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"Pelnac"
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Artificial dermal substitutes for tissue regeneration: comparison of the clinical outcomes and histological findings of two templates
2020
Objective
Artificial dermal substitutes (DSs) are fundamental in physiological wound healing to ensure consistent and enduring wound closure and provide a suitable scaffold to repair tissue. We compared the clinical and histological features of two DSs, Pelnac and Integra, in the treatment of traumatic and iatrogenic skin defects.
Methods
This prospective observational study involved 71 randomly selected patients from our hospital. Wound healing was analyzed using the Wound Surface Area Assessment, the Vancouver Scar Scale, and a visual analog scale. Histological and immunohistochemical evaluations were also performed.
Results
At 2 weeks, greater regeneration with respect to proliferation of the epidermis and renewal of the dermis was observed with Pelnac than with Integra. At 4 weeks, the dermis had regenerated with both DSs. Both templates induced renewed collagen and revascularization. Differences in the Vancouver Scar Scale score were statistically significant at 4 weeks and 1 year. Pelnac produced a significant increase in contraction at 2 weeks with increasing effectiveness at 4 weeks. Integra produced a higher percentage reduction in the wound surface area and a shorter healing time than Pelnac for wounds >1.5 cm deep.
Conclusion
Our observational data indicate that both DSs are effective and applicable in different clinical contexts.
Journal Article
Advancing Fingertip Regeneration: Outcomes from a New Conservative Treatment Protocol
2024
Background Fingertip injuries with volar pulp tissue defects present a significant challenge in management. This study aimed to evaluate the efficacy of a conservative treatment protocol using artificial dermis and semi-occlusive dressings for these injuries. Methods A single-center, prospective study was conducted on 31 patients with fingertip injuries involving volar pulp defects. The treatment protocol included wound debridement, application of artificial dermis (Pelnac®), and a semi-occlusive dressing (IV3000®). The outcomes were assessed using subjective questionnaires and objective measures, including fingerprint regeneration, sensory function, pain, and cosmetic appearance. Results The mean treatment duration was 45.29 days (SD = 17.53). Complications were minimal, with only one case (3.22%) directly attributable to the treatment. Fingerprint regeneration was considerable (mean score = 2.58, SD = 0.67). The sensory disturbances were minimal, with no significant differences across injury types. Post-treatment pain was low (mean = 0.45, SD = 0.67), and cosmetic satisfaction was high (mean = 4.09, SD = 0.94). The overall patient satisfaction was high (mean = 4.41, SD = 0.67), regardless of injury severity. Conclusions The conservative treatment protocol using artificial dermis and semi-occlusive dressings is a promising strategy for managing fingertip injuries with volar pulp defects. This approach minimizes surgical morbidity and achieves excellent functional and aesthetic outcomes.
Journal Article
A novel technique for enhancing the take of Pelnac® dermal substitute in deep dermal burns of the upper limb: a randomized controlled trial
2025
Background
Burn injuries are a major global health concern, especially when large areas of the body are affected, limiting the availability of healthy skin for autologous skin grafting. This makes traditional skin grafting challenging. Skin substitutes have been developed to address these challenges. To date, there is limited research on Pelnac dermal substitute use for treatment of acute deep dermal burn injuries. This study aims to evaluate the effectiveness of Pelnac dermal substitute in treating such injuries on the upper limb.
Methods
This randomized control trial was conducted on 46 cases of acute burn injuries presented to the Kasr Al-Ainy Cairo University Hospital’s burns unit from March 2021 to August 2022. The patients were divided into two groups: the Graft-Only Group, consisting of 23 patients, and the Pelnac Group, comprising 23 patients. The primary outcome was the graft take success rate. The secondary outcomes included scar quality assessment, functional outcomes, and patient satisfaction with aesthetic appearance and functional recovery.
Results
In terms of coverage success, Graft only Group achieved 100% success rate, while Pelnac take was unsuccessful in the first 17 patients. Upon observing the first successful case, we noted that there was no dermis remaining after excision, prompting us to implement more thorough debridement from the outset to reach the subcutaneous fat or fascia. Consequently, the Pelnac coverage was successful in the subsequent four patients, with a 22.7% success rate, (followed by autografting as a second stage). In terms of scar quality improvement, as measured by the Vancouver Scar Scale, the Pelnac group had a significantly lower average VSS value (2.40∓1.52) compared to Graft Only Group (7.45∓1.68) with (P<0.001). Pelnac Group also had significantly higher patient satisfaction with aesthetic appearance compared to the graft-only group (
P
< 0.001). There were no significant differences between the two groups regarding patient satisfaction with functional recovery and the average DASH score (
P
> 0.05).
Conclusions
Pelnac could be regarded as a promising modality for the treatment of acute full thickness burns and can be used in partial thickness burns, specifically in instances of major burns with extensive surface area damage. In these cases, more thorough debridement from the start, reaching a bed of fat or fascia, and then applying Pelnac to increase its take is essential, to serve as a protective cover for the wound bed where it helps to prevent fluid loss and contamination. Level of Evidence: Level I, therapeutic study.
Journal Article
Comparison of Efficacy among Three Dermal Substitutes in the Management of Critical Lower-Limb Wounds: The Largest Biases-Reduced Single-Center Retrospective Cohort Study in Literature
by
Vaienti, Luca
,
Brambilla, Roberto
,
De Francesco, Francesco
in
Aesthetics
,
Bias
,
Cohort analysis
2021
Background and objectives: The skin recently became the main focus of regenerative medicine and, in this context, skin substitutes are fully entering into the plastic surgeon’s armamentarium. Among the various types of skin substitutes, dermal substitutes (DSs) are the most used. Our study aims to retrospectively compare three renowned and extremely similar DS in the management of critical lower limb wounds in the largest cohort analysis currently present in literature. Materials and Methods: We followed a strict protocol of application and evaluation of the DS for each patient and wound and, after a meticulous bias reduction process, we compared final outcomes in terms of efficacy and speed in achieving the defect coverage. Results: Among patients who did not receive a skin graft after the DS, we registered a wound healed surface of 50% for Pelnac, 52% for Integra, and 19% for Nevelia, after 30 days from the external silicon layer removal; among those who received a skin graft after the DS, we observed a significantly lower mean percentage of graft take after 7 days with Pelnac (53%) compared to Integra and Nevelia (92% and 80%, respectively). The overall percentage of wound healed surface obtained after 30 days from the external silicon sheet removal, either with or without skin graft, was 71% for Pelnac, 63% for Integra and 63% for Nevelia. We also ran a sub-group analysis only including grafted wounds with a negative microbiological test and the mean percentage of graft take was similar this time. Eventually, we assessed the influence of the wound’s “chronicity” on its healing, comparing the mean graft take only in “acute” wounds who received a skin graft and it resulted 63% for Pelnac, 91% for Integra and 75% for Nevelia. Conclusions: Integra demonstrates the highest rate of skin graft viability and the highest rate of skin graft takes after 7 days. Pelnac shows the quickest induction of secondary healing in acute wounds. Nevelia is not different from Integra and shows a superior graft take compared to Pelnac, but features the lowest secondary healing induction rate. No differences exist between the three DSs in terms of wound healing after 30 days from the skin graft or from the removal of the external silicon layer.
Journal Article
One-step approach for full-thickness skin defect reconstruction in rats using minced split-thickness skin grafts with Pelnac overlay
by
Zhu, Shihui
,
Liu, Tong
,
Li, Haihang
in
Emergency Medicine
,
Full-thickness skin defect
,
Medicine
2019
Background
Split-thickness skin grafting is the current gold standard for the treatment of traumatic skin loss. However, for patients with extensive burns, split-thickness skin grafting is limited by donor skin availability. Grafting split-thickness skin minced into micrografts increases the expansion ratio but may reduce wound repair quality. Dermal substitutes such as Pelnac can enhance the healing of full-thickness skin wounds, but their application currently requires two surgeries. The present study investigated whether it is possible to repair full-thickness skin defects and improve wound healing quality in a single surgery using Pelnac as an overlay of minced split-thickness skin grafts in a rat model.
Methods
A full-thickness skin defect model was established using male Sprague-Dawley rats of 10 weeks old. The animals were randomly divided into control and experimental groups in which Vaseline gauze and Pelnac, respectively, were overlaid on minced split-thickness skin grafts to repair the defects. Wound healing rate and quality were compared between the two groups. For better illustration of the quality of wound healing, some results were compared with those obtained for normal skin of rats.
Results
We found that using Pelnac as an overlay for minced split-thickness skin grafts accelerated wound closure and stimulated cell proliferation and tissue angiogenesis. In addition, this approach enhanced collagen synthesis and increased the formation of basement membrane and dermis as well as the expression of growth factors related to wound healing while reducing scar formation.
Conclusions
Using minced split-thickness skin grafts overlaid with Pelnac enables the reconstruction of full-thickness skin defects in a single step and can increase the healing rate while improving the quality of wound healing.
Journal Article
Pelnac® artificial dermis assisted by vacuum sealing drainage for treatment of severe avulsion injuries of the fingers
2025
Purpose
This study aimed to evaluate the outcomes of Pelnac assisted by vacuum sealing drainage in managing severe avulsion injuries of the fingers.
Methods
This prospective study was conducted from May 2017 to September 2023, involving 12 consecutive patients with severe avulsion injuries of the fingers. Patients underwent single-stage or two-stage procedures employing Pelnac assisted by vacuum sealing drainage (VSD) for the management of severe avulsion injuries of the fingers. Post-operative follow-up was routinely scheduled, and aesthetic and functional outcomes, sensory recovery, complications were recorded.
Results
Twelve patients were included in the analysis, consisting of 9 males and 3 females, with a mean age of 30.6 ± 11.0 years. All patients presented with severe damage to tendons and deep tissues, as well as varying degrees of bone exposure and injury, with average defect area of 36.9 cm² (range, 11 to 180 cm²). At the final follow-up (mean, 14 months; range, 12 to 29 months), the average score on the Fingertip Injuries Outcome Score (FIOS) was 14.3 (SD 3.9, range 10 to 22), with 6 patients achieving excellent result, 4 classified as good and 2 as fair. Patients reported an average satisfaction score of 74.0 (SD 11.6; range 51 to 94) regarding the aesthetic appearance. The average score on the Vancouver Scar Scale score was 2.3 (SD 2.1, range 1.0 to 7.4). Ten patients reported normal or near-normal sensation, while 2 patients experienced slight sensory loss. The average score on the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire was 13.2 (SD 8.5, range 0 to 47). No infections or hematomas were reported during hospitalization or after discharge.
Conclusion
Pelnac, assisted by VSD, proved to be an effective approach for managing severe avulsion injuries of the fingers. This approach can be considered as a viable alternative for addressing severe injuries or complex wound conditions.
Journal Article
Objective Non-Invasive Bio-Parametric Evaluation of Regenerated Skin: A Comparison of Two Acellular Dermal Substitutes
by
Bulla, Antonio
,
Grieco, Federica
,
Rampazzo, Silvia
in
Analysis
,
Artificial skin
,
Bioengineering
2024
Several dermal substitutes are available on the market, but there is no precise indication that helps surgeons choose the proper one. Few studies have tried to compare different xenogeneic bioengineered products, but no objective bio-parametric comparison has been made yet. Fifteen patients who underwent skin reconstruction with Integra® or Pelnac® were retrospectively evaluated. After at least 12 months of follow-up, an objective and quantitative assessment of several skin biophysical properties, such as color, texture, elasticity, hydration, glossiness and trans-epidermal water loss, were measured with non-invasive skin measurement devices. The grafted skin showed a reduction of the superficial hydration level and a tendency to lower values of trans-epidermal water loss with both dermal substitutes. Melanic and hemoglobin pigmentation were higher in comparison to the donor site in both groups, while a melanic pigmentation increase versus the surrounding skin was seen just with Integra®. Finally, the skin was found to be more elastic when reconstructed with Integra®. The skin barrier appeared to be intact in both groups. Hence, these substitutes are valuable means of skin regeneration. Integra® seems to be more advantageous for reconstructing areas that need more skin flexibility.
Journal Article
Role of a new acellular dermal matrix in a multistep combined treatment of dermatofibrosarcoma protuberans of the lumbar region: a case report
2021
Background
Dermatofibrosarcoma protuberans (DFSP) is a rare skin fibroblastic tumor, with a high rate of recurrence. The treatment of DFSP is generally surgical, and wide local excision is the mainstay of surgical treatment. Therefore, complete assessment of all surgical margins is fundamental before definitive reconstruction. The reconstruction is a challenge for plastic surgeons, especially in particular anatomical areas (for aesthetic or functional problems) or in patients who are not candidates for more complex surgical treatments. We describe an alternative approach for reconstructive treatment of the lumbar area after wide excision of DFSP (without fresh-frozen sections) in a young obese woman with a history of smoking, using a new type of acellular dermal matrix (ADM) in a combined management protocol. The benefits of ADM are numerous: immediate wound closure and prevention of infections and excessive drying; minimal donor site morbidity; and good functional and aesthetic outcomes. Moreover, it is a temporary cover while the anatomical specimen is histologically analyzed, without donor site morbidity or prevention of any future surgery (if the margins are not tumor-free) or radiotherapy.
Case presentation
In October 2019, a 34-year old obese Caucasian Woman with a history of smoking came to our institute for a multinodular growing polypoid mass in her lumbar region. An incisional biopsy diagnosed DFSP. The patient underwent proper staging. A wide local excision with 3 cm clinically healthy tissue margins down to the muscle fascia was performed and the defect was repaired using a combined approach with a new artificial bilaminar dermal template (Pelnac®, Gunze Ltd., Osaka, Japan) and a negative-pressure wound therapy system (V.A.C.®, KCI, San Antonio, USA). After the final histological examination revealed tumor-free margins, a split-thickness graft was harvested from the right gluteus and fixed to the new derma with negative-pressure wound therapy. Postoperative radiotherapy was not necessary. After 15 days, the wound had healed without complications, with satisfactory aesthetic outcome and with no limitation of back motion or pain. After 6 months of follow-up, the patient was free from disease.
Conclusions
This is the first reported case of Pelnac® use in DFSP reconstruction of the lumbar region. We believe that the multistep approach described herein may be a good alternative approach in selected patients with wide resections in particular anatomical areas, especially when frozen sections (with Mohs micrographic surgery) are not available.
Journal Article
The use of dermal regeneration template (Pelnac®) in acute full-thickness wound closure: A case series
2016
Background
Dermal regeneration template (DRT) has been well implicated in the reconstruction of full-thickness burn injury. This case series specifically presents our experience and our clinical application of Pelnac® to achieve wound closure with complex acute full-thickness defect.
Methods
A retrospective review of patients treated with Pelnac for complex wound defects from 2008 to 2014 at Concord Burns Unit was carried out. Variables such as wound aetiology, wound size and complications were considered.
Results
Five patients (four females and one male with a mean age 54 ± 20) all had full-thickness defects (mean defect size 4.3 ± 2.0 % TBSA), some with exposed tendon and bone. The wounds were treated with Pelnac®; the silicone layer was removed at postoperative day 14 and a split-thickness skin graft (0.2 to 0.3 mm) was applied. Clinically, the reconstructed areas demonstrated good granulation tissue at 14 days with good take of the skin graft. There were no major acute graft loss, rejection or associated infection. However, there were small areas of graft loss which did not require re-grafting.
Conclusions
DRT provides a safe and efficacious alternative when dealing with acute contaminated full-thickness wounds. Pelnac® seems versatile in obtaining wound coverage in difficult complex wounds, especially in critically ill patients where free or pedicle flap reconstruction would be problematic.
Level of Evidence: Level V, therapeutic study.
Journal Article
Experience in repair utilizing artificial skin for exposed bone surfaces
2000
PELNAC (Kowa Company, Tokyo, Japan) is an improved artificial skin for grafting, based on that developed by Yannas and Burke in 1980. It consists of two layers of slightly antigenic atelocollagen sponge and silicon film. The repair of exposed bone surface is accomplished by utilizing artificial skin. There have been reports of 13 cases of bone exposure wounds repaired with artificial skin in which secondary skin grafts were accomplished. Eleven of 13 cases were healed, and the method was considered easy and convenient.
Journal Article