Industry Sponsorship Bias in Collagenase Clinical Trials for Dupuytren Disease: A Meta-analysis.

BACKGROUND: Collagenase clostridium histolyticum (collagenase) was introduced in 2010 creating a nonoperative treatment option for Dupuytren disease with promising results in sponsored clinical trials. A meta-analysis was performed to investigate industry sponsorship bias. METHODS: A systematic review of collagenase treatment of Dupuytren contracture was conducted. Articles containing mesh terms including "microbial collagenase" and "Dupuytren's contracture" were searched and limited to only clinical trials with similar protocols for inclusion. Meta-analysis of treatment endpoints of correction of contracture to 0-5 degrees after first and last injection was conducted comparing sponsored versus nonsponsored studies. RESULTS: Sixteen of the 29 identified articles met criteria for inclusion. Nonsponsored studies reported a significantly higher rate of meeting the primary treatment endpoint compared to sponsored studies after single injection for all joints (69.6% vs 56% P < 0.01), metacarpophalangeal joint (96% vs 64% P < 0.01), and proximal interphalangeal joint (67% vs 36% P = 0.011). The correction in contracture rates was similar between groups with studies evaluating more than one injection. CONCLUSIONS: Nonsponsored studies published higher success rates in meeting the primary endpoint of full correction after single injection than sponsored studies; however, similar results with multiple injections. This study demonstrated that sponsored studies of collagenase produced highly powered studies that may be reliably depended on for evidence-based clinical application.

Impact of High-Fidelity Microvascular Surgery Simulation on Resident Training.

BACKGROUND: Microsurgery requires a high level of skill achieved only through repeated practice. With duty-hour restrictions and supervision requirements, trainees require more opportunities for practice outside the operating room. Studies show simulation training improves knowledge and skills. While numerous microvascular simulation models exist, virtually all lack the combination of human tissue and pulsatile flow. METHODS: The authors utilized a novel simulation platform incorporating cryopreserved human vein and a pulsatile flow circuit for microsurgery training at two academic centers. Subjects performed a standardized simulated microvascular anastomosis and repeated this task at subsequent training sessions. Each session was evaluated using pre- and postsimulation surveys, standardized assessment forms, and the time required to complete each anastomosis. Outcomes of interest include change in self-reported confidence scores, skill assessment scores, and time to complete the task. RESULTS: In total, 36 simulation sessions were recorded including 21 first attempts and 15 second attempts. Pre- and postsimulation survey data across multiple attempts demonstrated a statistically significant increase in self-reported confidence scores. Time to complete the simulation and skill assessment scores improved with multiple attempts; however, these findings were not statistically significant. Subjects unanimously reported on postsimulation surveys that the simulation was beneficial in improving their skills and confidence. CONCLUSION: The combination of human tissue and pulsatile flow results in a simulation experience that approaches the level of realism achieved with live animal models. This allows plastic surgery residents to improve microsurgical skills and increase confidence without the need for expensive animal laboratories or any undue risk to patients.

Osteocutaneous Radial Forearm Flap: Harvest Technique and Prophylactic Volar Locked Plating.

Background: The osteocutaneous radial forearm (OCRF) flap is a variation of the traditional radial forearm flap with incorporation of an anterolateral segment of corticocancellous bone of the radius, periosteum, and overlying skin. The OCRF flap is indicated in traumatic injuries or extirpation defects with segmental bone loss and is well suited to foot and ankle reconstruction due to its thin pliable skin. Methods: In this single-center case series, a retrospective review was conducted to identify patients who underwent OCRF free flap for foot and ankle reconstruction that required harvest of more than 50% of the cross-sectional area of the radius with prophylactic volar locked plating of the donor site. Outcome measures included flap failure rates, postoperative fracture, thrombotic events, time to follow-up, and time to full weightbearing. Flap harvest technique is extensively discussed. Results: Six cases were included in this series. There were no flap failures or thrombotic events. Recipient site healing was confirmed in all patients, with partial distal skin paddle loss in one patient requiring operative debridement. No patients sustained donor site complications or functional impairment. Full lower extremity weightbearing was achieved at 12.4 ± 3.3 weeks after surgery. Conclusions: The OCRF free flap transfer provides a reliable means of obtaining thin, supple soft tissue coverage with a large, vascularized segment of bone for reconstruction in the foot and ankle. Here, we describe use of more than 50% of the cross-sectional area of the radius with volar locked prophylactic plating. These updates expand use of this reconstructive technique.

Aesthetic Outcomes of the Adipofascial Turnover Flap for Nasal Defects.

The single-stage adipofascial turnover (AFT) flap with full-thickness skin grafting is a novel technique that has been demonstrated as a safe, reliable, and cost-effective alternative to forehead flaps for nasal tip reconstruction. The purpose of this study was to compare aesthetic outcomes of these reconstructive techniques. Methods: A retrospective review was conducted of patients who underwent either a forehead flap or an AFT flap for nasal reconstruction between January 2016 and January 2021. Aesthetic outcomes were compared via patient surveys and photographic analysis by plastic surgeons. All photographs were standardized and masked to conceal which reconstructive technique was utilized. Wilcoxon rank-sum tests and t-tests were performed to determine significance. Results: Ten forehead flaps and 22 AFT flaps were performed between January 2016 and January 2021. Seven forehead flap patients and 18 AFT flap patients participated in the aesthetic outcome survey. Seven forehead flap postoperative photographs and 20 AFT flap postoperative photographs were available for analysis. Patients who underwent forehead flap reconstruction reported higher satisfaction for color match of the reconstruction to the surrounding nasal skin (P = 0.005). Otherwise, there was no statistical significance between the two patient groups. There was no statistical difference in the photographic analysis of the two groups. Conclusion: The single-stage AFT flap with full thickness skin grafting provides similar aesthetic outcomes compared with the two-stage forehead flap when reconstructing large defects of the nasal tip, which is supported by both patient-reported outcome measures and standardized photographic analysis by a panel of plastic surgeons.

Predictors of Mortality and Revision Following Digital Amputation for Infection and Necrosis.

PURPOSE: Digital amputation is a commonly performed procedure for infection and necrosis in patients with diabetes, peripheral vascular disease (PVD), and on dialysis. There is a lack of data regarding prognosis for revision amputation and mortality following digital amputation in these patients. METHODS: All digital amputations over 10-year period (2008-2018) at a single center were reviewed. There were 484 amputations in 360 patients, among which 358 were performed for trauma (reference sample) and 126 for infection or necrosis (sample of interest). Patient death and revision were determined from National Vital Statistics System and medical records. Propensity score matching was performed to compare groups. Data were then compared to the Social Security Administration Actuarial Life Table for 2015 to determine age-matched expected mortality. RESULTS: The 2-year revision rate was 34% for amputations performed for infection or necrosis, compared to 15% for amputations due to trauma. For amputations performed for infection or necrosis, the revision rate was 47.7% when diabetes, PVD, and dialysis were present. Among all patients with infection or necrosis (n = 104) undergoing a digital amputation, overall survival at 2, 5, and 10 years was 79.4%, 57.3%, and 17.5%, respectively, which represented a 3.2-fold increased risk of death compared to controls. (hazard ratio, 3.19; 95% confidence interval, 1.47-6.93). For amputations due to trauma, mortality was no different from that in the age-matched general population. CONCLUSIONS: Mortality and revision risk are high for patients requiring a digital amputation for infection or necrosis and are further increased with medical comorbidities. Hand surgeons should consider the prognostic implications of these data when counseling patients. TYPE OF STUDY/LEVEL OF EVIDENCE: Prognostic IV.

The Utility of Preoperative HbA1c as a Standardized Protocol in Elective Carpal Tunnel Release: A Retrospective Review of Clinical Outcomes.

Background: In an effort to reduce surgical complications, some institutions have implemented universal hemoglobin A1c (HbA1c) screening for all preoperative patients. However, the value of HbA1c screening for predicting clinically meaningful complications after elective carpal tunnel release (CTR) remains unclear. The purpose of this study was to investigate the clinically meaningful predicative value of HbA1c screening on postoperative complications following elective CTR. Methods: A retrospective cohort study of 790 patients who underwent CTR was performed. All patients had an HbA1c screening performed, regardless of whether they underwent the diagnosis for diabetes or not. Primary outcomes were overall complication rate, rates of major complications (readmission or reoperation), and rates of minor complications (surgical site infection and wound dehiscence). Patients were stratified into 3 groups based on HbA1c: HbA1c <7, HbA1c 7-8, and HbA1c >8. Results: The overall complication rate for all groups was 4.8%. Rates of major complications were 0.4% for readmission and 0.1% for reoperation. For minor complications, the odds ratio (OR) for the HbA1c 7-8 group was 0.6 (95% confidence interval [CI], 0.14-1.77), and for the HbA1c >8 group, the OR was 1.6 (95% CI, 0.66-3.60). All minor complications resolved with outpatient treatment. There were no statistically significant differences between the groups for any comparisons. Conclusions: Elective CTR has a low complication rate. Routine preoperative screening of HbA1c is of little value in predicting clinically meaningful complications.

Single-Stage Adipofascial Turnover Flap as an Alternate Option for Large Nasal Defects Usually Requiring Two-Stage Forehead Flap.

BACKGROUND: Large nasal defects involving the tip, ala, and/or columella with denuded cartilage have traditionally required a two-stage forehead flap. As many Mohs patients are presenting older with increased medical comorbidities, a single-stage adipofascial turnover flap with a full-thickness skin graft was developed by the senior author as an alternative method. The authors hypothesize that the adipofascial turnover flap would have similar success rates and cost less than the forehead flap. METHODS: A retrospective review of all patients in the senior author's practice who underwent either a forehead flap or adipofascial turnover flap between January of 2016 and February of 2019 was conducted. The two groups were compared regarding success, complications, and cost. RESULTS: There were seven forehead flap patients and 11 patients with adipofascial turnover flaps. Overall complications were three of seven (43 percent) for the forehead flap group and one of 11 (9 percent) for the adipofascial turnover flap group. There was one mortality, one revision for asymmetry, and one with airflow obstruction in the forehead group. The adipofascial turnover flap group had one partial skin graft loss that healed with local wound care only. There were no flap failures in either group, and the cost savings averaged over $22,000 in the adipofascial turnover flap group. CONCLUSIONS: The single-stage adipofascial turnover flap with full-thickness skin grafting is a safe, reliable, and less expensive alternate to the forehead flap. The forehead flap will remain a workhorse in nasal reconstruction, but multiple operations increase cost and may contribute to higher complication rates. The adipofascial turnover flap appears to be an efficacious and reasonable option compared with the forehead flap.

Scaphoid overstuffing: the effects of the dimensions of scaphoid reconstruction on scapholunate alignment.

PURPOSE: Osteochondral replacement of the proximal scaphoid has been reported using a vascularized flap from the medial femoral trochlea. A concern with this technique is the loss of stability of the scapholunate relationship with resection of the scaphoid proximal pole. Overexpansion of the scaphoid dimensions (overstuffing) during scaphoid reconstruction with the osteochondral flap may play a role in maintaining scapholunate alignment. Our purpose was to determine if overstuffing the scaphoid can correct rotatory carpal instability in a cadaveric model studied radiographically. METHODS: The radiolunate angle and scapholunate interval were measured for 5 fresh cadaver wrists. We completely incised the scapholunate interosseous ligament and performed an osteotomy to excise the proximal third of the scaphoid to simulate a proximal pole deficiency nonunion and create a dorsal intercalated segmental instability deformity. Radiographic measurements were repeated. The proximal pole of the scaphoid was replaced with its original piece of bone; radiographic measurements were repeated without scapholunate ligament repair. The osteotomy site was overstuffed with a 4-mm sawbone spacer without scapholunate ligament repair, and radiographs were obtained. RESULTS: Sectioning of scapholunate ligaments and proximal pole excision successfully created carpal instability demonstrated by abnormal radiolunate angles. Without ligament repair, proximal pole replacement did not restore normal radiolunate angles. Expansion of the scaphoid dimensions corrected radiolunate angles on lateral unloaded radiographs and improved scapholunate intervals on clenched fist radiographs. These findings were statistically significant compared with the unexpanded (replaced) scaphoid. CONCLUSIONS: These findings suggest that scaphoid reconstruction that results in expansion of the scaphoid's normal dimensions will restore carpal alignment without scapholunate ligament reconstruction. CLINICAL RELEVANCE: Osteochondral reconstruction of difficult proximal pole nonunions may not require any preservation or reconstruction of scapholunate integrity if the reconstruction expands the normal dimensions of the native scaphoid. Scapholunate interval and carpal alignment may be restored by scaphoid over stuffing. The effects on increased contact pressure and range of motion require further investigation.

Evaluation of host tissue integration, revascularization, and cellular infiltration within various dermal substrates.

Acellular dermal matrices are used in a variety of reconstructive and cosmetic procedures. There seems to be host tissue integration, revascularization, and recellularization into these products, but the exact timing and differences among these remain unknown. The purpose of this study is to determine and compare these properties of 4 different acellular dermal matrices (AlloDerm, DermACELL, DermaMatrix, and Integra) in an in vivo rat model. Tissue specimens were obtained at various time points. Histology and immunohistologic assays were used to quantify the extent of cellular infiltration and revascularization within the various matrices. A bimodal cellular response was observed in all products except for DermACELL. Cellular infiltration was highest in DermACELL and lowest in AlloDerm, and angiogenesis was evident by day 7. There were clear differences within the various products. It is undetermined whether these differences are advantageous or clinically significant. Future work is needed to define the specific roles for each.