Pilot Study: Prospective, First-in-human Clinical Evaluation of a Novel Tissue Apposition Device (ENIVO) Following Simple Unilateral Mastectomy

Abstract

Background:

Surgery resulting in tissue removal and the formation of dead space is traditionally managed with surgical drains. Drains are used to reduce fluid accumulation and decrease the risk of infection, dehiscence, and seroma formation. However, drains do not actively appose adjacent tissue planes to address dead space. A first-in-human clinical study was undertaken following simple unilateral mastectomy using a novel tissue apposition device.

Methods:

This prospective pilot study collected data on 10 participants undergoing simple unilateral mastectomy who would otherwise have received standard surgical drains as part of postoperative management. Participants were instead managed with a pulsed air closure technology (PACT) device designed to remove fluid and to appose adjacent tissue planes of the excisional site. Participants were monitored for complications, fluid output, and fluid accumulation, with a 3-month follow-up.

Results:

The mean tissue excised was 793.7 ± 353.9 g. The PACT device removed a mean cumulative fluid volume of 306.2 ± 163.7 mL during a mean treatment duration of 6.5 ± 1.5 days. Ultrasound assessment, at approximately 14 days postoperatively, estimated a median fluid accumulation of 6.9 mL (interquartile range: 0.0–66.2 mL) at the treatment site. Minor complications included exit site bruising, erythema before drainage catheter removal, and a single resolving superficial infection. Only 1 participant developed a seroma requiring clinical intervention.

Conclusions:

The PACT device performed its intended function in simple unilateral mastectomies. Minor complications were similar to those observed with traditional surgical drains and all resolved by the 3-month follow-up. These findings warrant further investigation in larger cohorts and in additional surgical applications.

Takeaways

Question: Can a powered vacuum catheter device provide safe tissue apposition to support dead space management?

Findings: A novel tissue apposition device was assessed in a pilot study, where the device was deployed after mastectomy to manage dead space and fluid accumulation. The device was found to be safe in the limited pilot study.

Meaning: This first-in-human pilot study has demonstrated that the novel tissue apposition device is safe, using a small patient sample. Further safety and efficacy studies are warranted.

INTRODUCTION

Surgical tissue resections, reconstructions, and trauma can result in significant dead space between tissue layers. Localized fluids, including plasma, blood, and lymph, can accumulate between these layers and fascial planes, resulting in the formation of seromas or hematomas.^1,2 The fluid collections can act as a reservoir or nidus for infection, contribute to surgical wound dehiscence, and act as an impediment to staged procedures or planned reconstructions.³ When fluid accumulations result in superficial and deep surgical site infections, not only is morbidity increased but hospital stay and incurred treatment costs to the healthcare system and patient are increased.^4–6 In the case of mastectomy, seroma may delay chest wall radiation therapy.⁷ To mitigate these known risks, surgical drains are often placed to remove excess fluid accumulating at the surgical site, a practice that is commonplace in mastectomy.⁸ Multiple commercially available surgical drains exist to create a gravity or negative pressure gradient to remove fluid and prevent the formation of seromas or hematomas. Common systems include negative pressure created by suction bulbs (eg, Jackson-Pratt, Cardinal Health) and mechanical spring-loaded devices (eg, Hemovac, Zimmer Biomet).

Despite widespread use, surgical drains present common challenges. Blockage of the tubing system can prevent adequate flow of fluid, causing obstruction secondary to adipose tissue and fibrinous clots. This is particularly of concern in surgical interventions that result in a large disruption of adipose tissue, such as in mastectomy, reconstructions, and flaps, or in orthopedic surgery involving significant soft tissue damage or separation. An additional concern arises if the drain is unable to remove a significant volume of postsurgical fluid contributing to delayed wound healing or dehiscence.⁹ Furthermore, even when surgical drains are working to remove fluid adequately, current systems do not directly address tissue apposition and closure of dead space. There are a large number of different techniques used in attempts to address the challenge of dead space management, including retention and quilting suture techniques,^10,11 diligent closure of fascial planes, flap fixation,¹² and fibrin adhesives.^13,14 However, none of these are fully effective at mitigating dead space and fluid accumulation, and dead space management remains a challenge to surgeons.

To address these challenges, a novel surgical device was developed that combines a biological decellularized extracellular matrix (dECM) graft fitted to a dual lumen drainage catheter, connected to a battery-powered pulsed air closure technology (PACT) device.¹⁵ The PACT device (ENIVO; Aroa Biosurgery Limited, Auckland, New Zealand) provides electronically controlled subcutaneous negative pressure suction, concomitant pulsed air to eliminate drain blockage, and a dECM sleeve that augments tissue apposition via tissue integration. Mason et al¹⁵ provided a detailed description of the PACT device. The dECM bioscaffold component comprises ovine forestomach matrix (OFM), a widely used material for soft tissue repair and reconstruction.^16–21 The comparative performance of the PACT device has previously been investigated in an ovine (sheep) animal model of tissue apposition.¹⁵ Using this model, large soft tissue defects were created in the external abdominal oblique musculature. Fluid accumulation and seroma formation were assessed in defects treated with either the PACT device or a standard-of-care surgical drain. This in vivo study demonstrated that the accumulation of subcutaneous fluid was significantly lower in defects treated with the PACT device compared with defects treated with a standard surgical drain. Additionally, at final necroscopy, defects treated with the PACT device demonstrated a greater degree of tissue apposition as the OFM sleeve had integrated into the apposing tissue planes as designed.

The demonstrated efficacy of the PACT device in a large animal model of surgical dead space formed the basis for the present study, a prospective pilot study investigating the safety of the PACT device in patients undergoing simple unilateral mastectomy.

METHODS

The study was approved by the Southern Health and Disability Ethics Committee, Ministry of Health (Wellington, New Zealand) (reference no.: 2023 AM 13814) and conducted in accordance with the Declaration of Helsinki. De-identified patient data were collected from 10 participants between July 2023 and July 2024 at 2 sites according to the inclusion and exclusion criteria (Table 1). The primary study end point was the frequency of device-related adverse events. Secondary end points included daily fluid collection volume and cumulative fluid collection volume, mean time (in days) to drainage catheter removal, frequency of surgical site occurrences (SSOs) (defined as seroma, hematoma, minor infection [cellulitis], major infection [defined as requiring additional or a change in antibiotic usage, and/or surgical intervention], skin necrosis/dehiscence, any surgical intervention, or other complication) before long-term follow-up (3 mo), postoperative pain (visual analog scale score 0–10), and length of stay. Statistical analysis, including descriptive statistics (eg, mean, standard error of the mean), was conducted using GraphPad Prism (Version 9.3.0, GraphPad Software LLC).

Table 1.

Inclusion and Exclusion Criteria

Inclusion Criteria

Exclusion Criteria

• Willing and able to provide written informed consent • Aged ≥21 y • Undergoing simple unilateral mastectomy, with or without sentinel node biopsy and who would otherwise be receiving surgical drains as part of standard of care • Received PACT device

• Patients with known sensitivity to ovine (sheep)-derived material, silicon, barium sulfate, or synthetic suture materials • Pregnant or lactating women • Patients on steroids or other immune modulators known to impact healing • Patients who are likely to not complete the study • Patients who, in the opinion of the investigator, are unlikely to comply with the protocol • Patients who have participated in this trial previously and who were withdrawn • Any medical condition, recent treatment, or serious intercurrent illness that, in the opinion of the investigator, may make it undesirable for the patient to participate in the study, such as obesity (BMI > 40 kg/m2), uncontrolled diabetes (HbA1c > 53 mmol/mol), immunosuppression, or recent neoadjuvant chemotherapy or radiotherapy • Patient is currently participating in or has participated in another clinical study within the past 30 d before enrollment • Any patient who, at the discretion of the investigators, is not suitable for inclusion in the study • Planned axillary lymph node dissection

BMI, body mass index; HbA1c, glycated hemoglobin.

A simple unilateral mastectomy with wide excision of the breast tissue with or without sentinel node excision/biopsy was performed in accordance with institutional protocols. The procedures were conducted at 2 sites by 3 surgeons (U.S., J.W., W.F.A.). Following excision, the mass of the removed breast tissue was weighed. The OFM sleeve (Fig. 1) of the PACT device (ENIVO System, Aroa Biosurgery Limited) was rehydrated with sterile saline and then placed on the chest wall within the mastectomy cavity. The OFM sleeve was then sutured to the chest wall with a minimum of 6 absorbable sutures (2-0, Vicryl; Johnson & Johnson MedTech, Warsaw, IN) (Fig. 2A). The PACT drainage catheter was ported out though the skin in a typical fashion via stab incision at a distance from the surgical site incision and secured to the skin via a finger-trapping silk suture (Fig. 2B) with adherent bandaging and suture. Subcutaneous tissues of the primary incision were closed with 4-0 suture (Monocryl; Johnson & Johnson MedTech) and dermal tissues with 3-0 suture (Monocryl). Additionally, the drainage catheter was flushed with analgesic (0.5% ropivacaine, ~20 mL) (20 min dwell time) before closure in 5 participants (001–005) from one of the study sites, according to the local surgical protocol. The primary closure was dressed with an occlusive dressing or surgical adhesive dressing (DERMABOND PRINEO Skin Closure System, Johnson & Johnson MedTech) (Fig. 2C). Following primary closure and before recovery, the PACT device was turned on and monitored to ensure stable operation before the participant was taken to recovery.

Fig. 1.

Representative images of the PACT device. A, Handheld, portable, programmable pump and controller. B, Fluid collection bag with internal fluid absorption packets. C, OFM sleeve fitted to the dual lumen drainage catheter.

Fig. 2.

Representative intraoperative, postoperative, and follow-up images. A, Placement of the drainage catheter with the OFM sleeve secured to the chest wall. B, After primary closure and before dressings were applied, with the drainage catheter secured at the exit site. C, Secondary dressings at the incisional closure and exit site. D, After removal of the drainage catheter. E, USS assessment of fluid volume within the surgical site. F, Postoperative follow-up (3 mo) of the incision and exit site.

All participants remained inpatient for 1–2 days after surgery and were discharged home at the discretion of the surgeon. Postoperative analgesic and antibiotics were prescribed according to institutional protocols and the discretion of the surgeon. Fluid collected in the drainage reservoir (Fig. 1) was recorded daily and measured by the mass of the fluid (g). Participants resumed daily activities, which included showering as per the surgeons’ routine postoperative instructions. The first dressing change, both at the incision and exit sites, was conducted on postoperative day 7. At the discretion of the surgeon, the PACT drainage catheter was removed at approximately 7 days postoperatively or when the fluid output was less than 30 mL in a 24-hour period (mL/d) (Fig. 2D). The OFM sleeve portion of the system remained in place, deep to the subcutaneous tissue. The exit site was then dressed. At approximately 7 days (postoperative day 14) following removal of the drainage catheter, an ultrasound scan (USS) was conducted at both the mastectomy site and the axillary region (Fig. 2E). USS assessment was performed using either a Equip 5G (Philips Healthcare, Netherlands) or Aplio i600 (Canon Medical Systems, Japan) ultrasound, using an L18-4 ultrasound transducer probe (Konica Minolta, Japan). The volume (cm³) of any accumulated fluid was determined for both the mastectomy site and axillary region. Participants were followed up for a 3-month period (Fig. 2F) and assessed for postoperative complications.

RESULTS

A total of 10 participants who met the inclusion and exclusion criteria were included in this study (Table 2). The mean patient age was 61.9 ± 16.1 years, with a mean body mass index of 27.6 ± 3.3. Six participants were European, 3 participants were New Zealand Māori, and 1 participant was Asian. No participants had a history of chemotherapy or radiotherapy. Eight participants (70%) had a diagnosis of cancer, 1 participant had a prophylactic mastectomy, and 1 participant was diagnosed with a benign phyllodes tumor. Of the 8 participants with a preoperative cancer diagnosis, 2 were diagnosed with invasive breast carcinoma (participant 001 was estrogen and progesterone receptor positive, human epidermal growth factor receptor 2 negative), 2 with invasive ductal carcinoma, 1 with invasive lobular carcinoma, 1 with ductal carcinoma in situ, 1 with micropapillary carcinoma, and 1 with lobular breast cancer (Table 2). Genetic disorders were either negative or not available for the 10 participants. Sentinel node biopsy was performed on 70% of participants (n = 7), 1 of whom progressed to axillary node clearance (ANC) (Table 3). No nodal dissections were performed on 3 (30%) patients. The mean weight of excised breast tissue was 793.7 ± 353.9 g (Table 3). The median length of stay was 1 day (interquartile range [IQR] 1–2 d).

Table 2.

Patient Demographics

ID	Age, y	Ethnicity	BMI, kg/m2	Nicotine Usage	HbAc1, mmol/mol	HTN	Serum Albumin, g/L	Indication for Surgery	Type of Cancer	Cancer Stage
001	47	Pakeha	22.2	No	NA	No	38	Cancer	Invasive breast carcinoma, ER/PR+, HER2−	IV
002	68	Māori	24.6	No	38	No	34	Cancer	Ductal carcinoma in situ	0
003	83	Pakeha	28.0	Yes	33	No	36	Cancer	Micropapillary breast cancer	III
004	76	Pakeha	26.6	Former tobacco user	38	Yes	NA	PPX	NA	NA
005	64	Asian	27.0	No	49	Yes	38	Cancer	Invasive breast carcinoma	II
006	33	Māori	25.0	Yes	NA	No	NA	Tumor	Benign phyllodes tumor	NA
007	62	Pakeha	30.0	Yes	NA	No	NA	Cancer	Lobular cancer	I
008	58	Māori	32.0	No	NA	No	NA	Cancer	Invasive duct carcinoma	I
009	81	Pakeha	28.0	No	44	Yes	34	Cancer	Invasive lobular cancer	I
010	47	Pakeha	33.0	No	35	No	35	Cancer	Invasive duct carcinoma	I
Mean ± SD	61.9 ± 16.1	—	27.6 ± 3.3	—	39.5 ± 5.9	—	35.83 ± 1.8	—	—	—
Median (IQR)	63.0 (47.0–77.0)	—	27.5 (24.9–30.5)	—	38.0 (34.5–45.2)	—	35.5 (34.0–38.0)	—	—	—

BMI, body mass index; ER/PR+, estrogen and progesterone receptor positive; HbA1c, glycated hemoglobin; HER2-, human epidermal growth factor receptor 2 negative; HTN, hypertension; NA, not available; PPX, prophylactic.

Table 3.

Intraoperative Outcomes and LOS

ID	Mastectomy Location	Node Biopsy	Weight of Excised Tissue, g	LOS, d
001	Right	Sentinel (level 2 axillary node dissection)	412	2
002	Left	Sentinel	375	1
003	Right	Sentinel	782	1
004	Right	None	533	1
005	Right	Sentinel	569	1
006	Right	None	1526	1
007	Right	Sentinel	1060	1
008	Right	None	960	1
009	Left	Sentinel	723	2
010	Left	Sentinel	997	2
Mean ± SD	—	—	793.7 ± 353.9	1.3 ± 0.5
Median (IQR)	—	—	752.5 (502.8–1013.0)	1 (1–2)

LOS, length of stay.

Fluid output was variable across participants, and at postoperative day 1, fluid collection volume ranged from 16.1 to 218.0 mL (Fig. 3). Fluid output generally decreased daily until a threshold of less than 30 mL/d was reached, at which point the drainage catheter was removed (Fig. 3). The cumulative mean fluid output collected by the PACT device was 306.2 ± 163.7 mL (Table 4). The mean time to drainage catheter removal was 6.5 ± 1.5 days (Table 4). No incidence of clinically relevant seroma was observed at the removal of the drainage catheter.

Fig. 3.

Postoperative fluid collection volumes. Error bars represent the standard error of the mean. The dotted line represents the 30 mL/d threshold where standard-of-care drains are typically removed.

Table 4.

Fluid Output Volume and Time to Drainage Catheter Removal

ID	Cumulative Fluid Volume, mL	Time to Drainage Catheter Removal, d
001	474.8	8
002	149.8	5
003	318.0	6
004	214.0	5
005	242.5	5
006	42.3	5
007	346.8	7
008	614.4	7
009	393.6	9
010	265.5	8
Mean ± SD	306.2 ± 163.7	6.5 ± 1.5
Median (IQR)	291.8 (198.0–413.9)	6.5 (5.0–8.0)

USS was performed approximately 14 days after surgery to assess fluid accumulation at both the mastectomy site and the axillary region (Table 5). The mean time to USS assessment was 14.5 ± 3.2 days. Axillary fluid volume at USS assessment varied widely among participants with a range of 0.0–42.4 mL with a median fluid volume of 0.5 mL (IQR: 0.0–15.9 mL). Mastectomy site fluid volume at USS assessment also varied widely among participants with a range of 0.0–278.0 mL and a median fluid volume of 6.9 mL (IQR: 0.0–66.2 mL). In 50% of participants, no fluid was detected by USS at the mastectomy site.

Table 5.

USS Assessment Outcomes

ID	Time Elapsed to USS, d	Axilla Volume, mL	Mastectomy (Chest) Volume, mL
001	15	36.8	0.0
002	12	0.0	0.0
003	13	42.4	0.0
004	11	8.9	0.0
005	11	2.8	13.7
006	22	0.0	0.0
007	14	1.1	38.0
008	16	0.0	278.0
009	16	0.0	66.4
010	15	0.0	66.1
Mean ± SD	14.5 ± 3.2	9.2 ± 16.3	46.4 ± 85.9
Median (IQR)	14.5 (11.8–16.0)	0.5 (0.0–15.9)	6.9 (0.0–66.2)

During the course of treatment, no device-related adverse events were reported. SSOs were monitored both at the exit site and the mastectomy site throughout the course of the study and at the final 3-month postoperative assessment. Two instances (20%) of bruising at the exit site while the drainage catheter was in place were reported (Table 6). Two instances (20%) of mild erythema at the incisional site were reported while the drainage catheter was in place (Table 6). Following drainage catheter removal, no SSOs were reported at the exit site. There was a single instance (10%) of dehiscence at the incisional site that occurred 34 days following drainage catheter removal and healed without further incidence by the 3-month follow-up. In 1 participant (10%), a superficial infection developed 4 days following drainage catheter removal. The superficial infection was resolved at approximately 41 days following a short hospitalization and course of antibiotics. One participant (10%) had an unusually high volume of fluid observed via USS assessment (278.0 mL, Table 5), and this participant developed a clinically significant seroma that required aspiration. Once aspirated, the participant healed uneventfully by the 3-month follow-up. Median patient-reported pain was 1 (IQR: 0–5) at drainage catheter removal (~7 d postoperatively) and 1 (IQR: 0–2) at USS assessment (~14 d postoperatively).

Table 6.

SSOs and Adverse Events

ID	Exit Site	Mastectomy Site	Resolved at 3 mo
001	None	None	—
002	Bruising	None	Yes
003	None	Dehiscence (34 d after catheter removal)	Yes
004	Bruising	None	Yes
005	None	None	—
006	None	Erythema	Yes
007	None	Erythema Superficial infection (4 d after catheter removal)	Yes
008	None	Seroma (9 d after catheter removal)	Yes
009	None	None	—
010	None	None	—

DISCUSSION

This study evaluated the safety of the PACT device in human participants undergoing simple unilateral mastectomy. As this was a first-in-human study, a carefully considered SSO monitoring schema was implemented to ensure evaluation of the exit and incisional sites during the postoperative period (up to 3 mo). In this way, all SSOs were recorded and reported herein, independent of the severity of the complication. The 2 adverse events recorded at the exit site (Table 6) were defined as minor bruising likely due to the stab incision used to create the exit site during drain placement. In both cases, no further intervention was required, and both resolved before the 3-month follow-up. In participant 007, mild erythema progressed to a superficial infection of the mastectomy incision 4 days following removal of the drainage catheter. The infection did not extend to the deeper tissue structures and was localized to the primary wound at the mastectomy site and resolved with a course of antibiotics. It was concluded that the superficial infection was not related to the device drainage catheter, as this had been removed 4 days before and the infection did not extend into the deeper tissues.

Noninfectious wound complications, such as dehiscence, are a source of concern in mastectomy with and without reconstruction.²² In this study, a single participant (10%) (participant 003) experienced dehiscence at the mastectomy site 34 days after drainage catheter removal. The dehiscence was categorized as minor and healed without intervention by the 3-month follow-up. Owing to the event occurring at a prolonged time point following drainage catheter removal and that the wound was undergoing healthy healing at the prior follow-up, the dehiscence was not considered to be directly related to the PACT device.

Formation of postoperative seroma/hematoma at the surgical site is a potential source of complication in any major surgical intervention and is important in mastectomy, as a large volume of well-vascularized tissue is often excised. One unique end point of the current study was a standardized USS of all participants to estimate the volume of any accumulated fluid, either at the mastectomy site or in the axilla region. There is no consensus in the literature as to what fluid volume constitutes a clinically significant “seroma.” Smaller volumes of accumulated fluid can typically be managed via conservative observation as the fluid will eventually resorb. Larger fluid volumes become clinically relevant when they are associated with pain, increased risk of infection, and loss of function at the affected site. However, the volume threshold for clinical intervention is not clearly defined. For example, Kazzam and Ng¹ proposed a general threshold of greater than 75–100 mL as requiring surgical intervention, whereas Nickerson et al²³ proposed greater than 50 mL as requiring surgical intervention in Morel-Lavallée lesions. Postoperative fluid was detectable by USS in 5 patients at the mastectomy treatment area and 5 patients in the axilla region (Table 5). It should be noted that the PACT drainage catheter did not extend into the axilla region, so fluid accumulation in this area was not treated by the investigational device per se. As fluid can accumulate in the axilla after sentinel lymph node biopsy or ANC, and particularly in the case of ANC, the axillary dead space may connect internally with the mastectomy site. Therefore, for completeness, we scanned the axilla as well as the mastectomy site, even though the investigational device was only placed into the breast cavity. At the mastectomy treatment area, fluid volumes estimated from USS ranged from 0 to 278.0 mL, with half the participants having no detectable fluid at the treatment site. In the singular instance (10%), a clinically relevant seroma developed (participant 008), which was detected by USS (278.0 mL). The participant had an excised tissue mass of approximately 960 g, which was substantially greater than the median of the study (752.5 g). It is known that high-drain fluid output is associated with an increased risk of seroma formation after mastectomy.³ Consistent with this, participant 008 had a cumulative fluid volume output of approximately 614 mL, which was more than twice the median fluid volume output (291.8 mL). The seroma was diagnosed 9 days after removal of the PACT drainage catheter and required aspiration. The participant recovered uneventfully without further complications at the 3-month follow-up. Seromas requiring surgical intervention have been reported as high as 73%,²⁴ and meta-analysis studies have reported highly variable ranges of seroma formation from 22% to 43%.¹² The 10% seroma incidence for the current study falls at the lower end of the reported postmastectomy seroma incidence, suggesting that the PACT device may reduce seroma complications as designed.

Prior in vivo studies have demonstrated that the PACT device was more effective in fluid removal than a standard surgical drain.¹⁵ In this prior in vivo study, mean total fluid removal (during 14 d) with the PACT device was 178.4 ± 23.2 mL, versus 64.1 ± 14.8 mL with a standard surgical drain. In the current study, the cumulative fluid volume collected by the PACT device throughout the course of the study was 306.2 ± 163.7 mL (Table 4). This falls within the mean range of values for traditional drain outputs reported in mastectomy studies between approximately 155 and 570 mL.^24–26 However, controlled comparative studies will be required to assess the relative fluid output of PACT devices versus traditional drains in relevant human procedures. During the course of treatment, there were no instances of drain blockage or migration resulting in a postoperative complication. Based on structured participant feedback (data not shown), the PACT device was well tolerated, and participants were able to maintain daily activities such as ambulation while the catheter was in place.

The current study has all the limitations of a pilot investigation, including the limited sample size and lack of a control arm. However, we have shown in this limited cohort that the PACT device was safe for the removal of postoperative fluid postmastectomy. Additionally, it should be noted that the use of the PACT device may be further optimized. For example, in the current study, the PACT drainage catheter was removed when daily fluid output reached less than 30 mL/d. This limit was set based on the clinical guidelines for standard surgical drains, but this may not necessarily be optimal for tissue apposition using the PACT device. For example, participant 008 recorded 75 and 13.2 mL on the 2 consecutive days before the removal of the drainage catheter. Prior in vivo studies¹⁵ have demonstrated that surgical defects treated with the PACT device had significantly improved tissue apposition between subcutaneous tissue layers. In the current human study, we have not been able to directly measure tissue apposition per se, but have instead used USS and seroma formation to indirectly measure tissue apposition at the mastectomy site. Future studies would benefit from a robust noninvasive method to quantify the degree of tissue apposition achieved with the PACT device.

CONCLUSIONS

The PACT device performed its intended function in simple unilateral mastectomy. A single clinically relevant seroma was reported, suggesting controlled studies are warranted to quantify the potential reduction in SSOs afforded by the PACT device.

DISCLOSURES

Mason and May are shareholders and employees of Aroa Biosurgery Limited. The other authors have no financial interest to declare in relation to the content of this article. Funding for this study was provided by Aroa Biosurgery Limited.

ACKNOWLEDGMENTS

The authors would like to thank the research staff at Aotearoa Clinical Trials (Auckland, New Zealand), as well as the surgical teams at Te Whatu Ora Counties Manukau (Auckland, New Zealand) and Te Whatu Ora - Te Tai Tokerau (Whangarei, New Zealand). The authors wish to acknowledge Andrew W. Ross, DO (Medical Writer, Aroa Biosurgery Limited) for assistance in the preparation of this article, and Nina Slabkevich, Sarah Williamson, and Hamish Rose (Aroa Biosurgery Limited) for assistance in the execution of the study.