Biomedical subjects

David B Drake

Publications and source records attributed to David B Drake.

11 recordsLinked to original sources

PubMed2006

Syneture stainless STEEL suture. A collective review of its performance in surgical wound closure.

Syneture (division of U.S. Surgical, division of Tyco Healthcare, Norwalk, Connecticut, USA) STEEL sutures are monofilament stainless steel sutures composed of 316L stainless steel conforming to ASTM Standard F138 grade 2 (" Stainless steel bar and wire for surgical implant"). STEEL sutures meet all requirements established by the United States Pharmacopeia (USP) for nonabsorbable surgical sutures. Steel sutures are for use in abdominal wound closure, intestinal anastomosis, hernia repair, sternal closure, and skin closure. They are attached to the following types of surgical needles: Roto-Grip Needles and SCC Needle. The sutures and needles are packaged in a Mylar/Tyvek outer envelope. The purposes of this clinical review are two fold. First, we will report the performance of the Syneture STEEL suture product in the largest studies of suture performance ever reported in the literature. In addition, we will provide comprehensive information from the surgical literature that highlights the unique benefits of stainless steel sutures for the following wound closure techniques: sternal fixation, abdominal wound repair, inguinal hernia repair, and skin wound closure. Consorta Inc. (Rolling Meadows, Illinois), a leading healthcare resource management group purchasing organization, and Syneture, jointly with a clinician task force, designed a reproducible surgical evaluation program for needles and sutures in a large cooperative of healthcare systems. Because of the subjective nature of the more commonly used suture selection techniques, a nonexperimental observational study approach was designed to replace perception of performance characteristics with actual clinical experience. In a report involving 19 Consorta shareholder hospitals, they discussed the preliminary part (Phase I) of a large nonexperimental observational study of the clinical performance of surgical needles and sutures. Performance characteristics of the sutures and needles produced by Syneture that were evaluated in 3407 surgical procedures included packaging/ease of opening, needle strength and sharpness, tissue drag, knot security, tensile strength, clinically acceptable determinations, and clinically unacceptable determinations. In this preliminary study, the surgeons concluded that the needles and sutures were clinically acceptable in 98.1% of the evaluations. Armed with this favorable experience, we wanted to expand this observational study to an entirely new group of shareholder hospitals that had a larger number of participating hospitals (Phase I, 19 hospitals; Phase II, 42 hospitals). This more than doubling of hospital observational base dramatically increased the number of patients and performance evaluations. In the Phase II expanded program involving 42 hospitals, the number of patients (8939) and the number of evaluations (25,545) were more than twofold the preliminary study. In the phase I multicentric evaluation of Syneture surgical sutures, the performance of 9266 sutures was evaluated. Of these performance evaluations, 130 evaluations focused on Syneture STEEL sutures. The surgeons were especially pleased by the performance of this suture product, with 129 Syneture STEEL products being judged as clinically acceptable in their performance. Only one Syneture STEEL suture was judged to be unacceptable in its performance, resulting in a 99.2% acceptability rating. In the expanded phase II evaluation of Syneture suture products, the performance evaluation involved 25,545 surgical suture evaluations. The performance of Syneture STEEL sutures was judged in 215 cases. Of these product performance evaluations, 207 were judged to be clinically acceptable in their performance (96.3%). It is important to emphasize that the phase I and phase II observational studies evaluated the performance of other sutures besides monofilament steel sutures. These comprehensive suture and needle performance evaluations included the following additional sutures: Plain Gut, Mild Chromic Gut, Chromic Gut, DEXON II, DEXON S, MAXON, BIOSYN, SOFSILK, SURGILON, BRALON, MONOSOF, DERMALON, SURGIDAC, POLY-SORB, TI.CRON, SURGIPRO, SURGIPRO II, NOVAFIL, VASCUFIL, and FLEXON. Finally, we provide a collective review of the literature that shows the reliable performance of monofilament stainless steel sutures in the following wound closure techniques: sternal fixation, abdominal wound closure, inguinal hernia repair, and skin wound closure.

Humans↗

PubMed2006

A revolutionary advance in skin closure compared to current methods.

Six pigs were used to evaluate the influence of three separate modalities on contaminated wounds. Full-thickness skin wounds on the abdomen were contaminated with 10(4) or 10(5) Staphylococcus aureus and then closed with one of three methods. The three closure modalities included (1) a new absorbable staple (Insorb) placed in the subcuticular tissue, (2) a braided Vicryl suture, and (3) percutaneous metal staples. Any foreign body material implanted in tissue increases the risk of infection at that site. Wound closure always involves the use of a foreign body. Historically, sutures have been the primary material used to close tissue. The newer synthetic sutures are significangly more biodegradable and cause less infection than sutures composed of protein, such as silk and catgut. Metal staples are also associated with a low risk of infection. Recently, Incisive Surgical, Inc. (Plymouth, Minnesota) has developed an absorbable polymer staple specifically for subcuticular skin closure. The purpose of this study was to compare the new Insorb staple to both an absorbable polymer suture and a metal staple. Wound infection was assessed 7 days after closure by clinical signs and quantitative bacterial swabs. The results demonstrated that wounds closed with Insorb staples had the lowest incidence (33%) of infection, followed by percutaneous metal staples (44%). All wounds (100%) closed with Vicryl suture became infected. The incidence of wound infection directly correlated with the level of quantitative bacterial count at analysis. The Insorb staple was associated with significantly reduced closure time, less inflammation and infection, and better aesthetic result compared to Vicryl. Compared to metal staples, the Insorb subcuticular staplers demonstrated comparable closure time without the need for later staple removal. In conclusion, the closure of contaminated wounds with the Insorb staples is a superior choice to Vicryl suture because they have a significantly (p = 0.009) lower incidence of infection. The Insorb staple is a revolutionary advance in subcuticular skin stapling.

Abdomen↗

PubMed2005

Difficult wounds: an update.

The purpose of this collective review is to describe revolutionary advances in the treatment of Gardner's syndrome (GS), pseudofolliculitis barbae, nasal septal perforation, factitious wounds, and hidradenitis suppurativa (HS). Gardner's syndrome or familial polyposis has various manifestations that appear to be controlled by a single genetic locus. Apart from the large bowel adenomas, which are always present, a common extracolonic symptom of Gardner's syndrome is the occurrence of epidermal cysts. These cysts can be seen before the intestinal polyps are evident. Because epidermal cysts in patients with Gardner's syndrome are always benign, we excise these cysts using incisions that are commonly used for rhytidectomy. Pseudofolliculitis barbae, a pseudofolliculitis caused by ingrown hairs, effects 85% of blacks who shave their beards. When this disease is allowed to progress to keloid formation, we use a surgical approach that includes excision of the keloidal scar, meticulous debridement of all residual ingrown hairs in the underlying wound, and coverage of the defect with a split-thickness skin graft. More recently, laser therapy has revolutionized the treatment of pseudofolliculitis barbae and has enabled a cure for the first time for those plagued with this disorder and for whom a beardless face is acceptable. Nasal septal perforation is a well recognized complication of septal surgery. Other iatrogenic causes of perforation include cryosurgery, electrocoagulation for epitaxis, nasotracheal intubation, or nose packing. In recent years drugs such as cocaine account for an increasing number of perforations. It has only been with the use of an external approach for the repair of the nasal septal defect that surgical closure has become easier and more reliable. The external approach allows for greater surgical closure and enables the surgeon to use both hands with the aid of binocular vision to mobilize and suture local mucosal advancement flaps and the intraseptal connective tissue grafts. More recently, surgeons have repaired large septal perforations with a radial forearm free flap. Because of its availability and deep emotional significance, the skin is a common site for self-destructive behavior with the development of factitious skin wounds. When suspected, psychiatric care must proceed immediately. Second, the ulcer can then be healed by appropriate techniques and wound repair. It is important to emphasize that the treating physician must first confront the patient, and then a psychiatrist should provide appropriate psychotherapy. Hidradenitis suppurativa is an inflammatory disease of the skin and subcutaneous tissue that occurs in apocrine-gland-bearing areas distributed in the axilla, mammary nipple areola, mons pubis, groin, scrotum, perineum, perianal region, and umbilicus. The condition has an insidious onset. The susceptibility of women's axillary skin to hidradenitis suppurativa may be related, in part, to the practice of axillary removal of hair with a safety razor. Consequently, the use of safety razors must be avoided and replaced with the use of an electric razor. The method of treatment will vary with the stage of the disease. Treatment of the chronic stage of axillary hidradenitis suppurativa is primarily surgical. More recently, carbon dioxide laser treatment, with healing by secondary intention, is proving to be a rapid, efficient, and economic treatment of this difficult wound.

Epidermal Cyst↗

PubMed2004

Quantifying bacterial bioburden during negative pressure wound therapy: does the wound VAC enhance bacterial clearance?

The bacterial colonization of a wound is a recognized detrimental factor in the multifactorial process of wound healing. The harmful effects on wound healing are recognized to correspond to a level of > 10(5) colonies of bacteria per gram of tissue. Negative pressure wound therapy has become an accepted treatment modality for acute and chronic wounds with accelerated healing rates observed. It has been previously reported that this therapy enhances bacterial clearance, which may account for the wound healing effects noted. We retrospectively reviewed 25 patients' charts undergoing Wound VAC (Vacuum Assisted Closure Device; KCI International, San Antonio, TX) therapy with serial quantitative cultures and found that there is not a consistent effect of bacterial clearance with the Wound VAC. Furthermore, bacterial colonization increased significantly with Wound VAC therapy and remained in a range of 10(4)-10(6). Despite this finding, the beneficial effects of this treatment modality on wound healing were noted in most cases.

Debridement↗

PubMed2004

Experimental studies in swine for measurement of suture extrusion.

The purpose of this scientific investigation was to identify the determinants of suture extrusion following subcuticular skin closure of dermal skin wounds. Miniature swine were used to develop a model for studying suture extrusion. Standard, full-thickness skin incisions were made on each leg and the abdomen. The wounds were closed with size 4/0 POLYSORB* or COATED VICRYL* sutures. Each incision was closed with five interrupted, subcuticular, vertical loops secured with a surgeon's knot. The loops were secured with 3-throw knots in one pig, 4-throw knots in the second pig, and 5-throw knots in the third pig. The swine model reproduced the human clinical experience and suture extrusion, wound dehiscence, stitch abscess, and granuloma formation were all observed. The cumulative incidence of suture extrusion over 5 weeks ranged from 10 to 33%. COATED VICRYL* sutures had a higher mean cumulative incidence of suture extrusion than that of POLYSORB* sutures (31% vs. 19%). With POLYSORB* sutures, the 5-throw surgeon's knots had a higher cumulative incidence of suture extrusion than the 3-throw or 4-throw surgeon's knot square, 30% vs. 17% and 10%, respectively. This swine model offers an opportunity to study the parameters that influence suture extrusion. Because the volume of suture material in the wound is obviously a critical determinant of suture extrusion, it is imperative that the surgeon construct a knot that fails by breakage, rather than by slippage with the least number of throws. Because both braided absorbable suture materials are constructed with a secure surgical knot that fails only by breakage rather than slippage with a 3-throw surgeon's knot square (2 = 1 = 1), the construction of additional throws with these sutures does not enhance the suture holding capacity but plays a key factor in precipitating suture extrusion. Finally, it is important to emphasize that the surgeon must always construct symmetrical surgical knots for dermal subcuticular skin closure in which the constructed knot is always positioned perpendicular to the linear wound incision. Asymmetrical knot construction for dermal wound closure becomes an obvious invitation for suture extrusion.

Animals↗

PubMed2004

CAPROSYN*, another major advance in synthetic monofilament absorbable suture.

CAPROSYN* suture is the latest innovation in monofilament synthetic suture. This suture is prepared from POLYGLYTONE*6211, a synthetic polyester composed of glycolide, caprolactone, trimethylene carbonate, and lactide. The purpose of this study was to compare the biomechanical performance of CAPROSYN* suture to that of CHROMIC GUT suture. The biomechanical performance studies included quantitative measurements of wound security, strength loss, mass loss, potentiation of infection, tissue drag, knot security, knot rundown, as well as suture stiffness. Both CAPROSYN* and CHROMIC GUT sutures provided comparable resistance to wound disruption. Prior to implantation, suture loops of CAPROSYN* had a significantly greater mean breaking strength than suture loops of CHROMIC GUT. Three weeks after implantation of these absorbable suture loops, the sutures had no appreciable strength. The rate of loss of suture mass of these two sutures was similar. As expected, CHROMIC GUT sutures potentiated significantly more infection than did the CAPROSYN* sutures. The handling properties of the CAPROSYN* sutures were far superior to those of the CHROMIC GUT sutures. The smooth surface of the CAPROSYN* sutures encountered lower drag forces than did the CHROMIC GUT sutures. Furthermore, it was much easier to reposition the CAPROSYN* knotted sutures than the knotted CHROMIC GUT sutures. In the case of CHROMIC GUT sutures, it was not possible to reposition a two-throw granny knot. These biomechanical performance studies demonstrated the superior performance of synthetic CAPROSYN* sutures compared to CHROMIC GUT sutures and provide compelling evidence of why CAPROSYN* sutures are an excellent alternative to CHROMIC GUT sutures.

Absorbable Implants↗

PubMed2003

Hemostatic effect of Vivostat patient-derived fibrin sealant on split-thickness skin graft donor sites.

Topical hemostatic agents are used frequently to control bleeding of skin graft donor sites. In this study, the hemostatic properties of Vivostat (Vivolution A/S, Birkerød, Denmark) patient-derived fibrin sealant were compared with a control group of spray thrombin solution, which is considered an industry standard for topical hemostasis. Treatments were applied simultaneously to two randomly chosen halves of a single split-thickness single donor site in patients in five United States surgical centers. The time to achieve satisfactory hemostasis (< or =10 min) was estimated on each half of the wound as the time at which active bleeding had stopped and the wound was suitable for application of a surgical dressing. The time to hemostasis of wounds treated with Vivostat (Vivolution A/S) patient-derived sealant was significantly shorter in comparison with wounds treated with thrombin solution (medians: Vivostat, 31 seconds; thrombin, 58 seconds; p=0.0012). No abnormalities in wound healing were reported for either treatment site 1 week after the operation. Vivostat (Vivolution A/S) sealant is a more rapidly effective topical hemostatic agent than thrombin on split-thickness skin graft donor sites.

Adult↗

PubMed2003

Surgical management of the hand in Freeman-Sheldon syndrome.

Freeman-Sheldon syndrome is a rare form of distal arthrogryposis characterized by craniofacial anomalies, a rheumatoid-appearing hand, and pedal deformities. The hand deformities include ulnar deviation of the fingers, camptodactyly, first web space contracture, and hypoplasia of the thumb. Because of clinical variability and rarity, there is no standard management protocol. The authors have developed a systematic method of management of the hand in Freeman-Sheldon syndrome using principles commonly applied to other complex hand problems. In 17 years, the authors have evaluated nine patients. Of 18 hands evaluated, the authors have operated on 15. Good results were achieved in five hands and fair results in 10. There were no cases of useless hands. The authors have been most pleased with the results after crossed intrinsic transfers, centralization of extensor tendons, and intrinsic release of the thumb. Although physical deformities remain, functional adaptation is generally good.

Abnormalities, Multiple↗

PubMed2003

Recommendations for postexposure prophylaxis of operating room personnel and patients exposed to bloodborne diseases.

The purpose of this collective review is to discuss management of operating room personnel who have had occupational exposure to blood and other body fluids that might contain hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), and human T-cell lymphotropic virus type I (HTLV-I). HBV postexposure prophylaxis includes starting hepatitis B vaccine series in any susceptible unvaccinated operating room personnel who sustain an exposure to blood or body fluid during surgery. Postexposure prophylaxis with hepatitis B immune globulin (HBIG) is an important consideration after determining the hepatitis B antigen status of the patient. Ideally, all operating room personnel should be vaccinated with hepatitis B vaccine before they pursue their career in surgery. Immune globulin and antiviral agents (e.g., interferon with or without ribavirin) should not be used for postexposure prophylaxis of operating room personnel exposed to patients with HCV; rather, follow-up HCV testing should be initiated to determine if infection develops. Postexposure prophylaxis for HIV involves a basic four-week regimen of two drugs (zidovudine and lamivudine; lamivudine and stavudine; or didanosine and stavudine) for most exposures. An expanded regimen that includes a third drug must be considered for HIV exposures that pose an increased risk for transmission. When developing a postexposure prophylaxis regimen, it is helpful to contact the National Clinicians' Postexposure Prophylaxis Hotline (1-888-448-4911).

Blood-Borne Pathogens↗

PubMed2003

The "open-book" variation of component separation for repair of massive midline abdominal wall hernia.

The reconstruction of massive midline abdominal wall defects as a result of intra-abdominal catastrophes has long challenged the reconstructive surgeon. Previously, the lack of autogenous tissue often forced the surgeon to resort to synthetic materials, which may be complicated by adhesions, enterocutaneous fistulas, and infection. The introduction of the "components of anatomic separation" technique by Ramirez et al. in 1990 allowed for autogenous reconstruction using bipedicle rectus flaps. This technique was far superior to any previous option, but it had its limitations. The authors report a modification to the component separation technique which may allow larger defects to be closed as well as diminish the weakness left below the arcuate line found in some of the previously reported techniques. Ten patients are discussed for which this modified technique of component separation was employed. The follow-up ranges from 5 weeks to 53 months.

Adult↗

PubMed2002

Skin perfusion assessed by contrast ultrasound predicts tissue survival in a free flap model.

The purpose of this study was to assess perfusion in a free skin flap model using contrast-enhanced ultrasound (CEU), and to determine if the extent of perfusion early after venous occlusion predicted long-term flap survival. Perfusion was assessed in an autologous abdominal skin flap and adjacent healthy skin in rats using CEU imaging before venous occlusion and following reflow. Perfusion assessment was possible in all flaps and quantitative measurements of microvascular blood volume (BV) and blood velocity were expressed as a ratio to that in the healthy skin. Proximal flap BV 18 h after venous occlusion was significantly greater in those that survived (n = 4) vs. those that became necrotic (n = 6) (BV ratio 0.8 +/- 0.1 vs. 0.2 +/- 0.1, p = 0.0001). A BV ratio of 0.5 predicted graft viability with a sensitivity and specificity of 100%. Microvascular blood velocity at 18 h was similar in grafts that survived and those that became necrotic. Qualitative assessment of perfusion by a "blinded" observer correlated well with quantitative data and predicted flap outcome in all cases. We conclude that skin perfusion can be assessed with CEU. Perfusion 18 h following a secondary ischemic insult in a free flap accurately predicts subsequent tissue survival in this model.

Abdomen↗