Does an absorbable poloxamer and sodium alginate gel applied during lower-back (lumbar) spine surgery reduce scar tissue and improve recovery?

ISRCTN	ISRCTN14269651
DOI	https://doi.org/10.1186/ISRCTN14269651
Sponsor	University of Indonesia
Funder	Fakultas Kedokteran, Universitas Indonesia

Submission date: 05/06/2026
Registration date: 08/07/2026
Last edited: 15/06/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Latsarizul Alfariq Senja Belantara
Principal investigator, Scientific, Public

Jl. Prof. Dr. Bahder Djohan, Pondok Cina, Kecamatan Beji, Kota Depok, Jawa Barat
Depok
16424
Indonesia

ORCID ID	0009-0000-3203-0034
Phone	+62 (0)813 1586 9791
Email	latsarizul.alfariq@rs.ui.ac.id

Mr Dewa Gde Prema Ananda
Public

MT Haryono St No.8, RT.11/RW.5
Jakarta
12810
Indonesia

ORCID ID	0009-0008-3704-9787
Phone	+62 (0)81310160634
Email	prema.ananda97@gmail.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Active
Assignment	Parallel
Purpose	Prevention
Scientific title	Comparison of clinical and radiological outcomes in patients undergoing lumbar spine surgery with versus without an intraoperative poloxamer and sodium alginate-based barrier agent (Guardix-SG): a randomised controlled trial
Study objectives	To compare clinical outcomes (low back pain VAS, leg pain VAS, Oswestry Disability Index) and the radiological outcome (severity of epidural fibrosis on MRI) between patients receiving an intraoperative poloxamer and sodium alginate barrier agent (Guardix-SG) versus no barrier agent after lumbar spine surgery. Hypothesis: the barrier agent improves clinical outcomes and reduces epidural fibrosis.
Ethics approval(s)	Approved 15/07/2025, Ethics committee of Rumah Sakit Universitas Indonesia (Jl. Prof. Dr. Bahder Djohan, Pondok Cina, Kecamatan Beji, Kota Depok, Jawa Barat, Depok, 16424, Indonesia; +62 (0)212150829292; kep@rs.ui.ac.id), ref: 2025-06-109
Health condition(s) or problem(s) studied	Patients undergoing lumbar spine decompression surgery (with or without stabilization); prevention of postoperative epidural fibrosis/failed back surgery syndrome
Intervention	Intervention arm (n = 10): Standard lumbar decompression (with or without instrumentation). At the end of surgery, after decompression/instrumentation, haemostasis, warm saline irrigation and suction to dryness, one 3 g syringe of Guardix-SG per decompression level is applied directly over the dura mater, moving from the cranial edge of the laminectomy defect caudally to cover the dura, nerve roots and epidural space. The gel is left for 15–30 seconds to set; the field is not re-irrigated afterwards; any drain is placed laterally, away from the gel; the wound is closed in layers. Control arm (n = 10): Identical standard lumbar spine surgery without any barrier agent. Allocation by random number table (1:1). Surgery is performed by consultant spine orthopaedic surgeons. Participants and outcome assessors blinded; operating surgeon not blinded. Clinical follow-up at 1, 3 and 6 months; contrast-enhanced MRI at 6 months. Analysed by intention-to-treat.
Intervention type	Drug/Device
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Guardix-SG (cross-linked poloxamer + sodium alginate + calcium chloride; manufacturer Genewel/Dongsung Co., Seongnam, Republic of Korea)
Primary outcome measure(s)	Low back pain and leg pain measured using the Visual Analogue Scale at preoperative baseline and 1, 3 and 6 months postoperatively Disability measured using the Oswestry Disability Index at preoperative baseline and 1, 3 and 6 months postoperatively Severity of epidural fibrosis measured using contrast-enhanced (gadolinium) T2 axial MRI, graded 0–4 across four quadrants on five consecutive slices and averaged (Ross-type grading), at 6 months postoperatively
Key secondary outcome measure(s)	Postoperative complications measured using any deviation from the normal postoperative course at through 6 months
Completion date	31/03/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	99 Years
Sex	All
Target sample size at registration	20
Total final enrolment	20
Key inclusion criteria	1. Undergoing lumbar decompression surgery (with or without stabilisation) at the participating hospitals during the study period 2. Aged 18 years or older 3. Willing to participate in the study (provided consent)
Key exclusion criteria	1. History of previous spine surgery 2. Immune disorder or autoimmune disease 3. Spinal malignancy
Date of first enrolment	29/07/2025
Date of final enrolment	30/09/2025

Locations

Countries of recruitment

Indonesia

Study participating centres

Dr. Cipto Mangunkusumo Hospital

Indonesia

Fatmawati Hospital

Indonesia

Universitas Indonesia Hospital

Indonesia

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

08/06/2026: Study's existence confirmed by the ethics committee of Rumah Sakit Universitas Indonesia.