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Clinical application of a silk fibroin protein biologic scaffold for abdominal wall fascial reinforcement.

Clemens MW, Downey S, Agullo F, Lehfeldt MR, Kind GM, Palladino H, Marshall D, Jewell ML, Mathur AB, Bengtson BP - Plast Reconstr Surg Glob Open (2014)

Bottom Line: Indications, comorbid conditions, surgical technique, complications, and outcomes were evaluated.Procedures using an SBS included reinforcement of an abdominal-based flap donor site (31.2%), ventral hernia repair (53.2%), and abdominoplasty (15.6%).Procedure-specific outcome studies are warranted to delineate optimal patient selection and define potential device characteristic advantages.

View Article: PubMed Central - PubMed

Affiliation: Department of Plastic Surgery, MD Anderson Cancer Center, The University of Texas, Houston, Tex.; Department of Plastic Surgery, University of Southern California, Keck School of Medicine, Los Angeles, Calif.; Southwest Plastic Surgery, El Paso, Tex.; Paul L. Foster School of Medicine, Texas Tech University Health Sciences Center, El Paso, Tex.; Teleos Plastic Surgery, Pasadena, Calif.; Kind-Chang Plastic Surgery, California-Pacific Medical Center, San Francisco, Calif.; Marshall Cosmétique Center, Miami, Fla.; Division of Plastic Surgery, Oregon Health and Science University, Portland, Ore.; Bengtson Center for Aesthetics and Plastic Surgery, Grand Rapids, Mich.; Michigan State University, Grand Rapids, Mich.

ABSTRACT

Background: Preclinical studies have demonstrated that macroporous silk fibroin protein scaffolds are capable of promoting physiologically durable supportive tissue, which favors application of these engineered tissues for clinical implantation. The safety and effectiveness of a long-lasting, transitory, 510(k)-cleared purified silk fibroin biologic scaffold (SBS) are investigated for soft-tissue support and repair of the abdominal wall.

Methods: We conducted a multicenter retrospective review of all consecutive patients who underwent abdominal wall soft-tissue reinforcement with an SBS device between 2011 and 2013. Indications, comorbid conditions, surgical technique, complications, and outcomes were evaluated.

Results: We reviewed the records of 172 consecutive patients who received an SBS for soft-tissue support. Of those, 77 patients underwent abdominal wall fascial repair, with a mean follow-up of 18.4 ± 7.5 months. Procedures using an SBS included reinforcement of an abdominal-based flap donor site (31.2%), ventral hernia repair (53.2%), and abdominoplasty (15.6%). The overall complication rate was 6.5%, consisting of 2 wound dehiscences, 1 with device exposure, 1 seroma, 1 infection with explantation, and a perioperative bulge requiring reoperation. There were no reports of hernia.

Conclusions: Postoperative complication rates after 18 months were low, and most surgical complications were managed nonoperatively on an outpatient basis without mesh removal. To our knowledge, this is the only series to report on a long-lasting, transitory SBS for abdominal wall repair and reinforcement. Procedure-specific outcome studies are warranted to delineate optimal patient selection and define potential device characteristic advantages.

No MeSH data available.


Related in: MedlinePlus

TRAM flap donor site with mesh interposition reinforcement: Patient was a 64-year-old morbidly obese (BMI, 38) woman (A and B) who presented with recurrent right breast cancer with previous breast-conserving therapy and external-beam radiotherapy to the right chest wall. A right mastectomy was performed with immediate MS-2 free TRAM flap reconstruction and contralateral breast reduction. C, An 8 × 10 cm silk fibroin scaffold was used as an interposition mesh (C) to reinforce complete fascial closure of the abdominal donor site (D). Postoperative course was uncomplicated as seen at 1 year (E and F).
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Figure 2: TRAM flap donor site with mesh interposition reinforcement: Patient was a 64-year-old morbidly obese (BMI, 38) woman (A and B) who presented with recurrent right breast cancer with previous breast-conserving therapy and external-beam radiotherapy to the right chest wall. A right mastectomy was performed with immediate MS-2 free TRAM flap reconstruction and contralateral breast reduction. C, An 8 × 10 cm silk fibroin scaffold was used as an interposition mesh (C) to reinforce complete fascial closure of the abdominal donor site (D). Postoperative course was uncomplicated as seen at 1 year (E and F).

Mentions: Abdominal flap donor-site reinforcement was performed in 24 women with complete fascial closure of the defects (Fig. 2). The patients’ mean age was 54 years (range, 31–64), and their mean body mass index was 30.1 ± 3.6 kg/m2. Soft-tissue flaps raised from the abdomen were classified as DIEP (37.5%), muscle-sparing (MS)-2 TRAM (45.8%), MS-1 TRAM (8.3%), or VRAM (8.3%).41 The type of repair was reported as either interposition (57.1%) or onlay (42.8%) for placement of SBS reinforcement of fascial repair. The mean area of mesh used was 65.8 cm2 (range, 45–70 cm2) for interposition placement and 232.8 cm2 (range, 180–250 cm2) for onlay placement. For abdominal donor sites, all patients received 2 drains that were placed subcutaneously and completely removed at a mean of 10.2 days (SD ± 3.2 days).


Clinical application of a silk fibroin protein biologic scaffold for abdominal wall fascial reinforcement.

Clemens MW, Downey S, Agullo F, Lehfeldt MR, Kind GM, Palladino H, Marshall D, Jewell ML, Mathur AB, Bengtson BP - Plast Reconstr Surg Glob Open (2014)

TRAM flap donor site with mesh interposition reinforcement: Patient was a 64-year-old morbidly obese (BMI, 38) woman (A and B) who presented with recurrent right breast cancer with previous breast-conserving therapy and external-beam radiotherapy to the right chest wall. A right mastectomy was performed with immediate MS-2 free TRAM flap reconstruction and contralateral breast reduction. C, An 8 × 10 cm silk fibroin scaffold was used as an interposition mesh (C) to reinforce complete fascial closure of the abdominal donor site (D). Postoperative course was uncomplicated as seen at 1 year (E and F).
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC4255889&req=5

Figure 2: TRAM flap donor site with mesh interposition reinforcement: Patient was a 64-year-old morbidly obese (BMI, 38) woman (A and B) who presented with recurrent right breast cancer with previous breast-conserving therapy and external-beam radiotherapy to the right chest wall. A right mastectomy was performed with immediate MS-2 free TRAM flap reconstruction and contralateral breast reduction. C, An 8 × 10 cm silk fibroin scaffold was used as an interposition mesh (C) to reinforce complete fascial closure of the abdominal donor site (D). Postoperative course was uncomplicated as seen at 1 year (E and F).
Mentions: Abdominal flap donor-site reinforcement was performed in 24 women with complete fascial closure of the defects (Fig. 2). The patients’ mean age was 54 years (range, 31–64), and their mean body mass index was 30.1 ± 3.6 kg/m2. Soft-tissue flaps raised from the abdomen were classified as DIEP (37.5%), muscle-sparing (MS)-2 TRAM (45.8%), MS-1 TRAM (8.3%), or VRAM (8.3%).41 The type of repair was reported as either interposition (57.1%) or onlay (42.8%) for placement of SBS reinforcement of fascial repair. The mean area of mesh used was 65.8 cm2 (range, 45–70 cm2) for interposition placement and 232.8 cm2 (range, 180–250 cm2) for onlay placement. For abdominal donor sites, all patients received 2 drains that were placed subcutaneously and completely removed at a mean of 10.2 days (SD ± 3.2 days).

Bottom Line: Indications, comorbid conditions, surgical technique, complications, and outcomes were evaluated.Procedures using an SBS included reinforcement of an abdominal-based flap donor site (31.2%), ventral hernia repair (53.2%), and abdominoplasty (15.6%).Procedure-specific outcome studies are warranted to delineate optimal patient selection and define potential device characteristic advantages.

View Article: PubMed Central - PubMed

Affiliation: Department of Plastic Surgery, MD Anderson Cancer Center, The University of Texas, Houston, Tex.; Department of Plastic Surgery, University of Southern California, Keck School of Medicine, Los Angeles, Calif.; Southwest Plastic Surgery, El Paso, Tex.; Paul L. Foster School of Medicine, Texas Tech University Health Sciences Center, El Paso, Tex.; Teleos Plastic Surgery, Pasadena, Calif.; Kind-Chang Plastic Surgery, California-Pacific Medical Center, San Francisco, Calif.; Marshall Cosmétique Center, Miami, Fla.; Division of Plastic Surgery, Oregon Health and Science University, Portland, Ore.; Bengtson Center for Aesthetics and Plastic Surgery, Grand Rapids, Mich.; Michigan State University, Grand Rapids, Mich.

ABSTRACT

Background: Preclinical studies have demonstrated that macroporous silk fibroin protein scaffolds are capable of promoting physiologically durable supportive tissue, which favors application of these engineered tissues for clinical implantation. The safety and effectiveness of a long-lasting, transitory, 510(k)-cleared purified silk fibroin biologic scaffold (SBS) are investigated for soft-tissue support and repair of the abdominal wall.

Methods: We conducted a multicenter retrospective review of all consecutive patients who underwent abdominal wall soft-tissue reinforcement with an SBS device between 2011 and 2013. Indications, comorbid conditions, surgical technique, complications, and outcomes were evaluated.

Results: We reviewed the records of 172 consecutive patients who received an SBS for soft-tissue support. Of those, 77 patients underwent abdominal wall fascial repair, with a mean follow-up of 18.4 ± 7.5 months. Procedures using an SBS included reinforcement of an abdominal-based flap donor site (31.2%), ventral hernia repair (53.2%), and abdominoplasty (15.6%). The overall complication rate was 6.5%, consisting of 2 wound dehiscences, 1 with device exposure, 1 seroma, 1 infection with explantation, and a perioperative bulge requiring reoperation. There were no reports of hernia.

Conclusions: Postoperative complication rates after 18 months were low, and most surgical complications were managed nonoperatively on an outpatient basis without mesh removal. To our knowledge, this is the only series to report on a long-lasting, transitory SBS for abdominal wall repair and reinforcement. Procedure-specific outcome studies are warranted to delineate optimal patient selection and define potential device characteristic advantages.

No MeSH data available.


Related in: MedlinePlus