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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

SBS tissue incorporation: Evaluation of SBS and soft tissue incorporation observed during an elective scar revision of an abdominal donor site 1 year following an SBS onlay reinforcement of a TRAM flap (A). Note that the thickness of tissue was approximately 2–3 mm (B).
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Figure 4: SBS tissue incorporation: Evaluation of SBS and soft tissue incorporation observed during an elective scar revision of an abdominal donor site 1 year following an SBS onlay reinforcement of a TRAM flap (A). Note that the thickness of tissue was approximately 2–3 mm (B).

Mentions: The overall complication rate was 6.5%, which included 2 wound dehiscences (2.6%). Three unplanned reoperations (3.9%) were performed for wound dehiscence, one with device exposure, an infection necessitating explantation (2.4%), and a perioperative bulge (2.4%). Both cases of wound dehiscence occurred in the ventral hernia cohort. The first patient developed a 4-cm skin dehiscence at an inverted T-junction that was treated clinically with dressing changes and healed within 2 weeks. The second wound dehiscence was 6 cm long and also occurred at an inverted T-junction and had an SBS device exposure. The patient was treated with dressing changes and then underwent revisionary surgery with soft-tissue debridement and closure. The SBS device was left in place with no further complications. In a morbidly obese patient, an acute bulge formed during intense coughing on postoperative day 9 following an MS-2 TRAM flap for breast reconstruction. The patient’s abdomen was immediately reexplored, and both the fascial closure and SBS device suture line were found to have dehisced. The abdominal site was repaired with reinset of the SBS device with no further postoperative complications. An infection necessitating explantation was reported in an obese patient undergoing ventral hernia. There were no reports of hernia. Soft-tissue incorporation and vascularization of an SBS device was observed during an elective scar revision of an abdominal donor site at 1 year following an SBS onlay reinforcement of a TRAM flap (Fig. 4).


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)

SBS tissue incorporation: Evaluation of SBS and soft tissue incorporation observed during an elective scar revision of an abdominal donor site 1 year following an SBS onlay reinforcement of a TRAM flap (A). Note that the thickness of tissue was approximately 2–3 mm (B).
© Copyright Policy
Related In: Results  -  Collection

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

Figure 4: SBS tissue incorporation: Evaluation of SBS and soft tissue incorporation observed during an elective scar revision of an abdominal donor site 1 year following an SBS onlay reinforcement of a TRAM flap (A). Note that the thickness of tissue was approximately 2–3 mm (B).
Mentions: The overall complication rate was 6.5%, which included 2 wound dehiscences (2.6%). Three unplanned reoperations (3.9%) were performed for wound dehiscence, one with device exposure, an infection necessitating explantation (2.4%), and a perioperative bulge (2.4%). Both cases of wound dehiscence occurred in the ventral hernia cohort. The first patient developed a 4-cm skin dehiscence at an inverted T-junction that was treated clinically with dressing changes and healed within 2 weeks. The second wound dehiscence was 6 cm long and also occurred at an inverted T-junction and had an SBS device exposure. The patient was treated with dressing changes and then underwent revisionary surgery with soft-tissue debridement and closure. The SBS device was left in place with no further complications. In a morbidly obese patient, an acute bulge formed during intense coughing on postoperative day 9 following an MS-2 TRAM flap for breast reconstruction. The patient’s abdomen was immediately reexplored, and both the fascial closure and SBS device suture line were found to have dehisced. The abdominal site was repaired with reinset of the SBS device with no further postoperative complications. An infection necessitating explantation was reported in an obese patient undergoing ventral hernia. There were no reports of hernia. Soft-tissue incorporation and vascularization of an SBS device was observed during an elective scar revision of an abdominal donor site at 1 year following an SBS onlay reinforcement of a TRAM flap (Fig. 4).

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