JCM | Free Full-Text | Integra® Dermal Regeneration Template in Complex Scalp Reconstruction

Surgical reconstruction of large scalp defects, most commonly as a result of the excision of cutaneous skin cancers, is a continued challenge to reconstructive surgeons. When evaluating reconstructive options, defects are typically classified as partial thickness or full thickness. Partial thickness defects, which involve the preservation of the pericranium and not amenable to local flap closure, can often be reconstructed using split or full thickness skin grafts. However, full thickness defects pose a greater challenge, and conventional reconstructive options include extensive local flaps, free-tissue transfer or skin grafts with bone burring to stimulate angiogenesis—all of which may not always be feasible in complex cases [1,2]. Donor site morbidity from skin grafts and the difficulties associated with local skin flap closure for specific defects must be carefully considered. Where feasible, it is prudent to opt for the most straightforward approach to achieve a scalp reconstruction that is both functional and aesthetically pleasing, whilst minimising complexity [2]. A particular set of patients pose the greatest challenge in scalp reconstruction, specifically the following: elderly and highly co-morbid patients, those with poor local skin quality, field change unamenable to local skin flaps, full thickness defects with exposed bone, and a potential lack of donor sites for tissue transfer in addition to those who are not fit for general anaesthetic or prolonged procedures.

Originally developed for burn wound coverage, Integra^® is a synthetic acellular dermal regeneration template that promotes revascularisation and connective tissue formation [3]. The emerging use of Integra^® as an adjunct or alternative to skin grafting offers potential solutions to the many challenges in scalp reconstruction, as well as a unique approach to the reconstruction of full thickness defects [4]. Multiple studies have demonstrated the effectiveness of Integra^® in scalp reconstruction [4,5,6], as well as its expanding applications in various anatomical locations. The current literature indicates favourable outcomes and low complication rates associated with the use of Integra^® across different surgical specialties [4,5,6,7,8,9,10,11].

The majority of evidence in the current literature focuses on analysing the outcomes of Integra^® in scalp reconstruction primarily as a two-stage procedure, involving a combination of full and partial thickness defects. This procedure involves the placement of Integra^® immediately following tumour resection, followed shortly thereafter by the placement of a split-thickness skin graft. A study by Tufaro et al. in 2007 demonstrated favourable outcomes with this two-stage technique across various anatomical locations, including in the head and neck, with 94% of patients achieving 100% skin graft uptake [7].

According to the published recommendations from a multidisciplinary advisory board in Italy in 2019, Integra^® is recommended for elderly patients with multiple comorbidities who have a higher risk for potential complications in traditional surgery [8]. Various studies have demonstrated favourable outcomes with the use of Integra^® as a one-stage procedure in the head and neck, both in scalp reconstruction as well as in deep facial defects [9,10,11]. These patients can benefit from reduced anaesthetic risk, reduced operating time, simplified post-surgical care and limited morbidity at the donor site with acceptable functional and aesthetic post-operative results [11].

Outcomes from 101 patients over a 5-year period (January 2018 to December 2022) were retrospectively reviewed. All 101 patients underwent a standard surgical procedure, which involved either primary lesion excision, followed by immediate placement of Integra^®, or solely as a secondary reconstruction procedure whereby Integra^® was being used to reconstruct a pre-existing defect. The Integra^® Dermal Regeneration Template, a two-layer skin regeneration system, was the material of choice used in this study [3]. The procedure was carried out by one of six consultant surgeons within a single department. Following an appropriate oncologically sound surgical excision, a 5–10 mm cuff of peripheral periosteum was left to aid healing. The Integra^® was placed onto the defect and secured on the periphery with sutures. A non-adherent dressing and double layer foam dressing was secured over the Integra^®. Patients were followed up at 1 week post-operatively to review the dressing with dressing removal at 3–4 weeks post-operatively. In the event of suspected infection, broad-spectrum antibiotics according to hospital formulary guidelines were used and then tailored specifically to the patient once microscopy culture and sensitivity results became available.

Scalp reconstruction poses significant challenges, particularly in complex co-morbid patients with advanced-stage cancers and large-sized defects. Integra^® is a dermal regeneration template with emerging use in both clinical practice and the scientific literature for its potential applications in various surgical areas [4]. This retrospective study examines the outcomes and limitations of scalp reconstruction using Integra^® in a cohort of 101 patients. This is the largest cohort of patients who underwent Integra^® reconstruction for scalp defects primarily as a one-stage procedure in the current literature, thus highlighting the versatility of Integra^® usage.

Integra^® demonstrates success in both full and partial thickness defects, even when used without any underlying periosteum, as demonstrated by Singh et al., where it was successfully used to provide soft tissue coverage over a segment of exposed mandible [12]. Furthermore, Integra^® has various applications in other areas of reconstructive surgery, demonstrating success in cases of burns and limb salvage surgery [13]. Additionally, Integra^® can be utilised as a single-stage or a two-stage procedure in conjunction with a split or full thickness skin graft. The majority of existing research focuses on Integra^® when combined with a second-stage skin graft. However, success has been demonstrated in case series by both De Angelis et al. [9] and Koenen et al. [10] on the use of Integra alone to reconstruct both scalp and facial defects without a second-stage skin graft.

With regard the application of Integra^® to scalp reconstruction, Mogedas-Vegara et al. published a study of 70 patients who underwent scalp tumour excision followed by a two-stage reconstruction with Integra^® and a split-thickness skin graft [5]. The study population had an average age of 83.3 years with 92.9% of patients classified as medically comorbid. The mean defect size was 23 cm², with 94% being full thickness defects. The overall success rate was 87.1%, with Integra^® failure in nine patients. Romano et al. published a case series of 20 patients who underwent the same two-stage procedure in 2021 [6]. The median age of their patients was 63 years with a mean defect size of 72 cm². Five of the twenty patients experienced complications, including delayed healing and infection. However, all 20 cases demonstrated skin graft take ranging from 95–100%.

In our study, scalp reconstruction using Integra^® demonstrated high success rates and low complication rates. Our infection rate of 20.8% aligns with the rate reported in Mogedas-Vegara’s study (18.6%), and our overall complication rate of 30.7% is comparable to the rate reported in Romano et al.’s paper (25%). However, these positive outcomes come at the expense of extended healing times and the need for multiple attendances for dressing changes and review. The median time to full healing was 4 months, indicating that patients and healthcare professionals should consider these factors when planning for scalp reconstruction using Integra^®. Using a single-stage technique, scalp reconstruction with Integra^® yielded a positive outcome in 95% of patients, with only five patients requiring a second-stage skin graft procedure either due to ongoing unacceptable bone exposure or impaired healing. Therefore, despite longer healing times, overall patient morbidity is reduced through decreasing the number of clinical procedures required as well as a reduced hospital stay. A 10-year retrospective review of scalp reconstruction by Steiner et al. [14] reported an average post-operative hospital stay of 6.4 days in patients requiring a split-thickness skin graft; however, in our unit, all Integra^® cases are performed as a day case procedure under local anaesthetic. Corradino et al. also performed primary scalp tumour excision and Integra^® placement under a local anaesthetic, with an average operating time of 30.4 min [15]. Although the average operating time was not recorded in our study, the overwhelming majority of procedures were also performed under a local anaesthetic, thus further demonstrating that by avoiding a general anaesthetic, operating times and unnecessary anaesthetic-related complications in an already elderly co-morbid patient group can be reduced.

Of note, Modega et al. [5] commented on seven patients who did not undergo a second-stage split-thickness skin graft due to rapid epithelialisation of the Integra^® graft before the planned second-stage procedure. The authors suggested that a second stage may not always be necessary in some cases, hypothesising that this may be related to smaller defect sizes, as observed in their cases. However, in our study, defect size did not impact complication rates, healing time, or end result. Our data point towards patient factors as having greater significance—a key finding from this study and of importance during surgical planning.

Significantly, there was no notable difference in outcomes between partial and full thickness defects, indicating that Integra^® performs well even when directly applied onto bone. However, an increased depth of defect was found to be a risk factor for requiring a second-stage skin graft. To validate the efficacy of Integra^® use in full thickness defects, the study compared outcomes between the two groups, with no differences in complication rate, healing time, or final outcome identified. As highlighted, in terms of determining the success of scalp reconstruction, patient factors were found to have a greater impact than surgical factors. Most notably, this included associations between previous head and neck radiotherapy with a requirement for second-stage defect, as well as with antithrombotic medication identified as an independent risk factor for developing a complication. Individual patient characteristics appear to play a crucial role in determining the outcome of the procedure, highlighting the importance of personalised treatment approaches. Such an aspect is even more important when considering that this surgical approach may be utilised in the neoadjuvant setting. The emerging use of immunotherapy in select skin cancer patient cohorts, similar to those examined in our study, is an element to consider when planning treatment and assessing the impact of medical comorbidities on surgical outcomes and future treatment, as has been discussed elsewhere [16]—a potential avenue of future research.

Clearly, patient selection is of critical importance and the risk of increased healing time must be weighed against the decreased surgical morbidity of single-stage Integra^® reconstruction, with clear communication of this to the patient, along with informed consent. However, in highly co-morbid patients with extensive lesions or field change unamenable to local skin flaps [9], our evidence is promising for the use of Integra^® and significantly adds to the existing literature. Future research should seek to identify variables for patient selection or modifiable factors that could increase healing time and decrease complication rates in these Integra^®-treated patients. Nevertheless, in a small subset of patients, Integra^® now represents a viable treatment option in previously difficult-to-treat defects.