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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

Ventral hernia with retrorectus mesh reinforcement: Patient was a 58-year-old morbidly obese (body mass index, 42.3) woman with diabetes, history of exploratory laparotomy complicated by peritonitis and abdominal abscesses, and 2 previous ventral hernia repairs now with a 9 cm in width ventral hernia. A and B, Bilateral component separation was performed, followed by creation of the retrorectus plane and closure of the posterior rectus sheath. C, A 10 × 25 cm silk fibroin scaffold was placed for fascial reinforcement (D) followed by complete fascial closure. Postoperative course was uncomplicated as seen at 1 year. E and F, A right latissimus dorsi flap and left mastopexy were performed in the interim for breast cancer.
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Figure 1: Ventral hernia with retrorectus mesh reinforcement: Patient was a 58-year-old morbidly obese (body mass index, 42.3) woman with diabetes, history of exploratory laparotomy complicated by peritonitis and abdominal abscesses, and 2 previous ventral hernia repairs now with a 9 cm in width ventral hernia. A and B, Bilateral component separation was performed, followed by creation of the retrorectus plane and closure of the posterior rectus sheath. C, A 10 × 25 cm silk fibroin scaffold was placed for fascial reinforcement (D) followed by complete fascial closure. Postoperative course was uncomplicated as seen at 1 year. E and F, A right latissimus dorsi flap and left mastopexy were performed in the interim for breast cancer.

Mentions: Ventral hernia repairs were performed in 41 patients (35 women, 6 men) (Fig. 1). The patients’ mean age was 52 years (range, 31–80), and their mean body mass index was 30.8 ± 6.3 kg/m2. Concurrent ostomy placement was reported in 4.9% of patients, and 19.5% had undergone previous ventral hernia repairs. On the basis of Ventral Hernia Working Group recommendations, 80.5% were classified as grade 2, and the remaining 19.5% were classified as grade 3.1 Bilateral component separation was performed in 43.9% of ventral hernias at the discretion of the surgeon. The type of repair was reported as either retrorectus (63.4%) or onlay (36.6%) for placement of SBS reinforcement. The mean area of mesh used was 244.5 cm2 (range, 200–250 cm2). Sixteen patients (39%) underwent postoperative oncologic surveillance with abdominal CT, magnetic resonance imaging, and/or ultrasound. For CT and magnetic resonance imaging evaluations, the SBS device was radiolucent at all time points evaluated. The SBS device was visible on abdominal ultrasound evaluation up to 6 months postoperatively. Patients received 1–4 drains that were placed subcutaneously and completely removed at a mean of 12.7 days [standard deviation (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)

Ventral hernia with retrorectus mesh reinforcement: Patient was a 58-year-old morbidly obese (body mass index, 42.3) woman with diabetes, history of exploratory laparotomy complicated by peritonitis and abdominal abscesses, and 2 previous ventral hernia repairs now with a 9 cm in width ventral hernia. A and B, Bilateral component separation was performed, followed by creation of the retrorectus plane and closure of the posterior rectus sheath. C, A 10 × 25 cm silk fibroin scaffold was placed for fascial reinforcement (D) followed by complete fascial closure. Postoperative course was uncomplicated as seen at 1 year. E and F, A right latissimus dorsi flap and left mastopexy were performed in the interim for breast cancer.
© Copyright Policy
Related In: Results  -  Collection

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

Figure 1: Ventral hernia with retrorectus mesh reinforcement: Patient was a 58-year-old morbidly obese (body mass index, 42.3) woman with diabetes, history of exploratory laparotomy complicated by peritonitis and abdominal abscesses, and 2 previous ventral hernia repairs now with a 9 cm in width ventral hernia. A and B, Bilateral component separation was performed, followed by creation of the retrorectus plane and closure of the posterior rectus sheath. C, A 10 × 25 cm silk fibroin scaffold was placed for fascial reinforcement (D) followed by complete fascial closure. Postoperative course was uncomplicated as seen at 1 year. E and F, A right latissimus dorsi flap and left mastopexy were performed in the interim for breast cancer.
Mentions: Ventral hernia repairs were performed in 41 patients (35 women, 6 men) (Fig. 1). The patients’ mean age was 52 years (range, 31–80), and their mean body mass index was 30.8 ± 6.3 kg/m2. Concurrent ostomy placement was reported in 4.9% of patients, and 19.5% had undergone previous ventral hernia repairs. On the basis of Ventral Hernia Working Group recommendations, 80.5% were classified as grade 2, and the remaining 19.5% were classified as grade 3.1 Bilateral component separation was performed in 43.9% of ventral hernias at the discretion of the surgeon. The type of repair was reported as either retrorectus (63.4%) or onlay (36.6%) for placement of SBS reinforcement. The mean area of mesh used was 244.5 cm2 (range, 200–250 cm2). Sixteen patients (39%) underwent postoperative oncologic surveillance with abdominal CT, magnetic resonance imaging, and/or ultrasound. For CT and magnetic resonance imaging evaluations, the SBS device was radiolucent at all time points evaluated. The SBS device was visible on abdominal ultrasound evaluation up to 6 months postoperatively. Patients received 1–4 drains that were placed subcutaneously and completely removed at a mean of 12.7 days [standard deviation (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