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There is increasing interest in the use of acellular dermal matrices (ADMs) in implant-based breast reconstruction (IBBR). Suggested advantages are that ADMs facilitate one-stage IBBR and improve aesthetic outcomes. We compared immediate one-stage ADM-assisted IBBR with two-stage IBBR (current standard of care). Our previously reported secondary endpoint showed that one-stage ADM-assisted IBBR was associated with significantly more adverse outcomes. Here, we present the primary endpoint results aiming to assess whether one-stage IBBR with ADM provides higher patient-reported quality of life (QOL) compared with two-stage IBBR. This multicentre, open-label, randomised controlled trial (BRIOS study) was done in eight hospitals in the Netherlands. We recruited women aged older than 18 years with breast carcinoma or a genetic predisposition who intended to undergo skin-sparing mastectomy and immediate IBBR. Participants were randomly assigned to undergo one-stage IBBR with ADM (Strattice, LifeCell, Branchburg, NJ, USA) or two-stage IBBR. Randomisation was stratified by centre and indication for surgery (oncological or prophylactic) in blocks of ten participants. The primary endpoint was patient-reported QOL, as measured with the BREAST-Q (ie, health-related QOL scales and satisfaction scales), in the modified intention-to-treat population. The study follow-up is complete. This study is registered with the Netherlands Trial Register, number NTR5446. Between April 14, 2013, and May 29, 2015, we enrolled 142 women, of whom 69 were randomly assigned to receive one-stage ADM-assisted IBBR and 73 to receive two-stage IBBR. After exclusions, the modified intention-to-treat population comprised 60 patients in the one-stage group and 61 patients in the two-stage group. Of these, 48 women (mean follow-up 17·0 months [SD 7·8]) in the one-stage group and 44 women (17·2 months [SD 6·7]) in the two-stage group completed the BREAST-Q at least 1 year after implant placement. We found no significant differences in postoperative patient-reported QOL domains, including physical wellbeing (one-stage mean 78·0 [SD 14·1] vs two-stage 79·3 [12·2], p=0·60), psychosocial wellbeing (72·6 [17·3] vs 72·8 [19·6], p=0·95), and sexual wellbeing (58·0 [17·0] vs 57·1 [19·5], p=0·82), or in the patient-reported satisfaction domains: satisfaction with breasts (63·4 [15·8] vs 60·3 [15·4], p=0·35) and satisfaction with outcome (72·8 [19·1] vs 67·8 [16·3], p=0·19). Taken together with our previously published findings, one-stage IBBR with ADM does not yield superior results in terms of patient-reported QOL compared with two-stage IBBR. Risks for adverse outcomes were significantly higher in the one-stage ADM group. Use of ADM for one-stage IBBM should be considered on a case-by-case basis. Pink Ribbon, Nuts-Ohra, and LifeCell.

To compare the outcomes of augmentation urethroplasty (AU) performed with either buccal mucosa graft (BMG) or penile skin graft (PSG) in managing long-segment anterior urethral strictures. A prospective randomized trial involved 98 patients diagnosed with anterior urethral stricture scheduled to AU between June 2022 and December 2024. Participants were randomly assigned to either the PSG or BMG arms. The comparison included patient demographics, clinicopathological characteristics of strictures, and surgical outcomes. The primary outcome was the success rate at 12 months. Secondary outcomes included functional parameters, such as the Urethral Stricture Surgery-Patient Related Outcome Measure (USS-PROM), the International Prostate Symptom Score (IPSS), the International Index of Erectile Function (IIEF) Score, the Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EJD), Q-max, and perioperative complications. The study arms were comparable regarding the preoperative parameters with a mean stricture length ± SD of 6.4 ± 2.3 and 7.9 ± 4.1 cm for PSG and BMG, respectively ( p  = 0.11). After a median follow-up of 20 months (12–30), the success rates of AU with PSG and BMG were comparable (93.2% v/s 97.9%, respectively; p  = 0.346). There was no statistically significant difference in the IIEF ( p  = 0.8) and MSHQ-EJD ( p  = 0.22). The improvements in USS-PROM: LUTS domain ( p  = 0.19), USS-PROM: peeling voiding score ( p  = 0.62), IPSS ( p  = 0.43), and Q-max ( p  = 0.39) were comparable between the study arms. Clavien–Dindo grade I-III complications were 6.8 and 8.3% ( p  = 0.8), with patients’ satisfaction of 90.9% and 93.8% ( p  = 0.5) for PSG and BMG, respectively. Kaplan–Meier survival analysis showed no statistically significant difference in stricture-free survival among both techniques (hazard ratio 1.19; p  = 0.275). Our study demonstrates that PSG and BMG techniques for augmentation anterior urethroplasty have high and comparable success rates, with equal patient satisfaction and similarly low morbidity. Neither technique negatively affected sexual or ejaculatory functions.

Acellular dermal matrix (ADM) has been widely used in skin grafting to provide a dermal layer for facilitating graft take and mature scarring. This randomized controlled, double-blinded superiority study aimed to quantitatively assess the effects of this technique on the resulting graft sites via functional measurements including elasticity, humidification, transepidermal water loss (TEWL), pigmentation, and erythema at 6 months after surgery. A survey was performed to evaluate the satisfaction levels of both patients and surgeons. We considered patients with full-thickness skin defects for whom split-thickness skin grafts (STSGs) were used. By random assignment, they were allocated to the ADM group or the STSG-only group. The ADM group received STSG with a ADM layer on the defect, whereas the STSG-only group was reconstructed with only STSG. At 6 months after surgery, patients were evaluated for elasticity, humidification, TEWL, erythema, and pigmentation. Defect areas before and 2 weeks after surgery were traced and measured. Patients and surgeons rated the graft sites as excellent, good, fair or poor at 6 months after the operation. Among the 89 patients who were screened, 54 patients were enrolled in this study. Compared with those in the STSG-only group, defects that were reconstructed with STSG and ADM resulted in significantly greater elasticity, lower TEWL, and less erythema. There were no significant differences in humidification or pigmentation. The ADM co-grafted with STSGs was associated with greater satisfaction among surgeons, whereas patient satisfaction was not significantly different between the two groups. Co-grafting ADM with STSG in full-thickness wounds can lead to favorable wound healing in terms of elasticity, TEWL, and erythema. This approach also has a higher satisfaction rate for surgeons. Registry: Clinical Research Information Service ( https://cris.nih.go.kr ), Registration number: KCT0007040, Registration date: 24/02/2022.

Autologous split thickness skin grafting is the standard-of-care for most deep dermal and full thickness skin defects. Historically, mesh grafting is used to expand skin grafts for smaller defects and other techniques such as Meek micrografting is used to enable expansion for larger skin defects. Yet, Meek micrografting is increasingly used for smaller skin defects as well. Both techniques are frequently used, especially in burn centers, but evidence on which one is preferable for relative smaller skin defects is lacking. Therefore, an intra-patient randomized controlled trial was designed to adequately compare multiple outcomes of the Meek micrografting and mesh grafting techniques. A multicenter intra-patient controlled randomized trial is being performed in two burn centers (the Netherlands and Belgium) to compare multiple outcomes of Meek micrografting and mesh grafting burns or skin defects. Study registration number (NL74274.029.20). Adult patients with a (burn) wound and an indication for surgical excision and skin grafting were screened for inclusion. In total 70 patients will be included and the primary outcome is scar quality twelve months post-surgery assessed by the Patient and Observer Scar Assessment Scale. Moreover, graft take, re-epithelialization, infection rate, donor site size and patients' preference are also measured within hospital admission, on 3 months and 12 months post-surgery. This is the first randomized trial that is intra-patient controlled, which enables a proper comparison between both skin expansion techniques. The results of this study will contribute to the clarification of the indications of both techniques and ample attention is paid for the patients' opinion on the surgical treatment options.

Follicular cell suspension (FCS) transplantation is a novel surgical method for treating resistant stable vitiligo, whereas mini punch grafting is an established effective method for treating stable vitiligo. The combination of FCS and mini punch grafting is a better strategy for the treatment of resistant stable vitiligo. The aim of the study was to evaluate the efficacy of follicular cell suspension, mini punch grafting, and a combination of both techniques in the treatment of stable vitiligo. This prospective comparative study was conducted on 48 patients with stable vitiligo. They were divided into three equal groups, including group A (treated with follicular cell suspension), group B (treated with mini punch grafting), and group C (treated with the combination of both techniques). All patients were followed-up for six months for the assessment of their therapeutic response regarding clinical outcomes. By comparing the data of the three studied groups, we found that the difference in the degree of re-pigmentation after one and three months of treatment was not significant. However, the progress of re-pigmentation was significantly different after six months of treatment among the three studied groups ( P  = 0.027). Specifically, re-pigmentation was significantly better in group C than in groups A and B ( P  = 0.037 and 0.017, respectively), but it was not significantly different between groups A and B.

All wounds that cannot be closed primarily needs skin coverage earliest to prevent form infections. Skin graft provides earliest and easiest wound coverage, but produces another wound, i.e. donor site wound. This study was conducted to see healing time efficacy in donor site wounds. Study was designed as prospective and randomized control study, in the Department of Plastic and Reconstructive Surgery at Civil Hospital Karachi, included 60 patients who underwent split thickness skin grafting. From the next day of surgery heparin and conventional dressings groups were made and dressing was done daily till seventh postoperative day. Data in form of questionnaire and photographs were recorded. This study was a self-controlled trial, therefore every trial participant served as his/her own control. The results of the analysis showed a decrease in soakage of dressing and a reduction in itching at intervention site. In regard to wound size, 40% of participants showed a reduction in wound size and only 20% showed no improvement at interventional half. During 7days, 81.67% of participants showed improvement in edema at intervention half. The study showed heparin irrigation resulted in better wound healing by reducing pain, edema, faster healing and reducing soakage of dressings. Trial registration The study was approved by Institutional Review Board of Dow University of Health Sciences and was registered at Clinical Trials.gov (ID NCT04613336) on 13/07/2021.

Standard treatment for large burns is transplantation with meshed split skin autografts (SSGs). A disadvantage of this treatment is that healing is accompanied by scar formation. Application of autologous epidermal cells (keratinocytes and melanocytes) may be a suitable therapeutic alternative, since this may enhance wound closure and improve scar quality. A prospective, multicenter randomized clinical trial was performed in 40 adult patients with acute full thickness burns. On two comparable wound areas, conventional treatment with SSGs was compared to an experimental treatment consisting of SSGs in combination with cultured autologous epidermal cells (ECs) seeded in a collagen carrier. The primary outcome measure was wound closure after 5–7 days. Secondary outcomes were safety aspects and scar quality measured by graft take, scar score (POSAS), skin colorimeter (DermaSpectrometer®) and elasticity (Cutometer®). Wound epithelialization after 5–7 days was significantly better for the experimental treatment (71%) compared to the standard treatment (67%) (p = 0.034, Wilcoxon), whereas the take rates of the grafts were similar. No related adverse events were recorded. Scar quality was evaluated at 3 (n = 33) and 12 (n = 28) months. The POSAS of the observer after 3 and 12 months and of the patient after 12 months were significantly better for the experimental area. Improvements between 12% and 23% (p ≤ 0.010, Wilcoxon) were detected for redness, pigmentation, thickness, relief, and pliability. Melanin index at 3 and 12 months and erythema index at 12 months were closer to normal skin for the experimental treatment than for conventional treatment (p ≤ 0.025 paired samples t-test). Skin elasticity showed significantly higher elasticity (p = 0.030) in the experimental area at 3 months follow-up. We showed a safe application and significant improvements of wound healing and scar quality in burn patients after treatment with ECs versus SSGs only. The relevance of cultured autologous cells in treatment of extensive burns is supported by our current findings.

To investigate if donor and recipient site morbidity (healing time and cosmesis) could be reduced by a novel, modified split-thickness skin grafting (STSG) technique using a dermal component in the STSG procedure (DG). The STSG technique has been used for 150 years in surgery with limited improvements. Its drawbacks are well known and relate to donor site morbidity and recipient site cosmetic shortcomings (especially mesh patterns, wound contracture, and scarring). The Dermal graft technique (DG) has emerged as an interesting alternative, which reduces donor site morbidity, increases graft yield, and has the potential to avoid the mesh procedure in the STSG procedure due to its elastic properties. A prospective, dual-centre, intra-individual controlled comparison study. Twenty-one patients received both an unmeshed dermis graft and a regular 1:1.5 meshed STSG. Aesthetic and scar assessments were done using The Patient and Observer Scar Assessment Scale (POSAS) and a Cutometer Dual MPA 580 on both donor and recipient sites. These were also examined histologically for remodelling and scar formation. Dermal graft donor sites and the STSG donor sites healed in 8 and 14 days, respectively ( p  < 0.005). Patient-reported POSAS showed better values for colour for all three measurements, i.e., 3, 6, and 12 months, and the observers rated both vascularity and pigmentation better on these occasions ( p  < 0.01). At the recipient site, (n = 21) the mesh patterns were avoided as the DG covered the donor site due to its elastic properties and rendered the meshing procedure unnecessary. Scar formation was seen at the dermal donor and recipient sites after 6 months as in the standard scar healing process. The dermis graft technique, besides potentially rendering a larger graft yield, reduced donor site morbidity, as it healed faster than the standard STSG. Due to its elastic properties, the DG procedure eliminated the meshing requirement (when compared to a 1:1.5 meshed STSG). This promising outcome presented for the DG technique needs to be further explored, especially regarding the elasticity of the dermal graft and its ability to reduce mesh patterns. Trial registration : ClinicalTrials.gov Identifier (NCT05189743) 12/01/2022.

Background Burn wounds are commonly encountered in clinical settings and the management aims at the prevention of mortality and morbidity due to disability. The platelet-rich plasma (PRP) is blood-derived biomaterial that is enriched with growth factors and cytokines that facilitate wound healing. The PRP has proven its efficacy in various other wounds, but its role in post-burn raw areas and graft take has not been validated. This proposed multicentre randomized controlled trial aims to evaluate the efficacy and safety of platelet-rich plasma as an adjunct therapy to split-thickness skin graft in burn patients with granulating raw wounds. Method/design This trial is an investigator-initiated, double-blind multicentre, randomized controlled parallel arm trial alongside trial cost-effectiveness analysis. Granulating deep second-degree and third-degree burns affecting 3–20% of total body surface area (TBSA) at 10–14th post-burn day will be included in the study. A total of 550 patients (275 in each group) will be randomized to receive either standard skin graft or allogenic PRP with skin graft treatment. The primary endpoint will be the mean percentage of graft-take on the 14th postoperative day. The result will be analyzed by two independent assessors who are blinded to the study. Secondary endpoints include (a) time taken for complete wound healing; (b) frequency of adverse events; (c) follow-up with scar index at 3 months, 6 months, and 1 year using the Patient and Observer Scar Assessment Scale (POSAS) score; (d) cost-effectiveness analysis of the intervention compared to the comparator; and (e) to estimate in a subset of participants the association between growth factor levels (PDGF BB and TGF ß-1) of activated PRP and clinical response. Discussion The proposed trial will be expected to verify the efficacy and safety of PRP for split-thickness skin graft (STSG) in deep second-degree or third-degree granulating wounds of burn patients based on the outcome of the study.

Full‐thickness skin graft (FTSG) reconstructions of lower limbs are especially prone to wound complications. Negative pressure wound therapy (NPWT) enhances wound healing, but no broad evidence exists if it promotes graft take of lower leg FTSGs. In this investigator‐initiated, prospective, randomised and controlled trial, 20 patients with ambulatory FTSG reconstruction for lower limb skin cancers were randomised for postoperative treatment with either NPWT, or conventional dressings. As outcomes, adherence of the skin graft 1 week postoperatively, any wound complications within 3 months, including ≥3 weeks delayed wound healing, and the number of additional postoperative visits were compared. In both groups, grafts adhered equally well (p = 0.47); 80% of NPWT‐treated and 100% of control group grafts adhered >90%. There was no significant difference in the number of postoperative complications/delayed wound healing (p = 0.65); 70% of patients in the NPWT and 50% in the control group developed a wound complication. Both groups had an equal number of patients with at least three additional control visits (p = 1.0). The study was discontinued after 20 patients were recruited, as no benefit from NPWT was seen. To conclude, the study showed no benefit from NPWT for lower limb FTSGs.