Surgipro mesh: not all multifilaments are the same.
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Animals↗
Biomedical subjects
George T Rodeheaver
Publications and source records attributed to George T Rodeheaver.
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↗
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↗
Evaluation of an absorbable cyanoacrylate adhesive as a suture line sealant.
BACKGROUND: Previous formulations of cyanoacrylate, though very effective, proved to have too high a tissue reactivity to be used internally. A novel cyanoacrylate compound with less tissue reactivity was recently developed. The objective of this study was to assess this novel cyanoacrylate compound for the use as vascular suture line sealant. MATERIALS AND METHODS: Twelve adult female sheep received a 6 mm PTFE interposition graft in each iliac artery, for a total of 24 grafts. Using oxidized cellulose (Surgicel) as a control, two formulations of a new cyanoacrylate compound (named "compound A" and "compound B") were assessed during this trial. Hemostatic efficiency was measured at the time of operation by the assessment of bleeding time and amount of blood loss. Long-term graft patency was assessed angiographically at 4, 6, and 18 months. Tissue reaction at 2 weeks, 1, 6, and 18 months was assessed grossly by vascular surgeons and microscopically by a blinded pathologist. RESULTS: Average time to hemostasis was 37.6, 50.6, and 219 s in group A, group B, and oxidized cellulose control groups, respectively (P<or=0.001 for both compounds versus control). There were no significant differences between groups with regards to graft patency. Histopathology analysis demonstrated mild to moderate tissue reaction at 2 weeks and 1 month in the cyanoacrylate groups compared with controls at 1 month (ANOVA P=0.004). Mild tissue reaction was seen at 6 months and 18 months, with no significant differences between groups (ANOVA P=0.08, 0.62, respectively). CONCLUSIONS: The novel cyanoacrylate compound examined in this study is a highly effective suture line sealant with only mild tissue reactivity and no significant effects on graft patency when studied over an 18 month period.
Anastomosis, Surgical↗
Octyl 2-cyanoacrylate for repair of peripheral nerve.
The repair of peripheral nerves with sutures is time consuming. The aim of this study was to evaluate the benefits and functional outcome of repairing nerves with octyl 2-cyanoacrylate adhesive. The right peroneal nerve of 64 male, Lewis rats was sectioned and repaired. The rats were randomized into 3 experimental groups: A (n = 27), using only octyl 2-cyanoacrylate; B (n = 27), using 4, 10-0 nylon sutures; and C (n = 10), a sham operation. The recovery of nerve function was quantified through walking-track analyses; group A showed faster return of nerve function than B, especially at 15 days (P < 0.017). Histologic analysis showed a greater axonal regeneration in group A versus group B and no indication of tissue toxicity in group A. No dehiscence occurred during the 6-month study. Use of adhesive shortened the anastomosis time from 12 minutes to 4 minutes. These results indicate that the use of octyl 2-cyanoacrylate adhesive for nerve anastomoses is safe and effective and may have benefits compared with the use of sutures.
Anastomosis, Surgical↗
Use of the PUSH tool to measure venous ulcer healing.
Currently, no instrument is available to provide an accurate and simple method of monitoring venous ulcer healing in clinical practice. The Pressure Ulcer Scale for Healing (PUSH) tool was developed and validated to monitor the healing of pressure ulcers. During a 2-month study involving 27 venous ulcer patients visiting a chronic wound clinic of a major university, the feasibility of using the PUSH tool to monitor healing was evaluated. The patients were assessed by two Wound Ostomy Continence Nurses using the PUSH tool, where 0 = healed and 17 = worst possible score. The mean score at the initial clinic visit was 12. One month and 2 months later, the mean scores were 9 and 8, respectively. Of the 27 participating patients, 23 had a decrease in their PUSH score over the 2-month period of the study; four of the 23 patients had PUSH scores of zero after 2 months because their venous ulcers had healed. One ulcer did not change and three ulcers worsened and their PUSH scores increased. Based on this study, the PUSH tool appears to be an effective way to monitor healing trends in venous ulcers as well as pressure ulcers.
Adult↗
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↗
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↗
Shur-clens: an agent to remove silicone gel after breast implant rupture.
Removal of silicone gel from surrounding tissues after implant rupture is difficult. Local inflammation, infection, and silicone granulomas warrant thorough removal of the silicone gel. Shur-Clens (20% solution of the surfactant poloxamer 188), povidone-iodine, and saline are agents that are used to aid in the removal of silicone gel from tissue. The purpose of this study was to compare the efficacy of silicone gel removal by these three agents in vitro. Shur-Clens, povidone-iodine, and saline were compared as solvents for silicone gel. Four weight increments of silicone gel (0.02 g, 0.04 g, 0.06 g, and 0.08 g) were placed on glass slides. These slides were placed in separate beakers containing 40 ml test solution. The slides were soaked for 1 minute with gentle agitation. The slides were removed, rinsed gently with de-ionized water, and placed in a vacuum desiccator to dry. The slides were weighed to determine the amount of silicone removed after soaking in the solution. Analysis of variance was used to determine the significance between the three solvents. The percentages of silicone gel removed for the four weight increments (0.02 g, 0.04 g, 0.06 g, and 0.08 g) in saline were 5.6%, 2.9%, 2.1%, and 5.8%, respectively. In povidone-iodine solution, the percentages were 18.9%, 25.4%, 28.8%, and 51.9%. In Shur-Clens, the percentages were 31.3%, 43.0%, 63.5%, and 79.9%. The greater percentage of silicone gel removed by Shur-Clens was significant compared with the other solutions (p < or = 0.05). Shur-Clens was shown to be a more effective solvent for removal of silicone gel in vitro. This enhanced efficacy is a result of the fact that Shur-Clens contains 20% of the surfactant poloxamer 188. The authors' clinical experience with 7 patients who underwent ruptured silicone breast implant removal demonstrated the superiority of Shur-Clens. Shur-Clens is a surfactant cleanser that is widely available, is inexpensive, and has a good safety profile. They propose the use of Shur-Clens to clean silicone gel spillage to decrease local complications resulting from residual silicone gel.
Breast↗
An innovative surgical suture and needle evaluation and selection program.
This report describes an innovative suture and needle clinical evaluation program jointly designed by hospital representatives of Consorta, Inc., a healthcare resource management and group purchasing organization, and United States Surgical/Davis & Geck Sutures (USS/D&G), manufacturer of surgical biomaterials. Nineteen Consorta shareholder hospitals enrolled 699 surgeons to participate in Phase I of this nonexperimental observational study of the clinical performance of surgical needles and sutures. Performance characteristics of the sutures and needles produced by USS/D&G, which were evaluated in 3407 surgical procedures, included packaging and ease of opening, needle strength and sharpness, tissue drag, knot security, tensile strength, and clinically acceptable and unacceptable determinations. In these 30-day studies, the surgeons concluded that the needles and sutures were clinically acceptable in 98.1% of the evaluations. The general, cardiothoracic, and orthopedic surgeons, who performed 73.8% of the product evaluations, reported that the suture and needle products were clinically acceptable in 97.2% of the evaluations. More than half (50.1%) of the evaluations involved the POLYSORB* braided synthetic sutures,which received a clinically acceptable rating in 98.4% of the evaluation. The next most frequently used sutures were the SOFSILK*, followed by the monofilament nylon suture. SOFSILK* was found to be clinically acceptable in 98.7% of the evaluations, whereas the monofilament nylon was noted to be clinically acceptable in 96.3% of the evaluations. Surgical needles made by USS/D&G had a 97.9% clinical acceptability rating.
Attitude of Health Personnel↗
The PUSH tool: a survey to determine its perceived usefulness.
OBJECTIVE: To determine the perceived usefulness of the Pressure Ulcer Scale for Healing (PUSH). PARTICIPANTS: A convenience sample identified through the National Pressure Ulcer Advisory Panel Web site as users or registered users of the PUSH tool. MAIN OUTCOME MEASURE: A survey instrument was developed to capture experience, ease of use, and perceived utility and weakness of the PUSH tool. RESULTS: Of 103 respondents, most (79) agreed or strongly agreed that PUSH required an appropriate amount of time to complete. It was also found to be reliable and easy to use and teach to others. Respondents were not as positive regarding usefulness, with 75% indicating that increased PUSH scores prompt patient and treatment reassessment. Respondents agreed or strongly agreed that improvement is possible in the size subscale (59%), the tissue type subscale (49%), and the exudate amount subscale (32%). Most commonly indicated for improvement was the addition of wound depth information. CONCLUSION: Respondents generally found PUSH easy to use and helpful in pressure ulcer management. Specific areas of improvement were also identified.
Attitude of Health Personnel↗