Kim, So-Young
(Department of Plastic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine)
,
Lim, So Young
(Department of Plastic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine)
,
Mun, Goo-Hyun
(Department of Plastic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine)
,
Bang, Sa-Ik
(Department of Plastic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine)
,
Oh, Kap Sung
(Department of Plastic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine)
,
Pyon, Jai-Kyong
(Department of Plastic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine)
Background CGCryoDerm was first introduced in 2010 and offers a different matrix preservation processes for freezing without drying preparation. From a theoretical perspective, CGCryoDerm has a more preserved dermal structure and more abundant growth factors for angiogenesis and recellularization. I...
Background CGCryoDerm was first introduced in 2010 and offers a different matrix preservation processes for freezing without drying preparation. From a theoretical perspective, CGCryoDerm has a more preserved dermal structure and more abundant growth factors for angiogenesis and recellularization. In the current study, the authors performed a retrospective study to evaluate freezing- and freeze-drying-processed acellular dermal matrix (ADM) to determine whether any differences were present in an early complication profile. Methods Patients who underwent ADM-assisted tissue expander placement for two stage breast reconstruction between January of 2013 and March of 2014 were retrospectively reviewed and divided into two groups based on the types of ADM-assisted expander reconstruction (CGDerm vs. CGCryoDerm). Complications were divided into four main categories and recorded as follows: seroma, hematoma, infection, and mastectomy skin flap necrosis. Results In a total of 82 consecutive patients, the CGCryoDerm group had lower rates of seroma when compared to the CGDerm group without statistical significance (3.0% vs. 10.2%, P=0.221), respectively. Other complications were similar in both groups. Reconstructions with CGCryoDerm were found to have a significantly longer period of drainage when compared to reconstructions with CGDerm (11.91 days vs. 10.41 days, P=0.043). Conclusions Preliminary findings indicate no significant differences in early complications between implant/expander-based reconstructions using CGCryoderm and those using CGDerm.
Background CGCryoDerm was first introduced in 2010 and offers a different matrix preservation processes for freezing without drying preparation. From a theoretical perspective, CGCryoDerm has a more preserved dermal structure and more abundant growth factors for angiogenesis and recellularization. In the current study, the authors performed a retrospective study to evaluate freezing- and freeze-drying-processed acellular dermal matrix (ADM) to determine whether any differences were present in an early complication profile. Methods Patients who underwent ADM-assisted tissue expander placement for two stage breast reconstruction between January of 2013 and March of 2014 were retrospectively reviewed and divided into two groups based on the types of ADM-assisted expander reconstruction (CGDerm vs. CGCryoDerm). Complications were divided into four main categories and recorded as follows: seroma, hematoma, infection, and mastectomy skin flap necrosis. Results In a total of 82 consecutive patients, the CGCryoDerm group had lower rates of seroma when compared to the CGDerm group without statistical significance (3.0% vs. 10.2%, P=0.221), respectively. Other complications were similar in both groups. Reconstructions with CGCryoDerm were found to have a significantly longer period of drainage when compared to reconstructions with CGDerm (11.91 days vs. 10.41 days, P=0.043). Conclusions Preliminary findings indicate no significant differences in early complications between implant/expander-based reconstructions using CGCryoderm and those using CGDerm.
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가설 설정
a)Breasts with more than one complication were counted once.
제안 방법
In addition, the total amount of drainage and drainage period were also calculated. Complications were divided into four main categories and recorded as follows: seroma, hematoma, infection, and mastectomy skin flap necrosis. Seroma was defined as clinically significant fluid collection that required percutaneous aspiration or surgical procedures.
One group included CGDerm and the other CGCryoDerm. The authors collected the following data from patient medical records: age, body mass index, smoking, neo adjuvant chemotherapy, and intraoperative findings including mastectomy weight, extent of axillary lymph node dissection, saline fill volume, and ratio to expander size. In addition, the total amount of drainage and drainage period were also calculated.
Taking into account the similar cost of both products and similar complication rates including seroma, this study suggests that the choice between these two products can be based on surgeon preference, given the equivalency of the products. The authors recognize that this study is a preliminary study of CGCryoDerm and therefore has limitations because of the small sample size and relatively short follow-up period. Unfortunately, our data were not powered sufficiently to determine whether the use of CGCryoDerm resulted in more favorable complication rates and long-term outcomes.
) [8]. The main study objective was to evaluate freezing alone (CGCryoDerm, CGBio Co.) and freeze-drying processed (CGCryoDerm, CGBio Co.) ADM to determine whether any differences were present in early complication profiles. Early postoperative outcomes, specifically rates of seroma formation as well drainage period, were used as clinical endpoints for evaluation.
대상 데이터
A retrospective chart review was performed and patients who underwent ADM-assisted tissue expander placement for two stage breast reconstruction by three plastic surgeons between January of 2013 and July of 2014 at Samsung Medical Center were included in the study. The authors included unilateral tissue expander placement because bilateral mastectomy is a confounding factor for drainage caused by decreased blood supply in the medial portion of the breasts due to disruption of internal thoracic perforators [9].
A total of 82 consecutive patients were included in the study and divided into two assisted tissue expander groups after total mastectomy: CGDerm (n = 49, 59.8%) and CGCryoDerm (n = 33, 40.9%). All patients were offered ADM immediately as an adjunct to their reconstruction.
데이터처리
Comparison of CGDerm and CGCryoDerm-assisted groups was performed using the Fisher’s exact test to evaluate the association between categorical variables and the two sample t-test for continuous variables.
성능/효과
We believed it was reasonable to hypothesize that CGCryoDerm has a better regenerative potential for incorporation and thus can lower seroma complication rates and have shorter drain periods when compared to CGDerm. According our results, CGCryoDerm had a lower incidence of seroma formation (n = 1/33, 3%) than the CGDerm group (n = 5/49, 10.2%), but this difference was not statistically significant. Lee et al.
By analyzing the preoperative demographics between the CGDerm and CGCryoDerm groups, patients were found to be statistically similar in age (42.31 years and 42.64 years, respectively; P = 0.857), body mass index (21.98 ㎡ /kg and 22.08 ㎡ /kg, respectively; P = 0.153), smoking status (10.2% and 6.1%, respectively; P = 0.510), and history of neo adjuvant chemotherapy (4.1% and 3.0%, respectively; P = 0.804) (Table 1).
[5] compared AlloDerm and CGCryoDerm groups for the presence of complications including seroma, infection, skin flap necrosis, capsular contracture, and implant loss during immediate breast reconstruction. In their study, the authors found no difference in clinically significant complications between the two groups, but the incidence of seroma was much lower in the CGCryoDerm group. This result is consistent with the findings in our study.
877) (Table 2). Regarding perioperative complications, the CGCryoDerm group had much lower rates of seroma when compared to the CGDerm group, but this result failed to achieve statistical significance at 3.0% vs. 10.2% (P = 0.221), respectively. Other complications were similar in both groups with incidence rates of 2.
Before analysis, the two groups in the present study were well matched in terms of age, body mass index, smoking, mastectomy weight, extent of lymph node dissection, and distribution of surgeons, all of which can affect complications and skew results if not controlled for. The results of the current study showed that there is no demonstrable difference in overall complications between the CGCryoDerm and CGDerm groups. With regards to the complication of seroma, it is known that seroma formation in the ADM-assisted expander might be caused by increased dead space due to a mismatch between the skin envelope and underlying expander before complete revascularization and incorporation of the ADM, which takes approximately 2 weeks as confirmed in a previous animal study [4,7].
후속연구
Unfortunately, our data were not powered sufficiently to determine whether the use of CGCryoDerm resulted in more favorable complication rates and long-term outcomes. To identify the long-term effect of better incorporation characteristics in CGCryoderm, further investigation regarding outcomes of CGCryoderm should be analyzed after permanent implant surgery. In the future, a larger, randomized, prospective study should be performed to answer these important questions.
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