Clinical and technical evidence

Advice

Published evidence
Overall assessment of the evidence
Recent and ongoing studies

Clinical and technical evidence

A literature search was carried out for this briefing in accordance with the interim process and methods statement. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting mibs@nice.org.uk.

Published evidence

Five studies, published as full journal articles, are summarised in this briefing including 1 case series study (Topaz et al. 2012), 3 case reports (Topaz et al. 2014a; Topaz et al. 2014b; Zhu et al. 2015) and a single technical report (Katzengold et al. 2016). A total of 41 patients were included in these 5 studies, with clinical outcomes reported for 38 patients and the wounds from 3 patients were used to develop a model to assess stresses applied to wounds.

Table 2 summarises the clinical evidence as well as its strengths and limitations.

Overall assessment of the evidence

Overall, the current evidence for the TopClosure Tension Relief System (TRS) is of very low quality, comprised mainly of individual case reports and all but 1 study (Zhu et al.) funded and done by the manufacturer. There is no evidence available to compare the TopClosure TRS with other methods of wound closure, such as direct stitching, skin graft, flap or internal tissue expansion.

The existing evidence indicates that it is a safe and possibly effective system for wound closure and may result in a better cosmetic outcome for patients. For example, if a skin flap is avoided then the patient would not have scarring at the donor site.

The manufacturer has reported that a study comparing the TopClosure TRS with stitches in people having mastectomy has been submitted for publication, which could add comparative evidence.

Table 2 Summary of selected studies

Katzengold et al. (2016)
Study size, design and location	Technical study modelling the biomechanical efficacy of TopClosure TRS. Data from 3 patients used for computational FE modelling. Israel.
Intervention and comparators	TopClosure TRS. Surgical suturing. The study used information from wounds in 3 patients to create simulations. All the wounds were treated using the TopClosure TRS. The model was based on the actual number of attachment plates used to close leg and scalp wounds (1 set or 2 plates), and a back wound (3 sets or 6 plates).
Key outcomes	Closure using TopClosure TRS and tension sutures introduced local stresses in the skin and deeper tissues. The stresses reached maximal values around TopClosure's attachment plates and the suture insertion sites. Peak effective stresses on the skin increased with the level of closure and were 1 to 2 times lower with TopClosure TRS than with tension sutures because the attachment plates distributed the deformations more uniformly.
Strengths and limitations	TopClosure was compared with surgical suturing using data from 3 real wounds in a simulation. Modelling work is based on assumptions which may not be accurate and may not reflect the real-life clinical scenario. The simulations were not fully time-dependent because they did not account for skin elasticity.
Topaz et al. (2014a)
Study size, design and location	Retrospective case series. Eight patients needing resection of 9 scalp tumours. Israel.
Intervention and comparator	TopClosure TRS. No comparator.
Key outcomes	All wounds were closed by immediate or delayed direct primary closure; 2 wounds had immediate primary closure and 7 wounds were closed using mechanical creep. No anaesthesia was needed during the gradual process of pulling the wound edges together. Six patients needed hospitalisation, for an average 2.5 days. No undermining was needed and no drainage was applied. Skin grafts or flaps were not needed. There were no significant complications, adverse events or device failures.
Strengths and limitations	Retrospective study with small sample size and no comparator. The study was authored by the developer and chairperson of the company that makes the device.
Topaz et al. (2014b)
Study size, design and location	Case reports. Three patients with large wounds which were not suitable for closure using sutures: 1 head injury, 1 wide excision of melanoma, 1 with wound 26 cm wide after a tumour resection). Israel.
Intervention and comparator	TopClosure TRS for wound closure. No comparator.
Key outcomes	The wounds of all 3 patients closed with minimal and acceptable scarring. The post-operative course was complicated in one patient by minor rupture of the wound edges because the TopClosure TRS plates and tension sutures were not well applied and the patient did not follow advice.
Strengths and limitations	TopClosure was applied in 3 different clinical scenarios with similar success. There were only 3 patients in the study and no comparator or control group. The study was authored by the developer and chairperson of the company that makes the device.
Topaz et al. (2012)
Study size, design and location	Case series of 21 wounds in 20 patients plus case reports for 6 additional patients giving a total of 26 patients. Israel.
Intervention and comparator	TopClosure TRS. No comparator.
Key outcomes	Summary data for 21 wounds in 20 patients showed a positive outcome with successful wound closure and minimal scarring in all patients. The case reports for 6 patients recorded complete wound closure, and 5 of them were satisfied with the appearance of the resulting scars.
Strengths and limitations	The TopClosure TRS was used in various conditions including wound closure after tumour excision, soft tissue damage from electric burns, infected surgical wounds and scar revision after reconstructive surgery. The number of patients was low, with no comparator or control treatments. The study was authored by the developer and chairperson of the company that makes the device.
Zhu et al. (2015)
Study size, design and location	Case report. One patient; an otherwise healthy 10‑day‑old baby with a homogenous haemangioma that was completely removed, resulting in a 6.5 cm × 5.2 cm soft tissue scalp defect. China.
Intervention and comparator	TopClosure TRS. No comparator.
Key outcomes	TopClosure TRS was applied for 14 days to ensure wound closure. There was no ischaemia or necrosis of wound edges and the procedure was well tolerated, but there was no detail on how that tolerance had been assessed. Complete wound closure with a minimally depressed scar was reported at 6‑month follow-up.
Strengths and limitations	Single case report, no comparator or control treatments.

Recent and ongoing studies

Efficacy of TopClosure System in Healing Complicated Pacemaker Wounds. ClinicalTrials.gov identifier: NCT01665963. Status: unknown. Indication: wounds and injuries. Devices: TopClosure TRS; pressure bandage.