal.

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