Currently submitted to: JMIR Research Protocols
Date Submitted: Jul 14, 2026
Open Peer Review Period: Jul 15, 2026 - Sep 9, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Comparative Study of the Safety and Effectiveness of Papaya Dressing Versus 10% Povidone-Iodine for Surgical Site Infection Management: Protocol for a Randomised Controlled Trial (PAPAYA-SSI Trial)
ABSTRACT
Background:
Surgical site infections (SSIs) contribute substantially to postoperative morbidity through delayed healing, prolonged hospitalisation, and increased wound care requirements. 10% Povidone-iodine is standard of care in many Indian tertiary care hospitals; however, prolonged use raises concerns about cytotoxicity to fibroblasts and delayed healing. Carica papaya contains the proteolytic enzymes papain and chymopapain, which selectively debride necrotic tissue. Limited randomised controlled evidence exists directly comparing papaya dressing with povidone-iodine for the management of postoperative SSIs.
Objective:
The primary objective is to compare time to healthy granulation tissue formation between papaya dressing and 10% povidone-iodine in patients with postoperative SSIs. Secondary objectives include comparing complete wound healing time, hospital stay, dressing frequency, need for surgical debridement, treatment costs, adverse events, and patient satisfaction.
Methods:
This is a randomised, open-label, parallel-group, superiority trial (the PAPAYA-SSI Trial) enrolling 138 patients (69 per group) with confirmed SSIs at a single tertiary care centre in Nagpur, India. Participants are allocated 1:1 to daily wound dressing with 10% povidone-iodine solution (Group A, control) or twice-daily application of freshly prepared grated semi-ripe Carica papaya pulp at a standardised dose of 10 grams per 10 cm2 of wound surface area (Group B, intervention). The primary outcome is time to first documentation of healthy granulation tissue, defined clinically and supported by the Pressure Ulcer Scale for Healing (PUSH) tool v3.0 granulation subscore, assessed daily until Day 14. Secondary outcomes include complete wound healing time, total hospital stay, number of dressing changes, need for additional surgical debridement, cost of treatment per patient, adverse events graded by CTCAE v5.0, and patient satisfaction assessed by a 5-point Likert scale. Analysis will be by intention-to-treat.
Results:
As of May 2026, recruitment is ongoing, with 88 of the target 138 participants (63.8%) enrolled. No serious adverse events (CTCAE grade 3 or above) have been recorded to date. Final results are expected following completion of trial in June 2027.
Conclusions:
The current study is designed to generate evidence regarding the efficacy and safety of papaya dressing compared with povidone-iodine dressing in managing SSIs. Results may inform future wound care practice and larger multicentre studies in resource-limited settings. Clinical Trial: CTRI/2023/08/057035 (Registered: August 29, 2023, prospectively; www.ctri.nic.in) last modified June 10, 2026.
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