The development and prospective clinical evaluation of a new post-surgical dressing for nipple-areola reconstruction surgery
Emma Wilson¹,²
Kathleen Mullinger¹
Lisa Brock¹
Douglas Macmillan¹
1. Nottingham Breast Institute, Nottingham University Hospitals NHS Trust, Nottingham, UK
2. Nottingham Centre for Public Health and Epidemiology, University of Nottingham, Nottingham, UK
Abstract:
Background: Nipple-areola reconstruction surgery is an important oncoplastic breast surgery which has important psychological patient benefits. As with all surgery, nipple-areola reconstruction surgery can present risks including infection and tissue necrosis. Use of effective surgical dressings can improve surgical outcomes and reduce risks.
Aim: An audit of current dressing and patient experience was conducted to inform the development of a new nipple-areola dressing. The dressing was then evaluated in clinical practice.
Evaluation Methods: 23 patients undergoing nipple-areola reconstruction surgery in 2021-2022 at the Nottingham Breast Institute trialled the use of a new dressing: the Advazorb Areola Dressing.
Results: 32 nipple-areola reconstructions in 24 patients were dressed using the Advazorb Areola Dressing. Clinician experience of the dressing was good with 100% of dressings reported to be intact at the 7-day wound follow-up appointment. Patient experience of the dressing was good with all patients reporting the dressing as comfortable to wear. 96% of patients reported the dressing as easy to apply, 100% reported the dressing as easy to remove. 91% of patients reported that the dressing remained waterproof, and 74% reported no skin irritation from using the dressing.
Conclusion: Clinician and patient experience of using the Advazorb Areola Dressing is good and indicates however, clinical effectiveness cannot be determined from this evaluation.
Background
The nipple-areola complex is the primary landmark of the breast and is commonly considered to be the finishing touch to breast-reconstruction survery¹⁻³. Nipple-areola reconstruction surgery is a surgical procedure performed in women who undergo mastectomy and breast reconstruction surgery after breast cancer. It is considered to be an integral part of the breast reconstruction process. Despite being classed as a minor surgical procedure, it holds major significance to the patients⁴ as they report associating this stage with the end of the treatment and a sense of cancer treatment completion⁵,⁶.
Breast reconstruction surgery has a range of different options ranging from implant-based reconstruction to autologous-tissue reconstruction depending on the characteristics of the tumour and patient preference, whereas nipple-areolar reconstruction is generally offered according to patient preference alone regardless of wider clinical and patient circumstances⁶,⁷. This approach is largely because nipple-areola reconstruction surgery is considered to be a relatively simple oncoplastic breast surgery technique, where the patient benefit and psychological impacts are known to be of significant importance to the patient⁵,⁸⁻¹¹. Nipple-areola reconstruction gives an important psychological contribution to breast reconstruction and leads to significantly greater patient outcomes regarding overall satisfaction, sexual behaviour, and satisfaction with aesthetic outcomes because of its overall impact on breast appearance⁵,⁸,¹²⁻¹⁷.
There are various techniques for surgical reconstruction of the nipple-areola complex⁶,¹⁸, and, as with all surgery, there can be post-surgical complications associated with this procedure including tissue necrosis and infection which are elevated with common wider surgical risk-factors such as smoking and obesity¹⁹⁻²⁴.
As nipple-areola reconstruction surgery is considered to be relatively simple and brings significant patient benefit, it is important to ensure good post-operative wound management to promote uncomplicated healing of the nipple-areolar graft.
It is well documented in the literature that inappropriate dressing use and function across all surgical specialities can result in wound disturbance, substandard care, re-admission to theatre, and financial implications for the healthcare system as well as the patients²⁵.
Repeated redressing of wounds can also cause skin trauma and increased suffering for the patient²⁶,²⁷. Ultimately, wound trauma can lead to an increase in wound size, exacerbate pain, delay healing, and increase the chances of infection and skin necrosis associated with poorer overall patient outcomes²⁸.
Selecting and using fit-for-purpose dressing which will support optimal healing progression can increase the likelihood of uncomplicated wound healing and reduce the psychological impacts on patients²⁹.
The aim of this project was to understand the challenges of current dressings used in nipple-areola reconstruction surgery in the Nottingham Breast Institute, to develop a new bespoke dressing for this type of surgery, and then prospectively evaluate the performance and patient acceptability of this new dressing in real-world practice.
This paper describes the development and evaluation of a new bespoke post-surgical dressing for nipple-areolar reconstruction surgery.
Audit of Current Practice:
Clinical Nurse Practitioners in the Nottingham Breast Institute identified, through routine post-operative clinical assessments, that patients were reporting challenges with the post-surgical dressings being used in nipple-areola reconstruction surgery in Nottingham. Based on the patients’ reports, the clinical nurse practitioners conducted an assessment of the types of dressings being used for nipple-areola reconstruction surgery in Nottingham, and in wider surgical units nationally. This was done through direct observations in theatre and post-operative wound clinics and by contacting nurses in other surgical units nationally. These observations and audits were collated in 2019-2020. Additionally, a thorough literature search was conducted using a systematic approach to assess whether any literature exists on other bespoke dressing techniques for nipple-areola reconstruction surgery. One paper was identified which discusses a technique for dressing nipple-areola reconstruction, however, this paper describes creating a dressing from existing surgical dressing materials as opposed to the development of a new bespoke nipple-areola reconstruction dressing²⁹. Following this auditing process, it was determined that there were no specific dressings for nipple-areola reconstruction surgery available. The dressings being routinely used were fashioned from the variety of multi-use standard wound dressings available in theatre and post-operatively. These dressings were noted to be bulky, uncomfortable, non-waterproof, and undignified for patients.
The Clinical Nurse Practitioners in the Nottingham Breast Institute identified a clear gap in the availability of fit-for-purpose wound dressings for nipple-areola reconstruction surgery.
Development of the dressing:
Following the audit information collected; in 2020-2021 Clinical Nurse Practitioners worked with Advancis Medical, UK to develop several protocol dressings which were adjusted in response to informal trial and feedback with patients and clinicians. Following these revisions, the final Advazorb Areola Dressing was developed between Advancis Medical and the Clinical Nurse Practitioners at the Nottingham Breast Institute as acknowledged online by Advancis Medical³⁰.
The new nipple-areola complex reconstruction dressing which was evaluated as part of this study is the Advazorb Areola Dressing by Advancis Medical, product code CR4490. EC Full Quality Assurance System Certificate Number (CE Marked) GB19/964732.00.³⁰
The final product “The Advazorb Areola Dressing” is shown in Figure 1 and Figure 2.
Figure 1 – Diagrammatic representation of The Advazorb Areola Dressing”.
Figure 2 – Photographic representation of The Advazorb Areola Dressing in post-surgical patient use.
Evaluation Aim:
To descriptively and qualitatively evaluate the clinician and patient experience of using the Advazorb Areola Dressing as a novel nipple-areola reconstruction surgical dressing.
Methods:
Following the development and refinement of the Advazorb Areola Dressing between the Nottingham Breast Institute, UK and Advancis Medical UK, an evaluation protocol was developed to explore patient outcomes following Nipple-Areola reconstruction surgery in the Nottingham Breast Institute.
Approval:
Approval for the evaluation of the Advazorb Areola Dressing (a new medical dressing technology) in NHS patients was granted by the Clinical Audit department which is part of the Research and Innovation department at Nottingham University Hospitals NHS Trust. Audit number 18-482H, approved 2020. Additional approvals were not necessary as this product was in the market and CE marked for use in surgical healthcare settings³⁰.
Evaluation Population:
The Nottingham Breast Institute, at the City Hospital Campus, of the Nottingham University Hospitals NHS Trust provides treatment and care for those receiving a diagnosis of breast cancer and benign breast disease. The unit treats approximately 800 breast cancers every year and screens over 35,000 women.
The unit provides reconstructive surgery for patients having breast conservation as well as mastectomy surgery. Pre-pandemic the Nottingham Breast Institute was performing on average 66 nipple-areola reconstructions per year.
Recruitment:
All patients undergoing nipple-areola reconstruction surgery in the Nottingham Breast Institute in 2020-2021 were advised that a new type of dressing would be applied to the surgical site, and that the performance of the new dressing was being evaluated. Patients were asked if they would be willing to complete a questionnaire about the new dressing during their post-operative clinic appointment. Completion of the questionnaires was optional for patients.
Sample:
The original evaluation protocol planned to evaluate 40 consecutive patients who had the Advazorb Areolar Dressing applied in theatre from the 1st of January 2020. The Coronavirus pandemic (March 2020) resulted in prioritisation of urgent cancer surgery and temporary suspension of elective and non-urgent surgery. The evaluation was suspended for 6-months and following the recommencement of surgery, nipple-areola reconstruction surgery was not performed as frequently as pre-pandemic due to long waiting lists for other surgical procedures. As such, the evaluation was terminated early with a total sample of 24 patients having a total of 32 nipple-areola reconstructions.
Data collection:
Basic surgical and patient demographic data was collected from the patients.
Post-operative data was collected from clinicians and patients at the post-operative wound check appointment at approximately day 7 post-surgery.
Clinician data included: qualitative and clinical assessment of dressing longevity, tissue health, evidence of necrosis, infection, dehiscence.
Patient data included: qualitative assessment of ease of application and removal, skin irritation, comfort, dressing longevity and water-resistance.
Data analysis:
Quantitative data points were summarised descriptively using SPSS.
Qualitative free-text responses were synthesised thematically using NVivo.
Results:
Summary of patient characteristics:
Table 1: Summary of patient characteristics included in evaluation.
|
Characteristics |
Number |
|
Number of patients (n) |
24 |
|
Total number of nipple-areola reconstructions (n) |
32 8 bilateral (16 reconstructions) (50%) |
|
Number of patients undergoing nipple-areola reconstruction only (n) |
15 (62%) 7 bilateral (14 reconstructions) |
|
Number of patients undergoing Nipple-Areola Reconstructions performed alongside other surgical procedures (n) |
9 (38%) 1 bilateral (2 reconstructions) |
|
Mean age of patients at the time of surgical procedure (years and range) |
51 (34-69) |
|
Mean number of days between surgery date and wound check date (days and range) |
6 (4-10) |
Clinician reported data:
All data presented are based upon clinical judgment. No formal validated measurement scales of clinical outcomes were used in the clinical assessment of the patients.
Table 2: Summary of clinician-reported evaluation data.
|
Clinician evaluation domain |
Results |
|
Total number of dressings reviewed (n) |
24 |
|
Number of dressings intact at wound check (n) |
32(100%) |
|
Number of healthy nipples at wound check (n) |
30 (94%) 1 left nipple unhealthy No Nipple Dehiscence 1 right nipple unhealthy No Nipple Dehiscence |
|
Number of dressings assessed as easy to apply (n) |
32 (100%) |
|
Number of dressings assessed as having sufficient size nipple hole (n) |
32 (100%) |
Patient reported data:
All data presented are based upon patient self-reported judgment. No formal validated measurement scales of patient outcomes were used in the patient assessment.
Table 3: Summary of patient-reported evaluation data.
|
Patient Evaluation Domain |
Results |
|
Total number of patients completing survey (n) |
24 |
|
Number of patients reporting dressing as comfortable (yes/no) (n) |
Yes: 24 (100%) No: 0 |
|
Number of patients reporting dressing as easy to apply (yes/no) (n) |
Yes: 23 (96%) No: 1 (4%) |
|
Number of patients reporting dressing as easy to remove (yes/no) (n) |
Yes: 23 (100%) No: 0 |
|
Number of patients reporting skin irritation from dressing (yes/no) (n) |
Yes: 6 (26%) No: 17 (74%) |
|
Number of patients reporting dressing remained waterproof (yes/no) (n) |
Yes: 21 (91%) No: 2 (7%) |
|
Number of patients reporting dressing remained in place (yes/no) (n) |
Yes: 32 (100%) No: 0 |
Table 4: Qualitative synthesis of patient-reported themes.
|
Theme |
Example Patient Quotes |
|
Comfort 14 out of 23 patients provided comments under the comfort theme. All comments provided were positive for comfort. |
“Very comfortable and well designed” “Very comfortable and don’t realise you have it on”. “Very comfortable didn’t pull or peel”. “Didn’t know it was there”. “Comfortable and discreet” |
|
Ease of application 6 out of 23 patients provided comments under the ease of application theme. |
“Easier than it looked to apply”. “Easy to apply myself”. “The rigid part of the dressing was difficult to remove when first putting it on” |
|
Ease of removal 6 out of 23 patients provided comments under the ease of removal theme. All comments provided were positive for ease of removal. |
“Very easy, no discomfort” “It didn’t pull”. “Extremely straightforward to remove” |
|
Skin irritation 9 out of 23 patients provided comments under the skin irritation theme. |
“I have sensitive skin and something in the dressing may have irritated”. “Some sweat rash round dressing” “Pink and itchy around the adhesive” “I experienced no irritation and most dressings I have experienced irritation”. “I have sensitive skin and have not had any irritation”. “Really pleased as I previously became allergic to piccline dressings”. |
|
Waterproof 13 out of 23 patients provided comments under the waterproof theme. |
“I had showers but was careful to avoid the area”. “I took extra precautions when showering”. “It remained intact when splashed”. “It didn’t peel off or become soggy”. “Was also sweatproof”. “It got damp when splashed” |
|
Stayed in place 9 out of 23 patients provided comments under the stayed in place theme. |
“It stayed in place even when running”. “Only a small edge of the dressing came unstuck 1-2mm”. “I wore the dressing over a week, and it remained intact”. |
|
Other comments 4 out of 23 patients provided comments under the “other” theme. |
“I was impressed with the dressings and relieved by the ease of use and user friendliness”. “It was 100% improvement on the dressings used for previous surgery”. |
Summary
Discussion:
There is a long-standing awareness of the importance of good wound care across all surgical specialities, including breast surgery.
This evaluation describes the clinician and patient experience of using the Advazorb Areola Dressing for Nipple Reconstruction Surgery in the Nottingham Breast Institute. Both patients and clinicians reported mostly positive experiences with using the dressings, however, only subjective measures were used in this evaluation, and as such objective conclusions cannot be drawn.
There is a clear need for a nipple-areola reconstruction specific dressing which is fit-for-purpose for the surgery type. Overall, the clinician and patient satisfaction for overall healing and experience is good, but as there is no comparator data, it is not possible to conclude an objective improvement in overall clinical outcomes.
The population of patients included in the evaluation included patients who were undergoing only nipple-areola reconstruction surgery and patients who were undergoing nipple-areola reconstruction alongside other breast surgery. There may be differences in the experiences of using the dressings within the different patient groups, and outcomes may be confounded by different surgical procedures and types alongside the nipple-areola reconstruction. There is not sufficient data to be able to delineate this information.
Strengths: This is a simple evaluation of a new dressing which has been explored in a real-world practice-based surgical setting. Patients included in the evaluation were reliably followed-up by the clinical team.
Limitations: The evaluation has a small sample size and there is no data for a comparator group which makes it difficult to assess outcomes compared to standard practice dressings. There is no data available on clinical outcomes for patients who used different dressings. There were no objective clinical outcome or patient-reported outcome measure used in the evaluation. These limitations mean it is difficult to assess anything further than clinician and patient experience.
Recommendations: There is good satisfaction of use from both the clinician and patient experience reported. There is a need for a specific nipple-areola reconstruction dressing which is fit-for-purpose. There were no reports of adverse events with using the Advazorb areola dressing, except for some reports of skin irritation which is possible with all dressing types.
As there are no objective clinical outcomes measured or compared the findings cannot be over-extrapolate to infer clinical significance. However, subjectively, patients and clinicians reported favourable experiences using the dressings within their individual context. Larger scale study and comparison is needed if there is a desire to assess significant clinical effectiveness and cost-effectiveness and no data was collected or tested to support these types of conclusions.
Conclusion:
There is a need for surgical dressings which are fit for purpose for the intended surgery type. Good clinician and patient experiences were reported with using The Advazorb Areola Dressing for Nipple-Areola Reconstruction Surgery in the Nottingham Breast Institute, but clinical effectiveness cannot be determined from this evaluation.
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